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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Cystic Fibrosis

Treatments: Drug: denufosol tetrasodium (INS37217) Inhalation Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00425165

08-111

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind