A Study in Adult and Pediatric Patients With Cystic Fibrosis
Phase 1
Completed
- Conditions
- Cystic Fibrosis
- Registration Number
- NCT00034515
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this ascending dose group study is to assess the safety, tolerability, and effects of multiple dose levels of INS37217 and placebo followed by five days twice daily treatment with maximum tolerated dose administered by inhalation via the Pari LC Star nebulizer in adult and pediatric patients with cystic fibrosis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
Inclusion Criteria
- FEV1 40-70% (adults)
- FEV1 >/=50% (pediatrics)
- oxygen saturation >90%
- clinically stable
- willing to stay overnight
Exclusion Criteria
- abnormal renal or liver function
- receiving corticosteroids exceeding 10mg/day or 20 mg every other day
- received intravenous or aerosolized antibiotics 1 week prior to dosing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method assess safety and tolerability
- Secondary Outcome Measures
Name Time Method assess effects of INS37217 on sputum weight and symptoms