A Study in Pediatric Patients With Cystic Fibrosis Lung Disease
Phase 2
Completed
- Conditions
- Cystic Fibrosis
- Registration Number
- NCT00130182
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to investigate the safety and effectiveness of two dose strengths of study drug compared to placebo in pediatric patients with cystic fibrosis (CF).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
Inclusion Criteria
- Have confirmed diagnosis of CF
- Have an FEV1 greater than or equal to 60%
- Have oxygen saturation greater than or equal to 90% on room air
- Be clinically stable for at least 4 weeks prior to screening
- Be able to reproducibly perform spirometry maneuvers
Exclusion Criteria
- Have clinically significant comorbidities
- Have changed their physiotherapy technique or schedule within 7 days prior to screening
- Using prior and concurrent medications according to protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method respiratory function
- Secondary Outcome Measures
Name Time Method adverse events change in standard safety parameters pulmonary exacerbation
Trial Locations
- Locations (3)
General Clinic Research Center University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
The Minnesota CF Center
🇺🇸Minneapolis, Minnesota, United States
The Children's Hospital
🇺🇸Denver, Colorado, United States