Cystic Fibrosis
Conditions
Keywords
cystic fibrosis
Brief summary
The purpose of this study is to assess the safety and effectiveness of multiple dosages of INS37217 compared to placebo over 28 days in subjects with mild to moderate cystic fibrosis (CF) lung disease. Study drug will be administered through a nebulizer (a device that delivers medication as a mist by breathing it in).
Detailed description
The purpose of this study is to: * assess the safety and efficacy of multiple dose levels of INS37217 compared to placebo over 28 days in subjects with mild to moderate CF lung disease; * explore evidence of activity of INS37217 and placebo administered via PARI LC STAR nebulizer; * identify dose(s) that will be studied in subsequent trials.
Interventions
Sponsors
Cystic Fibrosis Foundation
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* confirmed diagnosis of CF * FEV1 greater than or equal to 75% of predicted normal for age, gender, and height * oxyhemoglobin saturation greater than or equal to 90% * clinically stable
Exclusion criteria
* abnormal renal or liver function * clinically significant findings atypical for moderate cystic fibrosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| lung function | — |
| respiratory symptoms | — |
| sputum weight | — |
| pulmonary exacerbations | — |
| measures of lung characteristics | — |
Secondary
| Measure | Time frame |
|---|---|
| safety measures | — |
Outcome results
None listed