Status:
COMPLETED
Study of Denufosol Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
5+ years
Phase:
PHASE3
Brief Summary
The purpose of this trial is to evaluate the safety and effectiveness of a one dose strength of denufosol compared to placebo in patients with mild CF lung disease.
Eligibility Criteria
Inclusion
- Have confirmed diagnosis of cystic fibrosis
- Have FEV1 of greater than or equal to 75% 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 suggesting clinically significant active pulmonary disease
- Be colonized with Burkholderia cepacia
- Have had a lung transplant
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
352 Patients enrolled
Trial Details
Trial ID
NCT00357279
Start Date
July 1 2006
End Date
September 1 2008
Last Update
November 4 2015
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