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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Cystic Fibrosis

Treatments: Drug: denufosol tetrasodium (INS37217)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00056147

08-103

Details and patient eligibility

About

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).

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 8 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind