Air (DrugBank: -)
7 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 3 | 脊髄性筋萎縮症 | 1 |
| 51 | 全身性強皮症 | 2 |
| 58 | 肥大型心筋症 | 2 |
| 85 | 特発性間質性肺炎 | 6 |
| 97 | 潰瘍性大腸炎 | 3 |
| 193 | プラダー・ウィリ症候群 | 1 |
| 299 | 嚢胞性線維症 | 90 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT01522079 (ClinicalTrials.gov) | January 2011 | 24/1/2012 | Spinal Muscular Atrophy and Cardiac Autonomic Function | Spinal Muscular Atrophy and Cardiac Autonomic Function | Spinal Muscular Atrophy | Procedure: Air stacking manuever | Centro Universitário Augusto Motta | NULL | Completed | 5 Years | 25 Years | Both | 9 | N/A | NULL |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04627857 (ClinicalTrials.gov) | January 1, 2021 | 6/11/2020 | Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic Sclerosis | Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic Sclerosis | Scleroderma Systemic | Device: Manual toothbrush;Device: Manual toothbrush and water flosser (Philips Sonicare AirFloss);Device: Sonic toothbrush;Device: Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss) | University Hospital, Strasbourg, France | NULL | Not yet recruiting | 18 Years | N/A | All | 100 | N/A | NULL |
| 2 | NCT00204763 (ClinicalTrials.gov) | January 2004 | 13/9/2005 | Comparison of Esophageal and Anorectal Manometry Catheters | Comparison of Solid-State Esophageal Manometry and Water Perfused Anorectal Manometry Catheters With Air Filled Multi-Balloon Esophageal and Anorectal Manometry Catheters | Achalasia;Nutcracker Esophagus;Scleroderma;Esophageal Spasm;Fecal Incontinence | Device: Air filled balloon catheter;Device: Solid state catheter | University of Utah | Clinical Innovations | Terminated | 18 Years | 80 Years | Both | 5 | Phase 4 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04129905 (ClinicalTrials.gov) | October 21, 2019 | 12/6/2019 | Assessment of the Relations Between Endothelial and Venous Dysfunctions and Left Ventricular Obstruction in Genetic Hypertrophic Cardiomyopathies | Assessment of the Relations Between Endothelial and Venous Dysfunctions and Left Ventricular Obstruction in Genetic Hypertrophic Cardiomyopathies | Hypertrophic Cardiomyopathy;Endothelial Dysfunction | Biological: BNP blood sample test;Diagnostic Test: Electrocardiogram;Diagnostic Test: Holter ECG;Diagnostic Test: Echocardiography;Diagnostic Test: Air venous plethysmography;Diagnostic Test: Upper member arterial Doppler echography with analysis of FMD;Biological: Endothelial function biomarkers | University Hospital, Bordeaux | Fédération Française de Cardiologie;Fondation Bordeaux Université;Amicus Therapeutics | Not yet recruiting | 18 Years | N/A | All | 40 | N/A | France |
| 2 | NCT03049995 (ClinicalTrials.gov) | November 2016 | 2/2/2017 | Stress Echo 2020 - The International Stress Echo Study | The International Stress Echo Study in Ischemic and Non-ischemic Heart Disease | Coronary Artery Disease;Heart Failure;Hypertrophic Cardiomyopathy;Aortic Valve Disease;Athletes Heart;Tetralogy of Fallot;Pulmonary Arterial Hypertension | Procedure: Left ventricular contractile reserve SE;Procedure: B-lines SE;Procedure: Left ventricular outflow tract gradient SE;Procedure: Diastolic function SE;Procedure: Mitral regurgitation SE;Procedure: Pulmonary hemodynamics SE;Procedure: Coronary flow reserve SE | Fatebenefratelli Hospital | Institute of Clinical Physiology, CNR, Pisa,Italy;Salerno Hospital, Italy;Monaldi Hospital, Napoli, Italy;University of Pisa, Italy;San Luca Hospital, Lucca, Italy;Careggi University Hospital, Florence, Italy;Federico II University, Napoli, Italy;San Carlo Public Hospital, Potenza, Italy;Royal Brompton & Harefield NHS Foundation Trust;Ospedale dell'Angelo, Venezia-Mestre, Italy;University of Parma;Hospital Clinics, Trieste, Italy;Hospital de Clinicas de Porto Alegre - Universidade Federal do Rio Grande do Sul, Porto Alegre, Brasil;Hospital San José, Criciuma, Brasil;Hospital San Vicente de Paulo, Passo Fundo, Brasil;University of Belgrade,Serbia;University of Szeged, Hungary;Elisabeth Hospital, Hodmezovasarhely, Hungary;Sandro Pertini Hospital, Rome, Italy;Hospital Clinics, Bari, Italy;Ospedale Nottola, Siena, Italy;University of Catania, Italy;Medika Cardiocenter, Saint Petersburg, Russian Federation;Acibadem City Clinic, University Hospital,Sofia,Bulgaria;Investigaciones Medicas, Buenos Aires, Argentina;Tomsk National Research Scientific Centre of Russian Academy of Sciences, Tomsk, Russian Federation | Recruiting | 18 Years | 85 Years | All | 300 | N/A | Italy |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03688334 (ClinicalTrials.gov) | June 1, 2018 | 20/9/2018 | Acute Effects of Oxygen Supplementation Among IPF Patients | Acute Effects of Oxygen Supplementation During Exercise Among Patients With Idiopathic Pulmonary Fibrosis Without Resting Hypoxemia | Idiopathic Pulmonary Fibrosis | Drug: Oxygen 40 %;Drug: Medical air (sham O2) | George Papanicolaou Hospital | NULL | Unknown status | 18 Years | 80 Years | All | 15 | N/A | Greece |
| 2 | NCT03050255 (ClinicalTrials.gov) | November 2016 | 25/11/2016 | Short-term Effects of Supplemental Oxygen in Patients With IPF | Short-term Effects of Supplemental Oxygen During Walking in Hypoxemic Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis (IPF) | Other: Medical air;Other: Oxygen (2Liter/min);Other: Oxygen (4Liter/min) | Schön Klinik Berchtesgadener Land | Linde AG | Completed | N/A | N/A | All | 53 | N/A | Germany |
| 3 | JPRN-UMIN000015508 | 2015/01/01 | 24/10/2014 | A prospective randomized, multicenter trial evaluating the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis. | A prospective randomized, multicenter trial evaluating the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis. - Combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis. | Idiopathic pulmonary fibrosis | Using Micro Air nebulizers and vibration mesh technology (NE-U07, Omron, Tokyo, Japan), patients receiving NAC combined with pirfenidone were treated twice daily with 352.4 mg of inhaled NAC, which was diluted with saline to a total volume of 6 mL for 48 weeks. Pirfenidone 1200-1800mg (control group) | Grant for Research on Diffuse Lung Disease from the Ministry of Health, Labour and Welfare of Japan. | NULL | Complete: follow-up complete | 40years-old | Not applicable | Male and Female | 150 | Not selected | Japan |
| 4 | JPRN-UMIN000005098 | 2011/02/01 | 18/02/2011 | A randomized trial of ambulatory oxygen in patients with idiopathic pulmonary fibrosis and desaturation but without resting hypoxemia | idiopathic pulmonary fibrosis | ambulatory oxygen ambulatory air | Department of Respiratory Medicine and Allergology, Kinki University School of Medicine | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 20 | Not selected | Japan | |
| 5 | JPRN-UMIN000016045 | 2009/10/03 | 26/12/2014 | A case-control study evaluating the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis. | A case-control study evaluating the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis. - Combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis. | Idiopathic pulmonary fibrosis | Using Micro Air nebulizers and vibration mesh technology (NE-U07, Omron, Tokyo, Japan), patients receiving NAC combined with pirfenidone were treated twice daily with 352.4 mg of inhaled NAC, which was diluted with saline to a total volume of 6 mL for 48 weeks. Pirfenidone 1200-1800mg (control group) | Department of Respiratory Medicine, Toho University Omori Medical Center, Tokyo | ,NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 20 | Not selected | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | JPRN-UMIN000025256 | 2009/01/01 | 13/12/2016 | Benefits of supplemental oxygen on exercise capacity and dyspnea in IPF patients | idiopathic pulmonary fibrosis | oxygen gas air gas | Tosei General Hospital | NULL | Complete: follow-up complete | Not applicable | 75years-old | Male and Female | 106 | Not applicable | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-UMIN000018801 | 2015/08/27 | 27/08/2015 | Efficasy of colonosocopy using carbon dioxide insufflation for the patients with ulcerative colitis | ulcerative colitis | Colonosocopy using carbon dioxide insufflation Colonosocopy using air insufflation | Osaka University, Graduate School of Medicine,Department of Gastroenterology and Hepatology | NULL | Recruiting | 16years-old | Not applicable | Male and Female | 250 | Not selected | Japan | |
| 2 | NCT02144350 (ClinicalTrials.gov) | August 2013 | 13/5/2014 | Hyperbaric Oxygen for Ulcerative Colitis | Hyperbaric Oxygen Therapy for Moderate to Severe Ulcerative Colitis Flares: A Multi-center Randomized Double Blind Sham Controlled Trial | Ulcerative Colitis | Procedure: Hyperbaric oxygen;Procedure: Sham Hyperbaric Air | Dartmouth-Hitchcock Medical Center | Mayo Clinic;University of Pittsburgh | Terminated | 18 Years | N/A | All | 18 | Phase 2;Phase 3 | United States |
| 3 | NCT01790061 (ClinicalTrials.gov) | November 2012 | 9/2/2013 | Standardized Fecal Microbiota Transplantation for Ulcerative Colitis | Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation in Patients With Moderate to Severe Ulcerative Colitis | Bacteria;Microbiota;Fecal Microbiota Transplantation;Inflammatory Bowel Disease;Ulcerative Colitis | Procedure: Standardized FMT;Drug: Traditional treatments | The Second Hospital of Nanjing Medical University | Air Force Military Medical University, China | Recruiting | 6 Years | 80 Years | All | 500 | Phase 2;Phase 3 | China |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03031626 (ClinicalTrials.gov) | September 1, 2016 | 20/1/2017 | Oxygen Versus Medical Air for Treatment of CSA in Prader Will Syndrome | Comparison of Therapeutic Oxygen Versus Medical Air for the Treatment of Central Sleep Apnea in Infants and Children With Prader Willi Syndrome: A Proof of Concept Study | Sleep Apnea, Central;Prader-Willi Syndrome | Biological: Medical Air vs Oxygen | The Hospital for Sick Children | NULL | Recruiting | N/A | 2 Years | All | 10 | Phase 4 | Canada |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2020-001762-11-GB (EUCTR) | 17/09/2020 | 23/07/2020 | A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial. | An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials | Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2;Phase 3 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | ||
| 2 | NCT04509661 (ClinicalTrials.gov) | September 1, 2020 | 22/4/2020 | Efficacy and Safety of Inhaled Bronchodilator in Non-CF Bronchiectasis With Airflow Limitation | Efficacy and Safety of Inhaled Bronchodilator in Non-cystic Fibrosis Bronchiectasis Patients With Airflow Limitation: a Multicenter, Open-label Randomized Controlled Trial | Bronchiectasis Adult | Drug: LABA/LAMA or Placebo inhalation | Shanghai Pulmonary Hospital, Shanghai, China | NULL | Not yet recruiting | 18 Years | N/A | All | 200 | Phase 4 | NULL |
| 3 | EUCTR2020-001762-11-HU (EUCTR) | 26/08/2020 | 02/07/2020 | A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial. | An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials | Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2;Phase 3 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | ||
| 4 | NCT04058340 (ClinicalTrials.gov) | July 30, 2019 | 12/8/2019 | Taste Receptors Regulation in CF Patients | The Effects of Taste Receptors Regulation in Upper Airway Innate Immunity of CF Patients | Cystic Fibrosis | Dietary Supplement: lactizole nebulization;Other: Placebo | Medical Universtity of Lodz | NULL | Recruiting | 6 Years | N/A | All | 30 | N/A | Poland |
| 5 | NCT03617718 (ClinicalTrials.gov) | November 1, 2018 | 19/7/2018 | Project 2 Airway Potential Hydrogen (pH) in Asthma | Methods to Identify and Treat Severe Asthma Patients Project 2: Airway pH Phenotyping | Cystic Fibrosis;Asthma;Severe Persistent Asthma;Healthy | Drug: Glycine Buffer | University Hospitals Cleveland Medical Center | National Institutes of Health (NIH) | Recruiting | 18 Years | 50 Years | All | 75 | Phase 1;Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT03593434 (ClinicalTrials.gov) | July 30, 2018 | 28/6/2018 | Airway Clearance Therapy on Hyperpolarized 129Xenon and MRI | The Effect of Airway Clearance Therapy on Hyperpolarized 129Xenon MRI Compared With Lung Clearance Index and Spirometry in Cystic Fibrosis | Cystic Fibrosis | Drug: hyperpolarized Xenon gas | Children's Hospital Medical Center, Cincinnati | National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | 6 Years | 21 Years | All | 20 | United States | |
