Efficacy Study of Single-Dose Levalbuterol Tartrate HFA MDI Vs Placebo in Subjects 18 Years and Older With EIB
Phase 3
Completed
- Conditions
- Exercise-induced Bronchospasm
- Interventions
- Drug: Placebo
- Registration Number
- NCT00268723
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- 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 Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Levalbuterol tartrate HFA MDI levalbuterol HFA MDI 90 mcg QID 2 Placebo Placebo MDI QID
- Primary Outcome Measures
Name Time Method maximum percent FEV1 decrease from visit postdose/prechallenge Days 1, 4, 7
- Secondary Outcome Measures
Name Time Method FEV1 area under the curve (AUC0-60 mins) (% decrease from visit postdose/prechallenge) Days 1, 4, 7 time to FEV1 recovery Days 1, 4, 7 minimum percent change in FEV1 from visit postdose/prechallenge Days 1, 4, 7 minimum percent change in FEV1 from visit predose 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) Days 1, 4, 7 percent change in FEV1 from predose to postdose/prechallenge Days 1, 4, 7