Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease
NCT00103714 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2015-10-20
Summary
The objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of two dose levels of INS37217 (denufosol tetrasodium) Inhalation Solution in patients with cystic fibrosis (CF) lung disease.
Conditions
Interventions
- DRUG
-
denufosol tetrasodium (INS37217)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Amy Schaberg, BSN
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 8 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-01-31
- Primary Completion
- 2005-08-31
- Completion
- 2005-08-31
More Related Trials
-
A Safety and Tolerability Study of Denufosol in 2-4 Year Olds
NCT01181622 ·Status: COMPLETED ·Phase: PHASE2
-
A Study in Adult and Pediatric Patients With Cystic Fibrosis
NCT00034515 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study 08-114 Open-label Extension of Study 08-110 - A Multi-Center Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis Lung Disease (P08642)
NCT00846781 ·Status: TERMINATED ·Phase: PHASE3
-
Study to Evaluate the Safety & Tolerability of MRT5005 Administered by Nebulization in Adults With Cystic Fibrosis
NCT03375047 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety Study of Inhaled 552-02 in Cystic Fibrosis Patients
NCT00274313 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety, Pharmacokinetics and Pharmacodynamics Study of Inhaled QBW276 in Patients With Cystic Fibrosis
NCT02566044 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis
NCT03451045 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis
NCT05090904 ·Status: COMPLETED ·Phase: PHASE2
-
Clearing Lungs With Epithelial Sodium Channel (ENaC) Inhibition in Cystic Fibrosis (CF)
NCT02343445 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPL84 in Patients With Cystic Fibrosis
NCT06429176 ·Status: RECRUITING ·Phase: PHASE2
-
Safety and Tolerability Trial of Inhaled Alpha1-Proteinase Inhibitor (Human), Hydrophobic Chromatography Process (Alpha-1 HC) in Subjects With Cystic Fibrosis
NCT01684410 ·Status: COMPLETED ·Phase: PHASE2
-
An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
NCT03229252 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QAU145 in Patients With Cystic Fibrosis
NCT00506792 ·Status: COMPLETED ·Phase: PHASE2
-
Infant Study of Inhaled Saline in Cystic Fibrosis
NCT00709280 ·Status: COMPLETED ·Phase: NA
-
Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis.
NCT00308243 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Pharmacokinetic Study of N6022 in Subjects With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation
NCT01746784 ·Status: COMPLETED ·Phase: PHASE1
-
Self-dispersing Liquids as Aerosol Drug Carriers
NCT00628134 ·Status: COMPLETED ·Phase: NA
-
The Effects of Long Term Inhalation of Hypertonic Saline in Subjects With Cystic Fibrosis
NCT00271310 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eRapid Nebulizer System in Patients With Cystic Fibrosis
NCT01712334 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Efficacy of Inhaled OligoG CF-5/20 for the Treatment Cystic Fibrosis
NCT00970346 ·Status: COMPLETED ·Phase: PHASE1
-
Phase 1b Safety, Tolerability, and PK Study to Assess GS-5737 in Subjects With CF
NCT01840735 ·Status: COMPLETED ·Phase: PHASE1
-
Safety Study of Fenretinide in Adult Patients With Cystic Fibrosis
NCT02141958 ·Status: COMPLETED ·Phase: PHASE1
-
A Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
NCT03056989 ·Status: COMPLETED ·Phase: PHASE1
-
Utility of Induced Sputum Using Hypertonic Saline to Evaluate Infection and Inflammation in Cystic Fibrosis
NCT00721071 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability and Efficacy of MP-376 Given for 28 Days to Cystic Fibrosis (CF) Patients
NCT00677365 ·Status: COMPLETED ·Phase: PHASE2