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 | 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 |
| 2 | NCT01658449 (ClinicalTrials.gov) | December 2009 | 13/7/2012 | Comparison of the Tolerability of Two Formulations of Hypertonic Saline in Cystic Fibrosis Patients | Cystic Fibrosis | Other: Inhalable Hypertonic saline 7% + Hyaluronan 0.1%;Other: Inhalable Hypertonic saline 7% | Ospedale Civile Ca' Foncello | NULL | Completed | 8 Years | N/A | Both | 40 | N/A | Italy | |
| 3 | 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 |