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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

NCT07073950 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-05-11

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-24
Primary Completion
2027-05-31
Completion
2027-05-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07073950 on ClinicalTrials.gov