Trials / Recruiting
RecruitingNCT07073950
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
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
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This is a Phase IV, randomised, double blind, multiple centre, placebo controlled, crossover study where the effectiveness of BGF MDI in comparison with matching placebo MDI on cardiac and lung function will be evaluated in patients with COPD and hyperinflation. The study will comprise of: * Screening period * Participants will receive placebo inhaler and salbutamol before randomization * Two treatment periods of 21 days each, where participants will be randomized 1:1 to receive either the study intervention BGF metered-dose inhaler (MDI) or placebo in Period 1 then crossover to matching placebo or BGF in Period 2 * A final follow-up period
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-11-24
- Primary completion
- 2027-05-31
- Completion
- 2027-05-31
- First posted
- 2025-07-20
- Last updated
- 2026-04-15
Locations
7 sites across 2 countries: Germany, United Kingdom
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07073950. Inclusion in this directory is not an endorsement.