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 | NCT03894657 (ClinicalTrials.gov) | December 18, 2019 | 12/2/2019 | Validation of Respiratory Epithelial Functional Assessment to Predict Clinical Efficacy of Orkambi®. | Validation of Respiratory Epithelial Functional Assessment to Predict Clinical Efficacy of Orkambi®. Pathway to Personalized Therapy in Cystic Fibrosis | Cystic Fibrosis;Homozygous F508del Mutation | Diagnostic Test: Nasal brushing;Other: Sputum sample;Other: blood sample;Drug: Orkambi | Assistance Publique - Hôpitaux de Paris | NULL | Recruiting | 5 Years | N/A | All | 104 | N/A | France |
| 2 | EUCTR2016-000398-19-BE (EUCTR) | 08/03/2016 | 09/02/2016 | Pilot study: pharmacokinetics of beta-lactam antibiotics, piperacillin-tazobactam, ceftazidim and meropenem in blood and sputum of cystic fibrosis patients. | Pilot study: pharmacokinetics of beta-lactam antibiotics, piperacillin-tazobactam, ceftazidim and meropenem in blood and sputum of cystic fibrosis patients. - pharmacokinetics of beta-lactam antibiotics, piperacillin-tazobactam, ceftazidim and meropenem | Cystic fibrosis;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Meropenem Fresenius Kabi 1 g poeder voor oplossing voor injectie of infusie INN or Proposed INN: Meropenem Fresenius Kabi Other descriptive name: MEROPENEM TRIHYDRATE Trade Name: Ceftazidim Fresenius Kabi 2000 mg poeder voor oplossing voor injectie of infusie INN or Proposed INN: Ceftazidim Fresenius Kabi Other descriptive name: CEFTAZIDIME PENTAHYDRATE Trade Name: Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie Other descriptive name: PIPERACILLIN SODIUM INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie Other descriptive name: TAZOBACTAM SODIUM Trade Name: Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie Other descriptive name: PIPERACILLIN SODIUM INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie Other descriptive name: TAZOBACTAM SODIUM | Ghent University | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 4 | Belgium | ||
| 3 | NCT02840136 (ClinicalTrials.gov) | February 2016 | 18/7/2016 | LC-MS/MS Based Method Development for the Monitoring of Antibiotic Concentrations in Sputum of Cystic Fibrosis Patients | Optimisation, Valorisation and Application of UPLC-MS/MS Based Monitoring of Antibiotic Concentrations in Sputum of Cystic Fibrosis Patients - Part 3: Non-blank Sputum Samples for Method Optimisation and Validation | Cystic Fibrosis | Drug: Piperacillin-tazobactam combination product;Drug: Meropenem;Drug: Ceftazidime | University Ghent | King Baudouin Foundation;Belgische Vereniging voor Strijd tegen Mucoviscidose | Suspended | 12 Years | N/A | All | 40 | N/A | Belgium |
| 4 | NCT02589444 (ClinicalTrials.gov) | December 2015 | 20/10/2015 | Vitamin D and Microbiota in Cystic Fibrosis | Pilot Study Evaluating the Role of Vitamin D Repletion on Gut and Lung Microbiota in Cystic Fibrosis | Vitamin D Deficiency;Cystic Fibrosis | Dietary Supplement: High-Dose Vitamin D3;Other: Stool Sample;Other: Sputum Sample;Other: Sham Comparator;Procedure: Blood draw | Emory University | NULL | Completed | 18 Years | N/A | All | 41 | N/A | United States |
| 5 | EUCTR2015-003662-87-DK (EUCTR) | 13/11/2015 | 22/09/2015 | Pseudomonas Aeruginosa - Inhalation treatment, biomarkers and quality of life | Pseudomonas Aeruginosa - Inhalation treatment, biomarkers and quality of life - Pseudomonas, Tazocin or Colistin | Chronic pulmonary disease patients, except cystic fibrosis patients, with confirmed pulmonary infection by sputum sample positive for Pseudomonas Aeruginosa. MedDRA version: 18.1;Level: LLT;Classification code 10051190;Term: Pneumonia Pseudomonas aeruginosa;System Organ Class: 100000004862 MedDRA version: 18.1;Classification code 10050700;Term: Chronic respiratory disease NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: colistimethate sodium (promixin) INN or Proposed INN: COLISTIMETHATE SODIUM Trade Name: Piperacillin with Tazobactam (tazocin) INN or Proposed INN: PIPERACILLIN Other descriptive name: PIPERACILLIN INN or Proposed INN: TAZOBACTAM Other descriptive name: TAZOBACTAM | Aarhus University Hospital, Department of Respiratory Medicine | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Denmark | |||
