Clinical Trial: Efficacy Study of Single-Dose Levalbuterol Tartrate HFA MDI Vs Placebo in Subjects 18 Years and Older With EIB
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Efficacy Study of Single-Dose Levalbuterol Tartrate HFA MDI Versus Placebo in Prevention of EIB in Subjects 18 Years of Age and Older With EIB
Brief Summary: To determine if administration of levalbuterol tartrate HFA MDI in subjects with EIB will be effective in the prevention of EIB and be safe and well-tolerated.
Detailed Summary: This was a randomized, double-blind, placebo-controlled, multicenter, two-way crossover study of levalbuterol tartrate HFA MDI in subjects 18 years of age and older with EIB. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
Sponsor: Sunovion
Current Primary Outcome: maximum percent FEV1 decrease from visit postdose/prechallenge [ Time Frame: Days 1, 4, 7 ]
Original Primary Outcome:
Current Secondary Outcome:
- FEV1 area under the curve (AUC0-60 mins) (% decrease from visit postdose/prechallenge) [ Time Frame: Days 1, 4, 7 ]
- time to FEV1 recovery [ Time Frame: Days 1, 4, 7 ]
- minimum percent change in FEV1 from visit postdose/prechallenge [ Time Frame: Days 1, 4, 7 ]
- minimum percent change in FEV1 from visit predose [ Time Frame: Days 1, 4, 7 ]
- protected/unprotected subject counts (unprotected: >20% decrease; moderately protected: 10% to 20% decrease; and protected: <10% decrease from postdose/prechallenge FEV1) [ Time Frame: Days 1, 4, 7 ]
- percent change in FEV1 from predose to postdose/prechallenge [ Time Frame: Days 1, 4, 7 ]
Original Secondary Outcome:
Information By: Sunovion
Dates:
Date Received: December 20, 2005
Date Started: December 2005
Date Completion:
Last Updated: February 21, 2012
Last Verified: February 2012
