Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) Lung Disease

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to evaluate the safety and effectiveness of one dose strength of Denufosol compared to placebo in patients with CF and a predicted FEV1 of greater than or equal to 75% but less than or equal to 110% predicted.

• 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% but less than or equal to 110%predicted normal for age, gender and height

• Be able to reproducibly perform spirometry

• Be clinically stable for at least 4 weeks before screening

Exclusion Criteria:

• Have abnormal renal or liver function

• Have lung transplant

• Unable to discontinue use of hypertonic saline

• Participated in Inspire trial 08-108