Study of Denufosol Inhalation Solution in Patients With Mild to Moderate Cystic Fibrosis Lung Disease

Phase 2

Terminated

• Conditions: Cystic Fibrosis

• Registration Number: NCT00425165
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this trial is to evaluate the effects of a single dose of denufosol versus placebo on mucociliary clearance in patients with mild to moderate CF lung disease

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2007-01-19
• Study First Submitted QC: 2007-01-19
• Study First Posted: 2007-01-22
• Study Start: 2007-08
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Disposition First Submitted: 2011-03-31
• Disposition First Submitted QC: 2011-03-31
• Disposition First Posted: 2011-04-07
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-04-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• have confirmed diagnosis of cystic fibrosis
• have FEV1 of greater than or equal to 60% of predicted normal for age, gender, and height
• be able to reproducibly perform spirometry maneuvers
• be clinically stable for at least 4 weeks prior to screening

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Exclusion Criteria

• have abnormal renal or liver function
• have chest x-ray at screening with abnormalities suggesting clinically significant active pulmonary disease
• have had a lung transplant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in mucociliary clearance from baseline	30, 60, and 90 minutes post aerosol inhalation