A study to investigate the effect on lung function of BDA formulated with a new propellant (HFO) compared with an approved asthma treatment (BDA with HFA propellant) in participants with asthma

Study identifier:D6933C00002

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Will Be Recruiting

Official Title

A Randomized, Placebo-controlled, Double-blind, Multicenter, 12-Week, 3-Way, Partial-replicate Crossover Pharmacodynamic Study to Assess the Equivalence of Budesonide and Albuterol (BDA) Delivered by MDI HFO Compared with BDA Delivered by MDI HFA in Participants with Asthma

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

No

Study drug

BDA MDI HFO 160/180 μg, BDA MDI HFA 160/180 μg, Placebo MDI HFA

Sex

All

Estimated Enrollment

398

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 29 Jul 2024
Estimated Primary Completion Date: 03 Mar 2026
Estimated Study Completion Date: 03 Mar 2026

Study design

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

Verification:

Verified 01 Jul 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria