Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis Lung Disease
NCT00056147 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2015-01-29
Summary
The purpose of this study is to assess the safety and effectiveness of multiple dosages of INS37217 compared to placebo over 28 days in subjects with mild to moderate cystic fibrosis (CF) lung disease. Study drug will be administered through a nebulizer (a device that delivers medication as a mist by breathing it in).
Conditions
Interventions
- DRUG
-
denufosol tetrasodium (INS37217)
Sponsors & Collaborators
-
Cystic Fibrosis Foundation
collaborator OTHER - 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
- 2003-04-30
- Primary Completion
- 2004-02-29
- Completion
- 2004-02-29
More Related Trials
-
Study of Denufosol Inhalation Solution in Patients With Mild to Moderate Cystic Fibrosis Lung Disease
NCT00425165 ·Status: TERMINATED ·Phase: PHASE2
-
Safety Study of Inhaled 552-02 in Cystic Fibrosis Patients
NCT00274313 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study to Evaluate the Safety & Tolerability of MRT5005 Administered by Nebulization in Adults With Cystic Fibrosis
NCT03375047 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Safety and Tolerability Study of Denufosol in 2-4 Year Olds
NCT01181622 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Pharmacokinetics and Pharmacodynamics Study of Inhaled QBW276 in Patients With Cystic Fibrosis
NCT02566044 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
The Effects of Long Term Inhalation of Hypertonic Saline in Subjects With Cystic Fibrosis
NCT00271310 ·Status: COMPLETED ·Phase: PHASE3
-
Infant Study of Inhaled Saline in Cystic Fibrosis
NCT00709280 ·Status: COMPLETED ·Phase: NA
-
Safety and Efficacy of Inhaled OligoG CF-5/20 for the Treatment Cystic Fibrosis
NCT00970346 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QAU145 in Patients With Cystic Fibrosis
NCT00506792 ·Status: COMPLETED ·Phase: PHASE2
-
A Study Assessing KB407 for the Treatment of Cystic Fibrosis
NCT05504837 ·Status: RECRUITING ·Phase: PHASE1
-
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis
NCT05090904 ·Status: COMPLETED ·Phase: PHASE2
-
A Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
NCT03056989 ·Status: COMPLETED ·Phase: PHASE1
-
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
-
Utility of Induced Sputum Using Hypertonic Saline to Evaluate Infection and Inflammation in Cystic Fibrosis
NCT00721071 ·Status: COMPLETED ·Phase: PHASE2
-
Self-dispersing Liquids as Aerosol Drug Carriers
NCT00628134 ·Status: COMPLETED ·Phase: NA
-
Safety, Pharmacokinetic and Pharmacodynamic Study of MP-376 in Patients With Cystic Fibrosis
NCT00503490 ·Status: COMPLETED ·Phase: PHASE1
-
Inhaled Mannitol on Mucociliary Clearance in Moderate to Severe Cystic Fibrosis
NCT05740618 ·Status: COMPLETED ·Phase: PHASE4
-
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
-
Safety, Tolerability and Efficacy of MP-376 Given for 28 Days to Cystic Fibrosis (CF) Patients
NCT00677365 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase I Study of Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis.
NCT00332215 ·Status: TERMINATED ·Phase: PHASE1
-
Safety Study of Fenretinide in Adult Patients With Cystic Fibrosis
NCT02141958 ·Status: COMPLETED ·Phase: PHASE1
-
The Effect of Hypertonic Saline on the Lung Clearance Index in Patients With Cystic Fibrosis
NCT00635141 ·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
-
A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis
NCT03911713 ·Status: COMPLETED ·Phase: PHASE2
-
An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
NCT03229252 ·Status: COMPLETED ·Phase: PHASE2