| 7 | EUCTR2016-002749-42-NL (EUCTR) | 09/05/2018 | 29/08/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000113915;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Netherlands;Germany | ||
| 8 | EUCTR2016-002749-42-GR (EUCTR) | 12/01/2018 | 03/10/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000113915;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands | ||
| 9 | EUCTR2016-002749-42-DK (EUCTR) | 15/12/2017 | 11/10/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 21.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands | ||
| 10 | EUCTR2016-002749-42-IT (EUCTR) | 24/11/2017 | 14/09/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000113915;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | EUCTR2016-002749-42-GB (EUCTR) | 09/10/2017 | 25/07/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 21.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands | ||
| 12 | EUCTR2016-002749-42-DE (EUCTR) | 22/09/2017 | 02/08/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 21.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands | ||
| 13 | EUCTR2016-002749-42-BE (EUCTR) | 18/09/2017 | 24/07/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands | ||
| 14 | EUCTR2016-002749-42-AT (EUCTR) | 07/08/2017 | 27/07/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 21.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands | ||
| 15 | EUCTR2016-002749-42-ES (EUCTR) | 04/08/2017 | 08/08/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000113915;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | France;United States;Greece;Belgium;Spain;Ireland;Austria;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT03078088 (ClinicalTrials.gov) | June 15, 2017 | 1/3/2017 | Airway Alkalinization and Nasal Colonization | Airway Alkalinization and Nasal Colonization | Healthy Subjects;Cystic Fibrosis | Drug: Tham;Drug: Saline | Lakshmi Durairaj | NULL | Completed | 16 Years | N/A | All | 32 | Phase 1 | United States |
| 17 | EUCTR2015-003881-96-IT (EUCTR) | 17/05/2016 | 05/11/2020 | Clinical study to assess two different Pseudomonas aeruginosa eradication protocols in patients with cystic ¿brosis | Pseudomonas aeruginosa eradication in patients with cystic fibrosis: a randomised multicentre study comparing classic treatment protocols with classic treatment together with antibiotic treatment of upper airways. - Clinical study to assess two different Pseudomonas aeruginosa eradication protocols in patients with | cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: COLIMICINA - 1000000 U/4 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE PER USO INTRAMUSCOLARE1 FLACONCINO POLVERE + 1 FIALA SOLVENTE 4 ML Product Name: NA Product Code: [NA] INN or Proposed INN: COLISTIMETATO SODICO Other descriptive name: COLISTIN | AZIENDA OSPEDALIERO-UNIVERSITARIA MEYER | NULL | Not Recruiting | Female: yes Male: yes | 112 | Phase 3 | Italy | ||
| 18 | NCT02722122 (ClinicalTrials.gov) | May 2016 | 23/3/2016 | Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of AIR DNase™in Patients With Cystic Fibrosis Previously Treated With Pulmozyme® | A Proof-of-Concept, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of AIR DNase™in Patients With Cystic Fibrosis Previously Treated With Pulmozyme® | Cystic Fibrosis | Drug: AIR DNase™ | Protalix | NULL | Recruiting | 12 Years | N/A | Both | 15 | Phase 2 | Israel |
| 19 | EUCTR2015-002581-23-DE (EUCTR) | 20/04/2016 | 26/10/2015 | A study of safety and efficacy of JBT-101 in cystic fibrosis | A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis | Cystic FibrosisCystic Fibrosis is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections, fibrosis of the lungs and digestive tract and abnormal immune function. MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: JBT-101 Product Code: JBT-101 INN or Proposed INN: JBT-101 Other descriptive name: JBT-101 Product Name: JBT-101 Product Code: JBT-101 INN or Proposed INN: JBT-101 Other descriptive name: JBT-101 Product Name: JBT-101 Product Code: JBT-101 INN or Proposed INN: JBT-101 Other descriptive name: JBT-101 | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | France;United States;Poland;Belgium;Israel;Germany;Italy;United Kingdom | ||
| 20 | EUCTR2015-002581-23-FR (EUCTR) | 23/12/2015 | 18/01/2016 | A study of safety and efficacy of JBT-101 in cystic fibrosis | A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis | Cystic Fibrosis Cystic Fibrosis is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections, fibrosis of the lungs and digestive tract and abnormal immune function. MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | United States;France;Poland;Belgium;Israel;Germany;Italy;United Kingdom | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | EUCTR2015-002581-23-GB (EUCTR) | 22/12/2015 | 21/03/2016 | A study of safety and efficacy of JBT-101 in cystic fibrosis | A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis | Cystic Fibrosis Cystic Fibrosis is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections, fibrosis of the lungs and digestive tract and abnormal immune function. MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | France;United States;Poland;Belgium;Israel;Germany;Italy;United Kingdom | |||
| 22 | EUCTR2015-002581-23-BE (EUCTR) | 03/12/2015 | 12/10/2015 | A study of safety and efficacy of JBT-101 in cystic fibrosis | A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis | Cystic FibrosisCystic Fibrosis is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections, fibrosis of the lungs and digestive tract and abnormal immune function. MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: JBT-101 Product Code: JBT-101 INN or Proposed INN: JBT-101 Other descriptive name: JBT-101 | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | France;United States;Poland;Belgium;Israel;Germany;Italy;United Kingdom | ||
