NCT06245551

A Study to Investigate the Effects of PT027 (Budesonide/Albuterol Sulfate) Metered-dose Inhaler Compared With Placebo on Exercise-Induced Bronchoconstriction in Adult Patients With Asthma

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Asthma, Exercise-Induced

Interventions

Type	Name	Description
DRUG	Budesonide/albuterol metered-dose inhaler 160/180 μg	Budesonide/albuterol combination aerosol for inhalation, single dose (given as 2 actuations of 80/90 μg)
DRUG	Placebo metered-dose inhaler	Placebo aerosol for inhalation, single dose (given as 2 actuations)

Timeline

• Start date: 2023-12-22
• Primary completion: 2024-06-29
• Completion: 2024-06-29
• First posted: 2024-02-07
• Last updated: 2025-08-27
• Results posted: 2025-08-27

Locations

6 sites across 1 country: Russia

Regulatory

• FDA-regulated drug study