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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
15
levalbuterol MDI 90 mcg QID
Placebo MDI QID
Unnamed facility
Denver, Colorado, United States
Unnamed facility
Burke, Virginia, United States
maximum percent FEV1 decrease from visit postdose/prechallenge
Time frame: Days 1, 4, 7
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
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