| 23 | NCT02605590 (ClinicalTrials.gov) | December 2015 | 10/11/2015 | Safety, Tolerability and Pharmacokinetics Study of AIR DNAse Administered by Inhalation to Healthy Adult Volunteers | A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose and Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of AIR-DNase When Administered by Inhalation to Healthy Adult Subjects | Cystic Fibrosis (CF) | Drug: AIR DNase;Drug: Placebo | Protalix | NULL | Completed | 18 Years | 55 Years | Male | 18 | Phase 1 | Israel |
| 24 | NCT03391414 (ClinicalTrials.gov) | August 2014 | 20/6/2012 | Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis | Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis | Cystic Fibrosis | Drug: hypertonic bicarbonate;Drug: sodium chloride | Joseph Pilewski | Cystic Fibrosis Foundation Therapeutics | Completed | 12 Years | N/A | All | 12 | Phase 1 | United States |
| 25 | EUCTR2014-001401-41-NL (EUCTR) | 29/07/2014 | 15/05/2014 | Once daily deep inhalation of tobramycin with smart nebulizer more effective to treat small airways disease in cystic fibrosis? | Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis - TAPAS study in patients with CF | Cystic Fibrosis and chronic infection with Pseudomonas aeruginosa;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Bramitob 300mg/4ml Nebuliser Solution | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 26 | Netherlands | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | EUCTR2011-000801-39-ES (EUCTR) | 25/07/2014 | 25/04/2014 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens? eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Ireland;Austria;Germany;Italy;Sweden | ||
| 27 | EUCTR2011-000801-39-AT (EUCTR) | 11/06/2014 | 24/04/2014 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Hungary;Ireland;Austria;Germany;Italy;Sweden | ||
| 28 | EUCTR2011-000801-39-HU (EUCTR) | 22/05/2014 | 03/04/2014 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Hungary;Ireland;Germany;Italy;Sweden | ||
| 29 | NCT01937325 (ClinicalTrials.gov) | February 2014 | 4/9/2013 | CPET in CF Patients With One G551D Mutation Taking VX770 | Airway Infection, Inflammatory Markers and Exercise Capacity in Patients With Cystic Fibrosis and at Least One G551D Mutation Taking VX770 (Ivacaftor) | Cystic Fibrosis | Drug: ivacaftor;Drug: placebo | The Alfred | NULL | Active, not recruiting | 16 Years | 70 Years | Both | 20 | Phase 4 | Australia |
| 30 | EUCTR2013-004488-30-NL (EUCTR) | 31/01/2014 | 11/12/2013 | Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis: pharmacokinetics (PK) | Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis: pharmacokinetics (PK) - TAPAS-PK study in patients with CF | Cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Bramitob INN or Proposed INN: TOBRAMYCIN Other descriptive name: TOBRAMYCIN | Haga Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | EUCTR2011-000801-39-IE (EUCTR) | 07/05/2013 | 12/02/2013 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Ireland;Germany;Italy;Sweden | ||
| 32 | NCT01586728 (ClinicalTrials.gov) | October 2012 | 18/1/2012 | Oxygen Therapy in Cystic Fibrosis | Indication and Benefits of Nocturnal Oxygen Therapy in Cystic Fibrosis | Cystic Fibrosis | Other: Air - oxygen;Other: Oxygen - Air | Assistance Publique - Hôpitaux de Paris | Vaincre la Mucoviscidose | Terminated | 6 Years | N/A | Both | 8 | N/A | France |
| 33 | NCT02201082 (ClinicalTrials.gov) | September 2012 | 20/2/2014 | Evaluation of the Timing of the Nebulization Related to the Physiotherapy Session | Cystic Fibrosis | Procedure: Airway clearance technique;Drug: Amikacin nebulization | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | NULL | Completed | 16 Years | 50 Years | Both | 15 | N/A | Belgium | |
| 34 | EUCTR2011-001255-36-AT (EUCTR) | 25/06/2012 | 18/10/2011 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 2 | France;United States;Belgium;Spain;Poland;Ireland;Austria;Netherlands;Germany;Italy | ||
| 35 | EUCTR2011-000801-39-IT (EUCTR) | 20/06/2012 | 21/06/2012 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens'eggs building a barrier in the respiratory tract against Pesudomonas germ in order to preventi infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT -PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially effects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbility and mortality. PA infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 14.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | MUKOVISZIDOSE E.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Germany;Italy;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | EUCTR2011-000801-39-BE (EUCTR) | 26/04/2012 | 09/01/2012 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | ||
| 37 | EUCTR2011-001362-18-DE (EUCTR) | 19/03/2012 | 20/12/2011 | Study of the Safety of Aztreonam for Inhalation in Children with Cystic Fibrosis and Chronic Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways - PALS (Pediatric Aztreonam Lysine Safety) | cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | France;United States;Spain;Poland;Germany;Italy | ||
| 38 | EUCTR2011-001255-36-NL (EUCTR) | 13/03/2012 | 19/10/2011 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 2 | United States;France;Spain;Poland;Belgium;Ireland;Austria;Germany;Netherlands;Italy | ||
| 39 | EUCTR2011-001362-18-IT (EUCTR) | 08/02/2012 | 22/02/2012 | Study of the Safety of Aztreonam for Inhalation in Children with Cystic Fibrosis and Chronic Infection of the Airways by Pseudomonas aeruginosa bacteria. | Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways. - PALS (Pediatric Aztreonam Lysine Safety) | Cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa. MedDRA version: 14.1;Level: SOC;Classification code 10021881;Term: Infections and infestations;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: PT;Classification code 10056971;Term: Infective exacerbation of chronic obstructive airways disease;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: CAYSTON aztreonam 75 mg powder and solvent for nebuliser solution INN or Proposed INN: AZTREONAM Other descriptive name: NA | GILEAD SCIENCES INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | Germany;Spain;Italy;United States | ||
