NCT00425165TerminatedPhase 2
A Randomized, Double-Blind, Two Way Crossover Evaluation of the Effects of a Single Dose of Denufosol Tetrasodium (INS37217) Inhalation Solution Versus Placebo (0.9% Sodium Chloride Solution) on Mucociliary Clearance in Patients With Mild to Moderate Cystic Fibrosis Lung Disease
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 6
- Primary Endpoint
- Change in mucociliary clearance from baseline
Study Overview
Brief Summary
The purpose of this trial is to evaluate the effects of a single dose of denufosol versus placebo on mucociliary clearance in patients with mild to moderate CF lung disease
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 10 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •have confirmed diagnosis of cystic fibrosis
- •have FEV1 of greater than or equal to 60% of predicted normal for age, gender, and height
- •be able to reproducibly perform spirometry maneuvers
- •be clinically stable for at least 4 weeks prior to screening
Exclusion Criteria
- •have abnormal renal or liver function
- •have chest x-ray at screening with abnormalities suggesting clinically significant active pulmonary disease
- •have had a lung transplant
Outcomes
Primary Outcomes
Change in mucociliary clearance from baseline
Time Frame: 30, 60, and 90 minutes post aerosol inhalation
Secondary Outcomes
No secondary outcomes reported
Investigators
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