Study of Denufosol Inhalation Solution in Patients With Mild to Moderate Cystic Fibrosis Lung Disease
Phase 2
Terminated
- Conditions
- Cystic Fibrosis
- Registration Number
- NCT00425165
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Change in mucociliary clearance from baseline 30, 60, and 90 minutes post aerosol inhalation
- Secondary Outcome Measures
Name Time Method