Status:
COMPLETED
Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) 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 one dose strength of Denufosol compared to placebo in patients with CF and a predicted FEV1 of greater than or equal to 75% but...
Eligibility Criteria
Inclusion
- Have confirmed diagnosis of cystic fibrosis
- Have FEV1 of greater than or equal to 75% but less than or equal to 110%predicted normal for age, gender and height
- Be able to reproducibly perform spirometry
- Be clinically stable for at least 4 weeks before screening
Exclusion
- Have abnormal renal or liver function
- Have lung transplant
- Unable to discontinue use of hypertonic saline
- Participated in Inspire trial 08-108
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
466 Patients enrolled
Trial Details
Trial ID
NCT00625612
Start Date
February 1 2008
End Date
October 1 2010
Last Update
November 2 2015
Active Locations (106)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Pediatric Breathing Disorders
Anchorage, Alaska, United States, 99508
3
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
4
University of Arizona/Arizona Health Sciences
Tucson, Arizona, United States, 85724