Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease
Phase 2
Completed
- Conditions
- Cystic Fibrosis
- Registration Number
- NCT00103714
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of two dose levels of INS37217 (denufosol tetrasodium) Inhalation Solution in patients with cystic fibrosis (CF) lung disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
- Have confirmed diagnosis of CF
- Have an FEV1 greater than or equal to 60% or less than or equal to 90% of predicted normal
- Have oxygen saturation greater than or equal to 90% on room air
- Be clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation
- Be able to reproducibly perform spirometry maneuvers
Exclusion Criteria
- Have changed their physiotherapy technique or schedule within 7 days prior to screening
- Have clinically significant comorbidities
- Using prior and concurrent medications according to the 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 respiratory symptoms via questionnaire pulmonary exacerbation