Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis Lung Disease

• Status: Completed
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety and effectiveness of multiple dosages of INS37217 compared to placebo over 28 days in subjects with mild to moderate cystic fibrosis (CF) lung disease. Study drug will be administered through a nebulizer (a device that delivers medication as a mist by breathing it in).

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

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Collaborators: Cystic Fibrosis Foundation; Cystic Fibrosis Foundation Therapeutics

Criteria

Inclusion Criteria:

• confirmed diagnosis of CF

• FEV1 greater than or equal to 75% of predicted normal for age, gender, and height

• oxyhemoglobin saturation greater than or equal to 90%

• clinically stable

Exclusion Criteria:

• abnormal renal or liver function

• clinically significant findings atypical for moderate cystic fibrosis