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 | 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) | Completed | 6 Years | 21 Years | All | 20 | United States | |
| 2 | NCT03579173 (ClinicalTrials.gov) | May 8, 2018 | 25/6/2018 | Determinants of Early Cystic Fibrosis Lung Disease | Determinants of Early Cystic Fibrosis Lung Disease | Cystic Fibrosis in Children | Diagnostic Test: Infant PFT;Diagnostic Test: Lung Clearance Index;Diagnostic Test: Passive tidal breathing | Indiana University | NULL | Active, not recruiting | 1 Month | 5 Years | All | 55 | United States | |
| 3 | NCT02950116 (ClinicalTrials.gov) | March 9, 2017 | 11/10/2016 | Lung Clearance Index (LCI) in Pediatric Patients With Obstructive Lung Disease | Lung Clearance Index in Pediatric Patients With Obstructive Lung Disease | Asthma;Bronchiectasis;Cystic Fibrosis | Device: Perform three multiple breath nitrogen washout tests (N2-MBW-test) | Universitair Ziekenhuis Brussel | NULL | Terminated | 6 Years | 17 Years | All | 27 | N/A | Belgium |
| 4 | NCT03497117 (ClinicalTrials.gov) | August 25, 2015 | 29/3/2018 | 19F MRI of Ventilation in Subjects With Cystic Fibrosis Undergoing Treatment for Pulmonary Exacerbation | 19F Magnetic Resonance Imaging of Ventilation in Subjects With Cystic Fibrosis Undergoing Treatment for Pulmonary Exacerbation | Cystic Fibrosis | Device: Lung Clearance Index;Drug: MRI with PFP | University of North Carolina, Chapel Hill | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Terminated | 18 Years | 99 Years | All | 5 | Early Phase 1 | United States |
| 5 | NCT02740868 (ClinicalTrials.gov) | August 2015 | 19/8/2015 | Xenon-129 Lung Magnetic Resonance Imaging: Study of Healthy Volunteers and Participants With Pulmonary Disease | Development of Hyperpolarized Xenon-129 Lung Magnetic Resonance Imaging: Comparative Pilot Study of Healthy Volunteers and Participants With Pulmonary Disease | Cystic Fibrosis;Asthma | Drug: Xenon-129;Device: Magnetic Resonance Imaging;Device: Lung Clearance Index | The Hospital for Sick Children | NULL | Recruiting | 8 Years | N/A | All | 30 | Phase 2 | Canada |
| 6 | NCT02248922 (ClinicalTrials.gov) | January 27, 2015 | 22/9/2014 | Evaluation of Lung Clearance Index in Cystic Fibrosis (CF) Patients, Infected With P.Aeruginosa | An 8 Week Open-label Interventional Multicenter Study to Evaluate the Lung Clearance Index as Endpoint for Clinical Trials in Cystic Fibrosis Patients = 6 Years of Age, Chronically Infected With Pseudomonas Aeruginosa | Chronic Lung Infection With Pseudomonas Aeruginosa in Cystic Fibrosis | Drug: TIS or TIP | Novartis Pharmaceuticals | NULL | Terminated | 6 Years | N/A | All | 17 | Phase 4 | Germany |
| 7 | EUCTR2014-001204-21-DE (EUCTR) | 17/11/2014 | 22/08/2014 | An open-label clinical trial that evaluates the lung clearance index in cystic fibrosis patients = 6 years of age, chronically infected with Pseudomonas aeruginosa | An 8 week open-label interventional multicenter study to evaluate the lung clearance index as endpoint for clinical trials in cystic fibrosis patients = 6 years of age, chronically infected with Pseudomonas aeruginosa | Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosispatients MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 18.0;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: TOBI Podhaler Product Code: TBM100C INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Germany | |||
| 8 | EUCTR2013-004295-35-AT (EUCTR) | 30/04/2014 | 02/04/2014 | Lung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept study | Lung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept study - LCI-OUT | Chronic lung P. Aeruginosa Infection MedDRA version: 16.1;Level: PT;Classification code 10061229;Term: Lung infection;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler Product Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler INN or Proposed INN: aztreonam Other descriptive name: AZTREONAM LYSINE Trade Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel Product Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel INN or Proposed INN: COLISTIMETHATE SODIUM Trade Name: TOBI Product Name: Tobi INN or Proposed INN: TOBRAMYCIN SULFATE | Medical University Innsbruck - Department für Kinder- und Jugendheilkunde (Pädiatrie III) | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 4 | Austria | ||
| 9 | NCT02276898 (ClinicalTrials.gov) | November 2011 | 22/10/2014 | A Randomized-Controlled Trial of Inhaled Hypertonic Saline (7%) to Evaluate the Lung Clearance Index | A Randomized-Controlled Trial of Inhaled Hypertonic Saline (7%) to Evaluate the Lung Clearance Index as a Short-term Pharmacodynamic Biomarker in Patients With Cystic Fibrosis. | Cystic Fibrosis | Drug: Hypertonic Saline 7%;Drug: Isotonic Saline 0.9% (Placebo) | The Hospital for Sick Children | NULL | Completed | 6 Years | 18 Years | Both | 24 | Phase 2 | Canada |
| 10 | NCT01262352 (ClinicalTrials.gov) | January 2011 | 15/12/2010 | Study of the Effect of Ivacaftor on Lung Clearance Index in Subjects With Cystic Fibrosis and the G551D Mutation | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Effect of VX-770 on Lung Clearance Index in Subjects With Cystic Fibrosis, the G551D Mutation, and FEV1 >90% Predicted | Cystic Fibrosis | Drug: Ivacaftor;Drug: Placebo | Vertex Pharmaceuticals Incorporated | Cystic Fibrosis Foundation Therapeutics | Completed | 6 Years | N/A | All | 21 | Phase 2 | United States;Canada;United Kingdom;Ireland |
| 11 | EUCTR2010-020546-96-GB (EUCTR) | 08/10/2010 | 17/08/2010 | Study of the Effect of VX-770 on Lung Clearance Index in Subjects With Cystic Fibrosis and the G551D Mutation | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Effect of VX-770 on Lung Clearance Index in Subjects with Cystic Fibrosis, the G551D Mutation, and FEV1 >90% Predicted - | Cystic Fibrosis MedDRA version: 14.0;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] | Product Name: VX-770 Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Other descriptive name: VRT-813077 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 16 | Phase 2 | United Kingdom;Canada;United States | ||
| 12 | NCT00635141 (ClinicalTrials.gov) | March 2008 | 4/3/2008 | The Effect of Hypertonic Saline on the Lung Clearance Index in Patients With Cystic Fibrosis | The Effect of Inhaled Hypertonic Saline (7%) Versus Normal Saline (0.9%) on the Lung Clearance Index in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: hypertonic saline (7 %) and isotonic saline (0.9%) | The Hospital for Sick Children | Canadian Cystic Fibrosis Foundation | Completed | 6 Years | 18 Years | Both | 20 | Phase 3 | Canada |