| 40 | EUCTR2011-000801-39-SE (EUCTR) | 08/02/2012 | 13/12/2011 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 14.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | EUCTR2011-001255-36-BE (EUCTR) | 07/02/2012 | 13/10/2011 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 2 | France;United States;Spain;Poland;Belgium;Ireland;Austria;Netherlands;Germany;Italy | ||
| 42 | EUCTR2011-001255-36-IE (EUCTR) | 06/02/2012 | 24/10/2011 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | France;United States;Belgium;Spain;Poland;Ireland;Austria;Netherlands;Germany;Italy | ||
| 43 | EUCTR2011-001255-36-IT (EUCTR) | 27/01/2012 | 28/09/2012 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Pediatric Patients with Cystic Fibrosis (CF) and New Onset Lower Respiratory Tract Culture Positive for Pseudomonas aeruginosa (PA) Aztreonam Lysine for Pseudomonas Infection Eradication (ALPINE)study - ALPINE | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 15.0;Level: PT;Classification code 10056971;Term: Infective exacerbation of chronic obstructive airways disease;System Organ Class: 10021881 - Infections and infestations MedDRA version: 15.0;Level: SOC;Classification code 10021881;Term: Infections and infestations;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Aztreonam 75 mg powder and solvent for nebuliser solution INN or Proposed INN: AZTREONAM | GILEAD SCIENCES INC. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;Spain;Ireland;Austria;Netherlands;Germany;Italy | ||
| 44 | EUCTR2011-001362-18-ES (EUCTR) | 25/01/2012 | 21/12/2011 | Study of the Safety of Aztreonam for Inhalation in Children with Cystic Fibrosis and Chronic Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mgPowder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways - PALS (Pediatric Aztreonam Lysine Safety) | Cystic fibrosis and chronic infection of lower respiratory tract withPseudomonas aeruginosa MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam solución para inhalación Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | Germany;France;Spain;Italy;United States;Poland | ||
| 45 | EUCTR2011-001255-36-DE (EUCTR) | 16/01/2012 | 11/10/2011 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 2 | United States;France;Spain;Poland;Belgium;Ireland;Austria;Netherlands;Germany;Italy | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 46 | NCT01731015 (ClinicalTrials.gov) | January 2012 | 16/11/2012 | Imaging Lung Function Using Oxygen Enhanced MRI | A Pilot Study for Evaluation of Regional Lung Function in Normal Subjects and Subjects With Airway and Lung Disorders Using 1H Magnetic Resonance Imaging With Oxygen as a Contrast Agent | COPD;Asthma;Cystic Fibrosis;Emphysema;Small Airways Disease | Drug: Medical Grade Oxygen | Hal C Charles | NULL | Completed | 18 Years | 90 Years | Both | 15 | Phase 1 | United States |
| 47 | NCT01404234 (ClinicalTrials.gov) | December 2011 | 26/7/2011 | Safety of AZLI in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa in the Lower Airways | Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa (PA) in the Lower Airways | Cystic Fibrosis;Pseudomonas Aeruginosa | Drug: AZLI | Gilead Sciences | NULL | Completed | N/A | 12 Years | All | 61 | Phase 3 | United States;France;Germany;Italy;Poland;Spain |
| 48 | EUCTR2011-001255-36-ES (EUCTR) | 23/11/2011 | 18/10/2011 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) | Cystic fibrosis and new onset lower respiratory tract culture positive for P.aeruginosa. MedDRA version: 14.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | Germany;Netherlands;Belgium;France;Ireland;Spain;Italy;United States;Poland;Austria | ||
| 49 | EUCTR2011-000801-39-DE (EUCTR) | 31/08/2011 | 04/04/2011 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 17.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | ||
| 50 | NCT02782312 (ClinicalTrials.gov) | June 2011 | 17/5/2016 | Salmeterol-Fluticasone Combined Inhaled Therapy for Non-cystic Fibrosis Bronchiectasis | Salmeterol-Fluticasone Combined Inhaled Therapy for Non-cystic Fibrosis Bronchiectasis With Airway Limitation: a Prospective Study | Bronchiectasis | Drug: ICS+LABA;Other: routine therapy | Shanghai Pulmonary Hospital, Shanghai, China | NULL | Completed | 18 Years | N/A | Both | 120 | Phase 4 | China |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 51 | NCT01314716 (ClinicalTrials.gov) | April 2011 | 11/3/2011 | Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis | A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution/Aztreonam 75 mg Powder and Solvent for Nebuliser Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX2) | Bronchiectasis | Drug: AZLI;Drug: Placebo | Gilead Sciences | NULL | Completed | 18 Years | N/A | All | 274 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom |
| 52 | NCT01035853 (ClinicalTrials.gov) | December 2009 | 17/12/2009 | Sino-nasal Inhalation of Colistin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization | Sino-nasal Inhalation of Colistin Via the Pari Sinus Nebulizer in Patients With Cystic Fibrosis and Colonization of the Upper Airways With Pseudomonas Aeruginosa | Cystic Fibrosis;Pseudomonas Aeruginosa | Drug: Colistin | University of Jena | NULL | Completed | 6 Years | N/A | Both | 10 | Phase 2 | Germany |
| 53 | NCT00999531 (ClinicalTrials.gov) | October 2009 | 20/10/2009 | A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Trial of GS-9411 in Healthy Volunteers | A Phase 1, Randomized, Double-Blind, Placebo-Controlled Multiple Dose Trial to Assess the Safety, Tolerability, and Pharmacokinetics of GS-9411 in Healthy Volunteers | Cystic Fibrosis;Mucociliary Clearance;Airway Hydration | Drug: GS-9411;Drug: Placebo | Gilead Sciences | NULL | Completed | 18 Years | 65 Years | Both | 24 | Phase 1 | Australia |
| 54 | NCT01710449 (ClinicalTrials.gov) | September 2009 | 17/10/2012 | Evaluation of Regional Ventilation Using 19F MRI of Inert Perfluorinated Gases Mixed With Oxygen | Evaluation of Regional Ventilation in Normal Subjects and Subjects With Airway and Lung Disorders (COPD, Asthma, Emphysema, Small Airway Disease and Cystic Fibrosis) Using 19F MRI of Inert Perfluorinated Gases Mixed With Oxygen. | COPD;Asthma;Cystic Fibrosis;Emphysema;Small Airways Diseases | Drug: perfluorinated gas/oxygen mixture | Hal C Charles | NULL | Completed | 18 Years | N/A | Both | 44 | Phase 1 | United States |
| 55 | NCT00951522 (ClinicalTrials.gov) | September 2009 | 3/8/2009 | A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of GS-9411 in Healthy Male Volunteers | A Phase 1 Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability, and Pharmacokinetics of GS-9411 in Healthy Male Volunteers | Cystic Fibrosis;Mucociliary Clearance;Airway Hydration | Drug: GS-9411;Drug: Placebo | Gilead Sciences | NULL | Completed | 18 Years | 45 Years | Male | 15 | Phase 1 | Australia |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 56 | NCT00989807 (ClinicalTrials.gov) | September 2009 | 2/10/2009 | Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis | Expanded Access for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection Who Have Limited Treatment Options and Are at Risk for Disease Progression | Cystic Fibrosis;Pseudomonas Aeruginosa | Drug: Aztreonam lysine | Gilead Sciences | NULL | Approved for marketing | 6 Years | N/A | Both | N/A | Canada | |
| 57 | EUCTR2008-007877-19-DE (EUCTR) | 15/06/2009 | 28/05/2009 | Nasale Inhalation von Colistin mit dem Pari-Sinus-Vernebler bei Patienten mit Mukoviszidose und Pseudomonasnachweis im Nasen-Nasennebenhöhlenbereich.Nasal inhalation of colistin by the Pari Sinus nebulizer im patients with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways. - colistin nasal CF pilot | Nasale Inhalation von Colistin mit dem Pari-Sinus-Vernebler bei Patienten mit Mukoviszidose und Pseudomonasnachweis im Nasen-Nasennebenhöhlenbereich.Nasal inhalation of colistin by the Pari Sinus nebulizer im patients with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways. - colistin nasal CF pilot | subjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Colistin CF Product Name: Colistin CF INN or Proposed INN: Colistimethat-Natrium | University of Jena | NULL | Not Recruiting | Female: yes Male: yes | 14 | Germany | |||
| 58 | EUCTR2006-003275-12-NO (EUCTR) | 03/06/2009 | 27/03/2009 | Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa. MedDRA version: 8.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Trade Name: Zitromax Product Name: Zitromax Product Code: Zitromax INN or Proposed INN: AZITHROMYCIN Trade Name: Zitromax Product Name: zitromax Product Code: zitromax INN or Proposed INN: AZITHROMYCIN | Copenhagen CF-centre | NULL | NA | Female: yes Male: yes | 250 | Phase 4 | Denmark;Norway;Sweden | ||
| 59 | ChiCTR-TRC-13003979 | 2009-05-07 | 2013-10-28 | Application of roxithromycin in patients with bronchiectasis in stable condition | Effect of low-dose, long-term roxithromycin on airway imflammation and remodeling of stable non-cystic fibrosis bronchiectasis | Bronchietasis | Roxithromycin group:The patients received oral roxithromycin in roxithromycin group;Control group:The patients received no drug in control group; | First Affiliated Hospital of Guangxi Medical University | NULL | Completed | 18 | 70 | Both | Roxithromycin group:26;Control group:26; | China | |
| 60 | NCT00774072 (ClinicalTrials.gov) | October 2008 | 16/10/2008 | Nasal Inhalation of Tobramycin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization | Nasal Inhalation of Tobramycin by the Pari Sinus Nebulizer in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization in the Upper Airways | Cystic Fibrosis;Pseudomonas Aeruginosa | Drug: Tobramycin (Gernebcin®) | University of Jena | NULL | Completed | 8 Years | N/A | Both | 9 | Phase 2 | Germany |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 61 | NCT00630812 (ClinicalTrials.gov) | September 2008 | 27/2/2008 | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis- A Safety and Efficacy Study | Cystic Fibrosis | Drug: inhaled mannitol;Drug: Placebo comparator | Pharmaxis | ethica Clinical Research Inc.;Europe: KasaConsult bvba, Hoegaarden, Belgium;Argentina: Resolution Latin America; Buenos Aires, Argentina | Completed | 6 Years | N/A | All | 318 | Phase 3 | United States;Argentina;Belgium;Canada;France;Germany;Netherlands |
| 62 | EUCTR2008-000164-17-DE (EUCTR) | 13/08/2008 | 26/05/2008 | Nasale Inhalation von Tobramycin mit dem Pari Sinus-Vernebler bei Patienten mit Mukoviszidose und Pseudomonasnachweis im Nasen-Nasennebenhöhlenbereich.Nasal inhalation of tobramycin by the Pari Sinus nebulizer in patients with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways. - tobra nasal CF pilot | Nasale Inhalation von Tobramycin mit dem Pari Sinus-Vernebler bei Patienten mit Mukoviszidose und Pseudomonasnachweis im Nasen-Nasennebenhöhlenbereich.Nasal inhalation of tobramycin by the Pari Sinus nebulizer in patients with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways. - tobra nasal CF pilot | subjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways | Trade Name: Gernebcin 80 mg Product Name: Gernebcin 80 mg INN or Proposed INN: tobramycin | University of Jena | NULL | Not Recruiting | Female: yes Male: yes | 14 | Germany | |||
| 63 | NCT00712166 (ClinicalTrials.gov) | May 2008 | 7/7/2008 | Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa | A Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine For Inhalation in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa (AIR-CF4) | Cystic Fibrosis;Lung Infection;Pseudomonas Aeruginosa | Drug: AZLI 75 mg three times daily (TID);Drug: Placebo three times daily (TID) | Gilead Sciences | NULL | Completed | 6 Years | N/A | All | 160 | Phase 3 | United States;Australia;Canada |
| 64 | NCT00700050 (ClinicalTrials.gov) | April 2008 | 16/6/2008 | Modulation by Sex Hormones of Inflammation and Susceptibility to Pseudomonas Aeruginosa in Cystic Fibrosis Airways | Modulation by Sex Hormones of Inflammation and Susceptibility to Pseudomonas Aeruginosa in Cystic Fibrosis Airways - A Pilot Study | Cystic Fibrosis | Drug: Hypertonic saline | The Hospital for Sick Children | NULL | Recruiting | N/A | 22 Years | Both | 32 | Phase 3 | Canada |
| 65 | NCT00541190 (ClinicalTrials.gov) | October 2007 | 5/10/2007 | Absorptive Clearance in the Cystic Fibrosis Airway | Absorptive Clearance in the Cystic Fibrosis Airway | Cystic Fibrosis | Other: Technetium [Tc-99m] sulfur colloid and Indium [In-111] DTPA | University of Pittsburgh | NULL | Completed | 18 Years | N/A | All | 21 | N/A | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 66 | EUCTR2006-003275-12-DK (EUCTR) | 23/05/2007 | 17/04/2007 | Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa. MedDRA version: 8.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Trade Name: Zitromax Product Name: zitromax Product Code: zitromax INN or Proposed INN: AZITHROMYCIN Trade Name: Zitromax Product Name: zitromax Product Code: zitromax INN or Proposed INN: AZITHROMYCIN | Copenhagen CF-centre | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 4 | Denmark | ||
| 67 | NCT00721071 (ClinicalTrials.gov) | December 2006 | 21/7/2008 | Utility of Induced Sputum Using Hypertonic Saline to Evaluate Infection and Inflammation in Cystic Fibrosis | Diagnostic Utility of Induced Sputum Using Hypertonic Saline to Evaluate Airway Infection and Inflammation in Cystic Fibrosis | Cystic Fibrosis | Drug: Hypertonic Saline | The Hospital for Sick Children | NULL | Completed | 6 Years | 18 Years | Both | 95 | Phase 2 | Canada |
| 68 | EUCTR2005-003870-88-DE (EUCTR) | 20/10/2006 | 28/08/2006 | Randomized, placebo-controlled, double-blind study to investigate the efficacy and safety of a 24-week inhalation treatment with glutathione in cystic fibrosis patients - GSH-4 | Randomized, placebo-controlled, double-blind study to investigate the efficacy and safety of a 24-week inhalation treatment with glutathione in cystic fibrosis patients - GSH-4 | Cystic fibrosis (CF) is the most common autosomal recessive lethal hereditary disorder in Caucasians. The majority of cystic fibrosis patients die as a result of progressive pulmonary disease. Airway inflammation, characterized by an excessive and persistent neutrophilic infiltration, is key for the pathogenesis of CF lung disease, and ultimately leads to lung destruction. | Product Name: GSH (Glutathione) Product Code: TAD 600 INN or Proposed INN: Glutathione Other descriptive name: reduced glutathione | Mukoviszidose Institut gGmbH i. G. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Germany | |||
| 69 | NCT01463371 (ClinicalTrials.gov) | October 2006 | 28/10/2011 | Effects of Azithromycin on Airway Oxidative Stress Markers in Patients With Bronchiectasis | Effects of Long-Term Azithromycin Treatment on Airway Oxidative Stress Markers in Patients With Stable Non-Cystic Fibrosis Bronchiectasis | Bronchiectasis | Drug: Azithromycin | Instituto de Investigacion Sanitaria La Fe | Sociedad Valenciana de Neumología | Completed | 16 Years | 80 Years | Both | 30 | N/A | Spain |
| 70 | NCT00128492 (ClinicalTrials.gov) | August 2005 | 8/8/2005 | Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA) | A Phase 3, Open-label, Follow-On Study of Multiple Courses of Aztreonam Lysinate for Inhalation (AI) in Cystic Fibrosis Patients (AIR-CF3) | Cystic Fibrosis | Drug: AZLI 75 mg two times a day (BID)/ three times a day (TID) | Gilead Sciences | NULL | Completed | 6 Years | N/A | All | 274 | Phase 3 | United States;Australia;Canada;New Zealand |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 71 | NCT00112359 (ClinicalTrials.gov) | May 2005 | 1/6/2005 | International Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa | A Phase 3, Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary Pseudomonas Aeruginosa (AIR-CF1) | Cystic Fibrosis | Drug: AZLI 75 mg three times a day (TID);Drug: Placebo three times a day (TID) | Gilead Sciences | NULL | Completed | 6 Years | N/A | All | 166 | Phase 3 | United States;Australia;Canada;New Zealand |
| 72 | NCT00104520 (ClinicalTrials.gov) | February 2005 | 1/3/2005 | Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa | A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary P. Aeruginosa Requiring Frequent Antibiotics (AIR-CF2) | Cystic Fibrosis | Drug: AZLI 75 mg two times a day (BID)/three times a day (TID);Drug: Placebo two times a day (BID)/three times a day (TID) | Gilead Sciences | NULL | Completed | 6 Years | N/A | All | 211 | Phase 3 | United States |
| 73 | NCT00097773 (ClinicalTrials.gov) | September 2004 | 30/11/2004 | Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic Fibrosis | Effectiveness and Safety of Intermittent Antimicrobial Therapy for the Treatment of New Onset Pseudomonas Aeruginosa Airway Infection in Young Patients With Cystic Fibrosis | Cystic Fibrosis;Pulmonary Disease, Chronic Obstructive | Drug: Tobramycin solution for inhalation (TOBI);Drug: Oral placebo;Drug: Oral ciprofloxacin | Seattle Children's Hospital | National Heart, Lung, and Blood Institute (NHLBI);Cystic Fibrosis Foundation Therapeutics;CF Therapeutics Development Network Coordinating Center | Completed | 1 Year | 12 Years | All | 304 | Phase 2 | United States |
| 74 | NCT00255242 (ClinicalTrials.gov) | July 2004 | 16/11/2005 | Effect of Simvastatin on CF Airway Inflammation | Effect of Simvastatin on CF Airway Inflammation | Cystic Fibrosis | Drug: Simvastatin treatment for 28 days | Akron Children's Hospital | Cystic Fibrosis Foundation Therapeutics | Completed | 10 Years | N/A | Both | 40 | Phase 1 | United States |
| 75 | NCT02010411 (ClinicalTrials.gov) | June 2004 | 9/12/2013 | Alpha1 Antitrypsin Aerosol Therapy in Cystic Fibrosis | Effects of Prolastin Aerosol Therapy on Bacterial Density in the Airways of Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Prolastin (drug) | Université de Sherbrooke | NULL | Terminated | 14 Years | N/A | Both | 17 | Phase 2 | Canada |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 76 | NCT00499720 (ClinicalTrials.gov) | October 2003 | 9/7/2007 | Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection | Expanded Access Program for Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection Who Have Limited Treatment Options and Are at Risk for Disease Progression | Cystic Fibrosis;Pseudomonas Aeruginosa Airway Infection | Drug: Aztreonam Lysine for Inhalation | Gilead Sciences | NULL | Approved for marketing | 6 Years | N/A | Both | N/A | United States;Puerto Rico | |
