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RECRUITING
NCT07073950
PHASE4

A Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate the effect of BGF MDI compared with placebo MDI on cardiac and lung function when administered in participants diagnosed with COPD and hyperinflation.

Official title: A Randomised, Double-blind, Multi-centre, Placebo-controlled, Crossover Study to Assess the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler on Cardiac and Lung Function in Participants With Chronic Obstructive Pulmonary Disease and Hyperinflation

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2025-11-24

Completion Date

2027-05-31

Last Updated

2026-03-19

Healthy Volunteers

No

Interventions

DRUG

Budesonide/Glycopyrronium/Formoterol Fumarate

BGF will be administered as 2 inhalations via oral route of administration

DRUG

Placebo

Matching placebo will be administered as 2 inhalations via oral route of administration

DEVICE

Metered dose inhaler

Participants will receive BGF and matching placebo via metered dose inhaler in treatment periods of the study.

Locations (6)

Research Site

Ahrensburg, Germany

Research Site

Berlin, Germany

Research Site

Hanover, Germany

Research Site

Harefield, United Kingdom

Research Site

London, United Kingdom

Research Site

Manchester, United Kingdom