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

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to evaluate the safety and effectiveness of a one dose strength of denufosol compared to placebo in patients with mild CF lung disease.

• Phase: Phase 3
• 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 75% 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 suggesting clinically significant active pulmonary disease

• Be colonized with Burkholderia cepacia

• Have had a lung transplant