| 77 | NCT00164021 (ClinicalTrials.gov) | February 2001 | 13/9/2005 | The Prevalence and Significance of Gastro-oesophageal Reflux in Cystic Fibrosis Before and After Lung Transplantation | The Prevalence and Significance of Gastro-oesophageal Reflux in Adults With Cystic Fibrosis Before and After Lung Transplantation, Together With the Effects of Physiotherapy Airway Clearance Techniques on Gastro-oesophageal Function | Cystic Fibrosis | Procedure: Physiotherapy, exercise, percutaneous gastrostomy feeds;Drug: Anti-reflux pharmacotherapy | Bayside Health | The Alfred;Monash University | Recruiting | 16 Years | 70 Years | Both | 180 | N/A | Australia |
| 78 | EUCTR2006-003275-12-SE (EUCTR) | 07/07/2009 | Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa. MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Trade Name: Azithromycin Product Name: azithromycin Product Code: azithromycin INN or Proposed INN: AZITHROMYCIN Trade Name: Zitromax Product Name: zitromax Product Code: zitromax INN or Proposed INN: AZITHROMYCIN | Copenhagen CF-centre | NULL | NA | Female: yes Male: yes | 250 | Phase 4 | Denmark;Norway;Sweden | |||
| 79 | EUCTR2011-001255-36-Outside-EU/EEA (EUCTR) | 02/02/2015 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A | Gilead Sciences, Inc. | NULL | NA | Female: yes Male: yes | 105 | Phase 2 | United States | |||
| 80 | EUCTR2011-001255-36-FR (EUCTR) | 14/10/2011 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 14.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A | Gilead Sciences, Inc. | NULL | NA | Female: yes Male: yes | 80 | Phase 2 | United States;France;Belgium;Spain;Poland;Ireland;Austria;Netherlands;Germany;Italy | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 81 | EUCTR2015-000396-26-Outside-EU/EEA (EUCTR) | 02/02/2015 | Program to Give the Drug Aztreonam Lysine for Inhalation to Patients with Cystic Fibrosis and infection by the Bacteria Pseudomonas aeruginosa Who Have Limited Treatment Options and are at Risk for Disease Progression | Expanded Access Program for Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis and Pseudomonas aeruginosa Airway Infection Who Have Limited Treatment Options and are at Risk for Disease Progression | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | NA | Female: yes Male: yes | 603 | United States | ||||
| 82 | EUCTR2016-002749-42-IE (EUCTR) | 26/07/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 20.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands | ||||
| 83 | EUCTR2015-000397-36-Outside-EU/EEA (EUCTR) | 03/02/2015 | Program to Give the Drug Aztreonamn Lysine for Inhalation to Canadian Patients with Cystic Fibrosis and infection by the Bacteria Pseudomonas aeruginosa Who Have Limited Treatment Options and are at Risk for Disease Progression | Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients with Cystic Fibrosis and Pseudomonas aeruginosa Airway Infection Who Have Limited Treatment Options and are at Risk for Disease Progression | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | NA | Female: yes Male: yes | 45 | Canada | ||||
| 84 | EUCTR2020-001762-11-DE (EUCTR) | 17/09/2020 | A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial. | An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials | Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2;Phase 3 | Serbia;Portugal;United States;Slovakia;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden | |||
| 85 | EUCTR2020-001762-11-SE (EUCTR) | 17/07/2020 | A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial. | An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials | Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2;Phase 3 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 86 | EUCTR2020-001762-11-AT (EUCTR) | 10/08/2020 | A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial. | An Observational Long-Term Safety Surveillance Study of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials | Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2;Phase 3 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | |||
| 87 | EUCTR2009-011740-19-Outside-EU/EEA (EUCTR) | 02/02/2015 | Clinical Trial to Assess the Safety and Efficacy of Aztreonam for Inhalation Solution (AZLI) in patients with Cystic Fibrosis (CF) and Chronic Burkholderia Species Infection | Phase 3b Randomized, Double-Blind, Placebo-Controlled Two-Part Trial to Assess the Safety and Efficacy of Continuous Aztreonam for Inhalation Solution (AZLI) in Subjects with Cystic Fibrosis (CF) and Chronic Burkholderia Species Infection | Cystic Fibrosis subjects with chronic Burkholderia spp. infection of the airways. MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston INN or Proposed INN: AZTREONAM Other descriptive name: N/A | Gilead Sciences, Inc. | NULL | NA | Female: yes Male: yes | 100 | Phase 3b | United States;Canada | |||
| 88 | EUCTR2011-001362-18-Outside-EU/EEA (EUCTR) | 02/02/2015 | Study of the Safety of Aztreonam for Inhalation in Children with Cystic Fibrosis and Chronic Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways - PALS (Pediatric Aztreonam Lysine Safety) | cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | United States | |||
| 89 | EUCTR2015-000395-97-Outside-EU/EEA (EUCTR) | 02/02/2015 | A Clinical Trial to Evaluate the Effects of the drug Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis, Mild Lung Disease, and infection with the bacteria Pseudomonas aeruginosa (AIR-CF4) | A Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis, Mild Lung Disease, and P. aeruginosa (AIR-CF4) | Cystic Fibrosis with Mild Lung Disease and P. aeruginosa (AIR-CF4);Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | Gilead Sciences Pty Ltd;Gilead Sciences Canada, Inc. | NA | Female: yes Male: yes | 157 | United States;Australia;Canada | ||||
| 90 | EUCTR2011-001362-18-FR (EUCTR) | 05/01/2012 | Study of the Safety of Aztreonam for Inhalation in Children with Cystic Fibrosis and Chronic Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways - PALS (Pediatric Aztreonam Lysine Safety) | cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | United States;France;Spain;Poland;Germany;Italy |