The purpose of this Phase III, multicentre, randomized, double-blind, single-dose, 2-period, crossover study is to assess the efficacy and safety of PT027 (budesonide/albuterol sulfate) metered-dose inhaler compared with placebo on exercise-induced bronchoconstriction in adult patients with asthma. Subjects will receive each study treatment on separate visits and undergo a treadmill exercise challenge test so that the effect of study treatment on exercise-induced bronchoconstriction can be evaluated
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
Budesonide/albuterol combination aerosol for inhalation, single dose (given as 2 actuations of 80/90 μg)
Placebo aerosol for inhalation, single dose (given as 2 actuations)
Research Site
Moscow, Russia
Research Site
Penza, Russia
Research Site
Perm, Russia
Research Site
Saint Petersburg, Russia
Research Site
Saratov, Russia
Research Site
Ulyanovsk, Russia
Maximum Percentage Fall From Post-dose, Pre-exercise Baseline in Forced Expiratory Volume in 1 Second (FEV₁) Observed up to 60 Minutes Post-exercise Challenge
Lung function was measured by spirometry. Spirometry assessments were completed 5 minutes before dosing, 30 minutes after dosing (baseline; 5 minutes before the exercise challenge), and then 5, 10, 15, 30, and 60 minutes after the exercise challenge. A reduction in FEV₁ was expected due to the effects of asthma and exercise on breathing and lung function. The percentage fall in FEV₁ was calculated based on the baseline value and maximum percentage fall value during the 60-minute assessment period.
Time frame: Up to 60 minutes post-exercise challenge
Percentage of Subjects With a Maximum Percentage Fall in FEV₁ Post-exercise Challenge of <10% and <20%
The percentage fall in FEV₁ was calculated based on the baseline value and maximum percentage fall value during the 60-minute assessment period, and the percentage of subjects with a maximum percentage fall \<10% and \<20% was determined
Time frame: Up to 60 minutes post exercise challenge
Percentage Fall From Post-dose, Pre-exercise Baseline in FEV1 at Each Time Point Within 60 Minutes Post-exercise Challenge
The percentage fall in FEV₁ at each time point was calculated based on the baseline value and percentage fall value during the 60-minute assessment period at each time point.
Time frame: Up to 60 minutes post exercise challenge
Post-Exercise FEV1 Area Under the Curve From 0 to 30 Minutes (AUC0-30min)
FEV1 AUC0-30min will be derived for the changes from the post-dose, pre-exercise baseline using the trapezoidal rule and will be normalized by dividing by the actual time (in minutes) from dosing to the last included measurement, scheduled at 30 minutes post-exercise challenge.
Time frame: Up to 30 minutes post exercise challenge
Time To Recovery
Time to recovery will be derived as the time (minutes) post-exercise challenge in which the FEV1 result returns to within 10% of the value recorded at the post-dose, pre-exercise baseline.
Time frame: Up to 60 minutes post exercise challenge
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