The purpose of this study is to compare the safety and tolerability of levalbuterol HFA metered dose inhaler (MDI) versus racemic albuterol HFA MDI.
A randomized, modified-blind active-controlled multicenter, two-way crossover study of HFA levalbuterol (without using a spacer) in subjects 12 years of age and older with asthma. 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
DOUBLE
Enrollment
49
1. Subjects will receive both treatments: (a) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses); followed by (b) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses) 2. Arm #A 3. Xopenex HFA MDI, albuterol HFA MDI
1. Subjects will receive both treatments: (a) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses) followed by (b) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses) 2. Arm #B 3. albuterol HFA MDI, Xopenex HFA MDI
Unnamed facility
Encinitas, California, United States
Unnamed facility
North Dartmouth, Massachusetts, United States
Unnamed facility
St Louis, Missouri, United States
Increases from visit pre-dose to each post-dose dose measurement in heart rate, blood pressure (systolic and diastolic).
Time frame: Days 0, 7, 10
Increases from visit pre-dose to each post-dose dose measurement in potassium and glucose
Time frame: Days 0, 7
FEV1 (percent change from visit pre-dose to each post dose measure)
Time frame: Days 0, 7, 10
FVC (percent change from visit pre-dose to each post dose measure);
Time frame: Days 0, 7, 10
FEF25-75% (percent change from visit pre-dose to each post dose measure);
Time frame: Days 0, 7, 10
Number of cumulative actuations received
Time frame: Days 0, 7, 10
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