Status:
TERMINATED
Study of Denufosol Inhalation Solution in Patients With Mild to Moderate Cystic Fibrosis Lung Disease
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
10+ years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00425165
Start Date
August 1 2007
End Date
May 1 2008
Last Update
April 3 2015
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