299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details
臨床試験数 : 1,695 / 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
| 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 | EUCTR2015-004143-39-IT (EUCTR) | 19/12/2018 | 20/09/2018 | Saline hypertonic in preschoolers and lung structure as measured by computed tomography. | A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;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: Hypertonic saline INN or Proposed INN: SODIUM CHLORIDE 7% Other descriptive name: SODIUM CHLORIDE 7% Product Name: Isotonic saline INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9% Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9% | Erasmus MC | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | France;United States;Spain;Belgium;Denmark;Australia;Netherlands;Italy | ||
| 2 | EUCTR2015-004143-39-ES (EUCTR) | 19/04/2017 | 31/03/2017 | Saline hypertonic in preschoolers and lung structure as measured by computed tomography. | A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study | Cystic Fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 19.1;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: Hypertonic saline INN or Proposed INN: HYPERTONIC SALINE Other descriptive name: SALINE Product Name: Isotonic saline INN or Proposed INN: ISOTONIC SALINE Other descriptive name: STERILE PYROGEN-FREE ISOTONIC NACL SOLUTE (0.9% W / V) | Erasmus MC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Spain;Denmark;Australia;Netherlands | ||
| 3 | EUCTR2015-004143-39-DK (EUCTR) | 14/02/2017 | 25/10/2016 | Saline Hypertonic in Preschoolers with cystic fibrosis and lung structure asmeasured by computedtomography (CT). SHIP-CT study. | A Phase 3 randomised, double-blind, controlled trial of inhaled 7%hypertonic saline versus0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6years of age inparallel with the North American SHIP clinical trial - Ship-CT study | Cystic fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Hypertonic saline INN or Proposed INN: sodium chloride 7% Other descriptive name: SODIUM CHLORIDE 7% Product Name: Isotonic saline 0.9% INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9% Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9% | Erasmus MC | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | France;United States;Spain;Belgium;Australia;Denmark;Netherlands;Italy | ||
| 4 | NCT02947126 (ClinicalTrials.gov) | January 2017 | 25/10/2016 | Multilevel Models of Therapeutic Response in the Lungs | Multilevel Models of Therapeutic Response in the Lungs | Cystic Fibrosis | Drug: Hypertonic Saline;Drug: Isotonic Saline;Drug: Indium-DTPA;Drug: Technetium Sulfur Colloid | Tim Corcoran | National Heart, Lung, and Blood Institute (NHLBI) | Completed | 12 Years | N/A | All | 56 | Phase 1 | United States |
| 5 | EUCTR2015-004143-39-BE (EUCTR) | 30/11/2016 | 13/10/2016 | Saline hypertonic in preschoolers and lung structure as measured by computed tomography. | A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study | Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 19.0;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: Hypertonic saline INN or Proposed INN: SODIUM CHLORIDE 7% Other descriptive name: SODIUM CHLORIDE 7% Product Name: Isotonic saline INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9% Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9% | Erasmus MC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Spain;Belgium;Denmark;Australia;Netherlands | ||
| 6 | EUCTR2015-004143-39-NL (EUCTR) | 09/08/2016 | 21/12/2015 | Saline hypertonic in preschoolers and lung structure as measured by computed tomography. | A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;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: Hypertonic saline INN or Proposed INN: SODIUM CHLORIDE 7% Other descriptive name: SODIUM CHLORIDE 7% Product Name: Isotonic saline INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9% Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9% | Erasmus MC | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | France;United States;Spain;Belgium;Denmark;Australia;Netherlands;Italy | ||
