A Study to Assess the Safety of Budesonide/Glycopyrronium/Formoterol Fumarate with the Hydrofluoroolefin Propellant in Participants with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Study identifier:D5985C00003

ClinicalTrials.gov identifier:NCT05573464

EudraCT identifier:2022-001476-33

CTIS identifier:N/A

Recruitment Complete

Official Title

A Randomized, Double-Blind, 12-Week (with an Extension to 52 Weeks in a subset of Participants), Multi-Center Study to Assess the Safety of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO Compared to BGF delivered by MDI HFA in Participants with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Medical condition

Chronic obstructive pulmonary disease (COPD)

Phase

Phase 3

Healthy volunteers

No

Study drug

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

Sex

All

Actual Enrollment

558

Study type

Interventional

Age

40 Years - 80 Years

Date

Study Start Date: 27 Sept 2022
Estimated Primary Completion Date: 21 Mar 2024
Estimated Study Completion Date: 21 Mar 2024

Study design

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

Verification:

Verified 01 Jan 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria