299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details
臨床試験数 : 1,696 / 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170
| 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 | 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: 22.1;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 | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Netherlands;Germany | ||
| 2 | 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 | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands | ||
| 3 | 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 | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands | ||
| 4 | EUCTR2016-002749-42-FR (EUCTR) | 12/12/2017 | 01/08/2017 | 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 | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands | ||
| 5 | NCT03219164 (ClinicalTrials.gov) | November 28, 2017 | 13/7/2017 | Safety and Efficacy of 2 Treatment Regimens of Aztreonam for Inhalation Solution in Children With Cystic Fibrosis and New Onset Pseudomonas Aeruginosa Infection | 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 | Pseudomonas Aeruginosa Respiratory Tract Infection;Cystic Fibrosis | Drug: AZLI;Drug: Placebo | Gilead Sciences | NULL | Completed | 3 Months | 18 Years | All | 149 | Phase 3 | United Kingdom;Austria;Belgium;Denmark;France;Germany;Greece;Israel;Italy;Netherlands;Spain;United States |
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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: 22.1;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 | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands | ||
| 9 | 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 | Not Recruiting | 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-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 | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands | ||
| 11 | 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 | ||
| 12 | NCT02894684 (ClinicalTrials.gov) | January 2017 | 1/9/2016 | Aztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic Fibrosis | Aztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic Fibrosis. An Randomised, Crossover Pilot Study of AZLI Plus Intravenous Colistin® Versus Standard Dual Intravenous Therapy | Cystic Fibrosis;Infection;Pseudomonas | Drug: Aztreonam;Drug: Standard Care | Liverpool Heart and Chest Hospital NHS Foundation Trust | University of Liverpool | Completed | 16 Years | 65 Years | Male | 16 | Phase 4 | United Kingdom |
| 13 | NCT01641822 (ClinicalTrials.gov) | December 2012 | 13/7/2012 | Phase 3 Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy Regimen for the Treatment of Chronic Pseudomonas Aeruginosa Infection in Patients With CF | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy (CAT) Regimen of Inhaled Antibiotics for the Treatment of Chronic Pulmonary Pseudomonas Aeruginosa Infection in Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: AZLI;Drug: Placebo to match AZLI;Drug: Tobramycin inhalation solution | Gilead Sciences | NULL | Completed | 6 Years | N/A | All | 107 | Phase 3 | United States |
| 14 | NCT01375049 (ClinicalTrials.gov) | August 2011 | 15/6/2011 | Aztreonam Lysine for Pseudomonas Infection Eradication Study | 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) | Cystic Fibrosis | Drug: Aztreonam for Inhalation Solution (AZLI) | Gilead Sciences | NULL | Completed | 3 Months | 17 Years | All | 105 | Phase 2 | Italy;Netherlands;Poland;Spain;Austria;Belgium;France;Germany;United States;Ireland |
| 15 | NCT01059565 (ClinicalTrials.gov) | February 2010 | 28/1/2010 | Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis 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;Burkholderia Infections | Drug: AZLI;Drug: Placebo | Gilead Sciences | NULL | Completed | 6 Years | N/A | All | 102 | Phase 3 | United States;Canada |
| 16 | NCT00757237 (ClinicalTrials.gov) | August 2008 | 22/9/2008 | Aztreonam for Inhalation Solution vs Tobramycin Inhalation Solution in Patients With Cystic Fibrosis & Pseudomonas Aeruginosa | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam for Inhalation Solution (AZLI) Versus Tobramycin Inhalation Solution (TIS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects With Cystic Fibrosis Followed by an Open-Label, Single Arm Extension (European Union [EU] Only) | Cystic Fibrosis | Drug: Aztreonam for Inhalation Solution (AZLI);Drug: Tobramycin Inhalation Solution (TIS) | Gilead Sciences | Chiltern International Inc.;ClinPhone, Inc.;Covance | Completed | 6 Years | N/A | All | 274 | Phase 3 | United States;Austria;Belgium;Denmark;France;Germany;Ireland;Italy;Netherlands;Portugal;Spain;Switzerland;United Kingdom;Poland |
| 17 | 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 |
| 18 | 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 |
| 19 | 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 |
| 20 | 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 |
| 21 | 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 3 | United States;Canada | |||
| 22 | EUCTR2015-000398-11-Outside-EU/EEA (EUCTR) | 03/02/2015 | A Clinical Trial to Assess the Safety and Efficacy of an Alternating Therapy of Antibiotics with the Drug Aztreonam for Inhalation Solution (AZLI) for the Treatment of Lung Infection by the bacteria Pseudomonas aeruginosa in Patients with Cystic Fibrosis. | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy (CAT) Regimen of Inhaled Antibiotics for the Treatment of Chronic Pulmonary Pseudomonas aeruginosa Infection in Subjects with Cystic Fibrosis | 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 INN or Proposed INN: AZTREONAM Trade Name: TOBI® INN or Proposed INN: TOBRAMYCIN Other descriptive name: TOBRAMYCIN | Gilead Sciences, Inc. | NULL | NA | Female: yes Male: yes | 250 | Phase 3 | United States | |||
| 23 | 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] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands |