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

Merck Sharp & Dohme LLC90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cystic Fibrosis

Interventions

denufosol tetrasodium (INS37217)DRUG

Eligibility

Sex: ALLMin age: 8 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

lung function

respiratory symptoms

sputum weight

pulmonary exacerbations

measures of lung characteristics

Secondary Outcomes

safety measures

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.