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 - BREATH

Study identifier:AZ-RU-00004

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

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)

Medical condition

Asthma, Exercise-Induced

Phase

Phase 3

Healthy volunteers

No

Study drug

Budesonide/albuterol metered-dose inhaler 160/180 μg, Placebo metered-dose inhaler

Sex

All

Estimated Enrollment

64

Study type

Interventional

Age

18 Years - 70 Years

Date

Study Start Date: 22 Dec 2023
Estimated Primary Completion Date: 23 Jul 2024
Estimated Study Completion Date: 23 Jul 2024

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria