Status:
COMPLETED
Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
8-50 years
Phase:
PHASE2
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 fibros...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00103714
Start Date
January 1 2005
End Date
August 1 2005
Last Update
October 20 2015
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