At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Multicentre, Randomized, Double-blind, Single-Dose, 2-Arm, 2-Period, Crossover Study to Investigate the Efficacy of PT027 Compared With Placebo on Exercise-Induced Bronchoconstriction in Adult Patients With Asthma (BREATH)
In Brief
A Phase 3 clinical trial evaluating Budesonide/albuterol metered-dose inhaler 160/180 μg and Placebo metered-dose inhaler for Asthma, Exercise-Induced. Completed, enrolled 64 participants across 6 sites.
Detailed Summary
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 Details
Timeline
Interventions
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)