A study to investigate the effect on lung function of an approved COPD treatment (BGF, with HFA propellant) compared to BGF formulated with a new propellant (HFO) in participants 40 to 80 years of age with COPD

Study identifier:D5985C00002

ClinicalTrials.gov identifier:NCT06075095

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

A Randomised, Placebo-Controlled, Double-Blind, Multi-Centre, 4-week, 3-way Crossover Pharmacodynamic Study to Assess the Equivalence of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO Compared with BGF Delivered by MDI HFA in Participants with Chronic Obstructive Pulmonary Disease

Medical condition

COPD (Chronic Obstructive Pulmonary Disease)

Phase

Phase 3

Healthy volunteers

No

Study drug

BGF MDI HFO 320/14.4/9.6μg, BGF MDI HFA 320/14.4/9.6 μg, Placebo MDI HFA

Sex

All

Estimated Enrollment

255

Study type

Interventional

Age

40 Years - 80 Years

Date

Study Start Date: 11 Jan 2024
Estimated Primary Completion Date: 05 Sept 2025
Estimated Study Completion Date: 05 Sept 2025

Study design

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

Verification:

Verified 01 Sept 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria