A Study to Evaluate the Effect of Budesonide, Glycopyrronium, Formoterol fumarate (BGF) metered dose inhaler (MDI), Budesonide and Formoterol Fumarate (BFF) MDI and Placebo MDI on Exercise Parameters in Participants with Chronic Obstructive Pulmonary Disease (COPD). - ATHLOS

Study identifier:D5988C00001

ClinicalTrials.gov identifier:NCT06067828

EudraCT identifier:N/A

CTIS identifier:2022-502274-16-00

Recruiting

Official Title

A Double-Blind, Multicentre, Randomized, Three-Period, Three-Treatment, Cross-Over Study to Evaluate the Effect of BGF MDI, BFF MDI, and Placebo MDI on Exercise Parameters in Participants with COPD (ATHLOS)

Medical condition

Chronic Obstructive Pulmonary Disease

Phase

Phase 3

Healthy volunteers

No

Study drug

Treatment A : Budesonide, Glycopyrronium, and Formoterol Fumarate, Treatment B: Budesonide and Formoterol Fumarate, Treatment C : Placebo

Sex

All

Estimated Enrollment

180

Study type

Interventional

Age

40 Years - 80 Years

Date

Study Start Date: 24 Oct 2023
Estimated Primary Completion Date: 24 Aug 2025
Estimated Study Completion Date: 25 Aug 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