Study of Denufosol Inhalation Solution in Patients With Mild to Moderate Cystic Fibrosis Lung Disease

• Status: Terminated
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Pharmaceutical Solutions

Criteria

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