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

NCT ID: NCT00425165

Last Updated: 2015-04-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2008-05-31

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

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Interventions

denufosol tetrasodium (INS37217) Inhalation Solution

Denufosol 60 mg is administered as an inhalation solution one time during the study.

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

08-111

Identifier Type: -

Identifier Source: org_study_id