| 6 | NCT02444234 (ClinicalTrials.gov) | July 2015 | 6/5/2015 | Pharmacokinetics of Tedizolid Phosphate in Cystic Fibrosis | Steady-State Pharmacokinetics of Tedizolid in Plasma and Sputum of Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Tedizolid PO;Drug: Tedizolid IV | University of Southern California | Merck Sharp & Dohme Corp. | Completed | 18 Years | N/A | All | 11 | Phase 4 | United States |
| 7 | EUCTR2013-004987-80-BE (EUCTR) | 28/08/2014 | 18/02/2014 | Colistin dosage through blood samples and sputum in Cystic Fibrosis (CF) population | Colistin use in Cystic Fibrosis patients: pharmacokinetic studies (intravenous administration) in relation with pharmacodynamics, tolerance profile and risk of selection of resistance. | Colistin use in Cystic Fibrosis patients MedDRA version: 16.1;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: COLISTINEB 2MUI INN or Proposed INN: Colistineb Other descriptive name: COLISTIMETHATE SODIUM (A COMPONENT) | CUB - Hôpital Erasme | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Belgium | ||||
| 8 | NCT01576315 (ClinicalTrials.gov) | June 2014 | 29/3/2012 | ATCF (Azole Therapy in Cystic Fibrosis) | Efficacy of Itraconazole and of Voriconazole in Patients With Cystic Fibrosis and Presenting With Persistent Positive Sputums for Aspergillus. | Cystic Fibrosis;Aspergillus Infections | Drug: Itraconazole/voriconazole | Rennes University Hospital | NULL | Completed | 12 Years | N/A | Both | 11 | Phase 2 | France;United Kingdom |
| 9 | EUCTR2011-005799-41-GB (EUCTR) | 04/10/2012 | 21/08/2012 | Azole Therapy in Cystic Fibrosis (ATCF) | Azole Therapy in Cystic Fibrosis (ATCF) : Efficacy of itraconazole and ofvoriconazole in patients with cystic fibrosis and presenting withpersistent positive sputums for Aspergillus - Azole Therapy in Cystic Fibrosis (ATCF) | Cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Level: HLT;Classification code 10003486;Term: Aspergillus infections;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: SPORANOX Product Name: Sporanox 10 mg/ml Oral Solution INN or Proposed INN: ITRACONAZOLE Other descriptive name: SPORANOX Trade Name: V-Fend Product Name: VFEND 40 mg/ml powder for oral suspension INN or Proposed INN: voriconazole Other descriptive name: Vfend | CHU de Rennes (Rennes University Hospital Centre) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | United Kingdom | |||
| 10 | NCT01201434 (ClinicalTrials.gov) | October 2010 | 31/8/2010 | Effect of Probiotics on Sputum Inflammation and Pulmonary Infections in Patients With Cystic Fibrosis | The Effect of Probiotics on Sputum Bacteria, Sputum Inflammation, and Pulmonary Infections in Patients With Cystic Fibrosis: A Double-blind Placebo-controlled Trial | Cystic Fibrosis | Dietary Supplement: Bio-25 probiotic | Sheba Medical Center | NULL | Terminated | 5 Years | 40 Years | Both | 12 | N/A | NULL |
| 11 | NCT02198079 (ClinicalTrials.gov) | March 2010 | 21/2/2014 | A Prospective, Multicenter, Collaborative Study to Determine the Prevalence of Nontuberculous Mycobacteria (NTM) in Pediatric Patients With Cystic Fibrosis in Florida | A Prospective, Multicenter, Collaborative Study to Determine the Prevalence of Nontuberculous Mycobacteria (NTM) in Pediatric Patients With Cystic Fibrosis in Florida | Cystic Fibrosis;Pediatrics | Biological: Sputum | University of Miami | University of Florida | Completed | N/A | 18 Years | Both | 85 | N/A | United States |
| 12 | NCT00996424 (ClinicalTrials.gov) | January 2010 | 15/10/2009 | The Effect of Inhaled N-Acetylcysteine Compared to Normal Saline on Sputum Rheology and Lung Function | The Effect of Inhaled N-Acetylcysteine Compared to Normal Saline on Sputum Rheology and Lung Function. | Cystic Fibrosis | Drug: Acetylcysteine;Drug: normal saline | University Hospital, Ghent | BVSM | Terminated | 6 Years | 64 Years | Both | 19 | Phase 4 | Belgium |
