A Safety and Tolerability Study of Denufosol in 2-4 Year Olds
Phase 2
Completed
- Conditions
- Cystic Fibrosis
- Interventions
- Drug: 0.9% w/v sodium chloride solution
- Registration Number
- NCT01181622
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to evaluate the safety and tolerability of denufosol 60 mg TID in pediatric CF patients 2 to 4 years of age
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
- Have a confirmed diagnosis of CF
- Have oxyhemoglobin saturation ≥ 95% prior to randomization
Exclusion Criteria
- Have acute intercurrent respiratory infection (cough, wheezing, or new
rhinorrhea or nasal congestion)
- Have any significant medical condition not related to CF
- Unable to discontinue use of hypertonic saline
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description denufosol tetrasodium Inhalation Solution denufosol tetrasodium Inhalation Solution - Placebo 0.9% w/v sodium chloride solution -
- Primary Outcome Measures
Name Time Method Intolerability to study drug as measured by: oxyhemoglobin saturation, treatment-emergent cough, and new wheezes or crackles Day 1, Day 7
- Secondary Outcome Measures
Name Time Method Mean change from baseline in pulse and respiratory rate Day 7 Incidence of new medical condition(s) or worsening of previous medical condition(s) from baseline Day 7 Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and/or withdrawals due to TEAEs Day 7 Mean change from pre-dose in pulse and respiratory rate at defined times post-dose Day 1, Day 7 Mean change from pre-dose in oxyhemoglobin saturation at defined times post-dose Day 1, Day 7 Mean change from baseline in oxyhemoglobin saturation Day 7