This study was designed to examine the effectiveness of two bronchodilator inhalers in patients who have exercise-induced asthma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
albuterol HFA MDI 160 mcg
albuterol HFA BOI 160 mcg
placebo HFA
Colorado Allergy and Asthma Centers, PC
Denver, Colorado, United States
Colorado Allergy and Asthma Centers, PC
Englewood, Colorado, United States
Colorado Allergy and Asthma Centers, PC
Lakewood, Colorado, United States
The primary endpoint was mean maximum % change in the baseline absolute forced expiratory volume in 1 second (FEV1) value observed up to 1 hour post-challenge.
Time frame: Three doses 2-7 days apart
Mean maximum percent change in the baseline percent predicted FEV1 value observed up to one hour post-challenge
Time frame: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes
Mean maximum absolute change in the baseline absolute FEV1 value observed up to one hour post-challenge
Time frame: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes
Mean percent change in the baseline absolute FEV1 value at each post-challenge time point
Time frame: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes
Mean absolute change in the baseline absolute FEV1 value at each post-challenge time point
Time frame: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes
Mean percent change in the baseline percent-predicted FEV1 value at each post-challenge time point
Time frame: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes
Mean largest negative (or mean smallest positive) percent change in the baseline absolute FEV1 value observed up to one hour post-challenge
Time frame: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes
Mean largest negative (or mean smallest positive) percent change in the average test-day pre-dose baseline percent predicted FEV1 value observed up to one hour post-challenge
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Time frame: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes
Time to recovery (in minutes) measured from time of completion of exercise challenge to time FEV1 returns to 10% or less of baseline value during the recovery phase
Time frame: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes
Total changes in FEV1 expressed as the baseline-adjusted area-under-the-effect curve of the percent-predicted FEV1 versus time over 60 minutes (AUEC0 60)
Time frame: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes
Percentage of patients who are "protected" (maximum percent decrease in the baseline absolute FEV1 <10%), "partially protected" (10 20%), and "unprotected" (>20%).
Time frame: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes