At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Single-dose, 2-Period, Crossover Study to Assess the Efficacy of PT027 Compared With Placebo on Exercise-Induced Bronchoconstriction in Adult and Adolescent Subjects With Asthma
In Brief
A Phase 3 clinical trial evaluating Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg and Placebo metered-dose inhaler for Exercise Induced Bronchospasm. Completed, enrolled 60 participants across 6 sites.
Detailed Summary
This is a multicenter, randomized, double-blind, single-dose, placebo-controlled, 2-period, crossover study to evaluate the efficacy and safety of budesonide/albuterol metered-dose inhaler (BDA MDI/PT027) as compared with a placebo metered-dose inhaler (placebo MDI) on exercise-induced bronchoconstriction (EIB) in adult and adolescent subjects with asthma. Subjects will receive each study treatment on separate visits and undergo a treadmill exercise challenge test for up to 10 minutes so that the effect of study treatment on exercise-induced bronchoconstriction can be evaluated.
Study Details
Timeline
Interventions
Budesonide/albuterol sulfate combination inhalation aerosol single dose
Placebo inhalation aerosol single dose