Cystic Fibrosis Clinical Trial
Official title:
Multi-Center, Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of INS37217 Inhalation Solution in Subjects With Mild to Moderate Cystic Fibrosis Lung Disease
Verified date | January 2015 |
Source | Merck Sharp & Dohme Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 90 |
Est. completion date | February 2004 |
Est. primary completion date | February 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 8 Years to 50 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. | Cystic Fibrosis Foundation Therapeutics |
Deterding RR, Lavange LM, Engels JM, Mathews DW, Coquillette SJ, Brody AS, Millard SP, Ramsey BW; Cystic Fibrosis Therapeutics Development Network and the Inspire 08-103 Working Group. Phase 2 randomized safety and efficacy trial of nebulized denufosol te — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | lung function | |||
Primary | respiratory symptoms | |||
Primary | sputum weight | |||
Primary | pulmonary exacerbations | |||
Primary | measures of lung characteristics | |||
Secondary | safety measures |
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