Cystic Fibrosis Clinical Trial
Official title:
Multi-Center, Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of INS37217 Inhalation Solution in Subjects With Mild to Moderate Cystic Fibrosis Lung Disease
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).
The purpose of this study is to:
- assess the safety and efficacy of multiple dose levels of INS37217 compared to placebo
over 28 days in subjects with mild to moderate CF lung disease;
- explore evidence of activity of INS37217 and placebo administered via PARI LC STAR
nebulizer;
- identify dose(s) that will be studied in subsequent trials.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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