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

Phase 2

Completed

• Conditions: Cystic Fibrosis

• Registration Number: NCT00056147
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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).

Detailed Description

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.

Study Timeline

• Study First Submitted: 2003-03-06
• Study First Submitted QC: 2003-03-06
• Study First Posted: 2003-03-07
• Study Start: 2003-04
• Primary Completion: 2004-02
• Study Completion: 2004-02
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-28
• Last Update Posted: 2015-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
respiratory symptoms
sputum weight
measures of lung characteristics
pulmonary exacerbations
lung function

Secondary Outcome Measures

Name	Time	Method
safety measures