| 13 | NCT01155115 (ClinicalTrials.gov) | January 2010 | 29/6/2010 | Inflammatory and Microbiologic Markers in Sputum: Comparing Cystic Fibrosis With Primary Ciliary Dyskinesia | Inflammatory and Microbiologic Markers in Sputum in Response to Pulmonary Exacerbation: Comparing Cystic Fibrosis With Primary Ciliary Dyskinesia | Cystic Fibrosis;Primary Ciliary Dyskinesia | Procedure: Sputum Collection;Procedure: Pulmonary Function Testing;Procedure: Exhaled Nitric Oxide | The Hospital for Sick Children | NULL | Completed | 6 Years | 18 Years | Both | 46 | N/A | Canada |
| 14 | EUCTR2008-008317-20-BE (EUCTR) | 13/11/2009 | 21/09/2009 | The effect of inhaled N-Acetylcysteine compared to normal saline on sputum rheology and lung function | The effect of inhaled N-Acetylcysteine compared to normal saline on sputum rheology and lung function | Cystic Fibrosis MedDRA version: 12.0;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Lysomucil 10 % Product Name: N-acetylcysteine INN or Proposed INN: Acetylcysteine | University Hospital Ghent | NULL | Not Recruiting | Female: yes Male: yes | Belgium | ||||
| 15 | NCT00843817 (ClinicalTrials.gov) | April 2009 | 12/2/2009 | RhDNase and Biodistribution of PMN Serine Proteases in Cystic Fibrosis Sputum | RhDNase Effect on Biodistribution of PMN Serine Proteases in Cystic Fibrosis Sputum | Cystic Fibrosis | Drug: Pulmozyme | University Hospital, Tours | NULL | Completed | 18 Years | N/A | All | 15 | Phase 4 | France |
| 16 | NCT01112059 (ClinicalTrials.gov) | November 2008 | 20/4/2010 | Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult Cystic Fibrosis (CF) Patients | A Randomized Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult CF Patients Hospitalized for Pulmonary Exacerbations | Cystic Fibrosis | Drug: Doxycycline;Other: placebo | University of Alabama at Birmingham | Cystic Fibrosis Foundation Therapeutics | Completed | 19 Years | N/A | All | 40 | N/A | United States |
| 17 | NCT01323101 (ClinicalTrials.gov) | April 2008 | 15/2/2011 | Doxycycline Effects on Inflammation in Cystic Fibrosis | Effect of Doxycycline on Sputum Biomarkers of Inflammation and Lung Epithelial Repair in Patients With Cystic Fibrosis. | Cystic Fibrosis | Drug: Doxycycline;Other: No doxycycline | University of Southern California | NULL | Completed | 18 Years | N/A | All | 21 | Phase 4 | United States |
| 18 | NCT00719381 (ClinicalTrials.gov) | January 2008 | 17/7/2008 | Effect of Pioglitazone on Inflammation in Cystic Fibrosis | Effect of Pioglitazone on Sputum Biomarkers of Inflammation and Lung Epithelial Repair in Cystic Fibrosis | Cystic Fibrosis | Drug: Pioglitazone | Paul Beringer | NULL | Completed | 18 Years | N/A | Both | 24 | Phase 1 | United States |
| 19 | EUCTR2007-002707-40-BE (EUCTR) | 28/06/2007 | 04/06/2007 | The effect of inhalation with hypertonic saline (7%) on lung function and sputum rheology in Cystic Fibrosis patients | The effect of inhalation with hypertonic saline (7%) on lung function and sputum rheology in Cystic Fibrosis patients | Mucoviscidose MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Hypertonic saline solution INN or Proposed INN: Sodium Chloride Product Name: Normal saline solution INN or Proposed INN: Sodium Chloride | University Hospital Ghent | NULL | Not Recruiting | Female: yes Male: yes | 60 | Belgium | |||
| 20 | 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 |
| 21 | NCT00219895 (ClinicalTrials.gov) | August 2004 | 16/9/2005 | Assessment of Inflammatory Mediators (AIM) | Assessment of Induced Sputum as a Tool to Evaluate Anti-Inflammatory Agents in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Ibuprofen | Ramsey, Bonnie, MD | Cystic Fibrosis Foundation Therapeutics | Completed | 10 Years | N/A | Both | 120 | N/A | United States |