| 7 | NCT02950883 (ClinicalTrials.gov) | March 24, 2015 | 27/10/2016 | Saline Hypertonic in Preschoolers + CT | Saline Hypertonic in Preschoolers With Cystic Fibrosis and Lung Structure as Measured by Computed Tomography (CT) | Cystic Fibrosis | Drug: Active Treatment Group 7% Hypertonic Saline;Drug: Control Group 0.9% Isotonic Saline | University of Washington, the Collaborative Health Studies Coordinating Center | Cystic Fibrosis Foundation | Completed | 3 Years | 5 Years | All | 116 | Phase 2/Phase 3 | United States;Australia;Belgium;Canada;Denmark;France;Italy;Netherlands;Spain |
| 8 | NCT02378467 (ClinicalTrials.gov) | March 1, 2015 | 27/2/2015 | Saline Hypertonic in Preschoolers | Saline Hypertonic in Preschoolers | Cystic Fibrosis | Drug: 7% Hypertonic Saline (HS);Drug: 0.9% Isotonic Saline (IS) | University of Washington, the Collaborative Health Studies Coordinating Center | Cystic Fibrosis Foundation | Completed | 3 Years | 5 Years | All | 150 | N/A | United States;Canada |
| 9 | NCT01619657 (ClinicalTrials.gov) | June 2012 | 12/6/2012 | Preventive Inhalation of Hypertonic Saline in Infants With Cystic Fibrosis | Randomized, Double-blind, Controlled Pilot Study on Safety of Hypertonic Saline as Preventive Inhalation Therapy in Newborns and Infants With Cystic Fibrosis | Cystic Fibrosis Lung Disease | Drug: 6% Hypertonic Saline (HS), 4mL;Drug: 0.9% Isotonic Saline (IS), 4mL | Heidelberg University | German Center for Lung Research | Completed | N/A | 4 Months | All | 42 | Phase 2 | Germany |
| 10 | 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 |
| 11 | NCT01223183 (ClinicalTrials.gov) | September 2010 | 14/10/2010 | Absorptive Clearance After Inhaled Osmotics in Cystic Fibrosis | Absorptive Clearance After Inhaled Osmotics in Cystic Fibrosis | Cystic Fibrosis | Drug: hypertonic saline (7%);Drug: isotonic saline | University of Pittsburgh | NULL | Completed | 18 Years | N/A | All | 20 | Phase 1 | United States |
| 12 | NCT00709280 (ClinicalTrials.gov) | April 2009 | 1/7/2008 | Infant Study of Inhaled Saline in Cystic Fibrosis | Infant Study of Inhaled Saline in Cystic Fibrosis | Cystic Fibrosis | Drug: 7% Hypertonic Saline (HS);Drug: 0.9% Isotonic Saline (IS) | CF Therapeutics Development Network Coordinating Center | Cystic Fibrosis Foundation Therapeutics;National Heart, Lung, and Blood Institute (NHLBI) | Completed | 4 Months | 59 Months | Both | 321 | N/A | United States;Canada |
| 13 | 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 |
| 14 | NCT00628134 (ClinicalTrials.gov) | March 2008 | 22/2/2008 | Self-dispersing Liquids as Aerosol Drug Carriers | Self-dispersing Liquids as Aerosol Drug Carriers | Cystic Fibrosis | Drug: calfactant;Drug: isotonic saline | University of Pittsburgh | Cystic Fibrosis Foundation Therapeutics | Completed | 18 Years | N/A | All | 8 | N/A | United States |
| 15 | NCT00534079 (ClinicalTrials.gov) | September 2007 | 21/9/2007 | Nasal Inhalation of Pulmozyme in Patients With Cystic Fibrosis and Chronic Rhinosinusitis | Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis - a Double Blind Placebo-controlled Cross-over, Bicenter, Prospective Clinical Study | Cystic Fibrosis;Rhinosinusitis | Drug: Dornase alfa (Pulmozyme);Drug: isotonic saline | University of Jena | NULL | Completed | 5 Years | N/A | Both | 23 | Phase 3 | Germany |
| 16 | EUCTR2015-004143-39-FR (EUCTR) | 30/03/2017 | Saline hypertonic in preschoolers and lung structure as measured by computed tomography. | A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;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: Hypertonic saline 7% INN or Proposed INN: SODIUM CHLORIDE Other descriptive name: SODIUM CHLORIDE PH. EUR. Product Name: Isotonic saline 0.9% INN or Proposed INN: SODIUM CHLORIDE Other descriptive name: SODIUM CHLORIDE PH. EUR. | Erasmus MC | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | United States;France;Spain;Belgium;Denmark;Australia;Netherlands;Italy |