Cystic Fibrosis
Conditions
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
Interventions
Denufosol 60 mg is administered as an inhalation solution one time during the study.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mucociliary clearance from baseline | 30, 60, and 90 minutes post aerosol inhalation |
Outcome results
None listed