At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Budesonide/Glycopyrronium/Formoterol Fumarate (drug), Placebo (drug), Metered dose inhaler (device)
- How long the study runs
- Study runs about 18 months (dates as stated)
- About the drug or intervention
- Budesonide/Glycopyrronium/Formoterol Fumarate — drug: BGF will be administered as 2 inhalations via oral route of administration · Placebo — drug: Matching placebo will be administered as 2 inhalations via oral route of administration · Metered dose inhaler — device: Participants will receive BGF and matching placebo via metered dose inhaler in treatment periods of the study.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 40 Years to 80 Years
- Who
- All
- Number of participants
- 56
- Started
- 2025-11-24
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for chronic obstructive pulmonary disease
- • Phase4 - 56 participants
- • 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
Who can take part?
- • Ages 40 Years to 80 Years
- • Diagnosed with chronic obstructive pulmonary disease
Where?
- • Harefield - Research Site
- • London - Research Site
- • Manchester - Research Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 40 Years - 80 Years
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ a negative pregnancy test at the Visit 1
What the study is looking for
- ✓Current or former smoker with a history of ≥ 10 pack-years of tobacco smoking.
- ✓A diagnosis of COPD confirmed by a post-bronchodilator forced expiratory volume in 1 second/forced vital capacity...
- ✓At Visit 1: A pre-bronchodilator FEV1 \< 80%.
- ✓At Visit 1: Peripheral blood eosinophil count \< 300 cells/cubic millimeter (mm³), with no recorded history of...
- ✓At Visit 1: Modified Medical Research Council (mMRC) ≥ 1.
Who cannot take part
- ✗History of a COPD exacerbation that required hospitalisation, or 2 or more COPD exacerbations that required systemic...
- ✗History of myocardial infarction or acute coronary syndrome.
- ✗History or current clinically significant atrial or ventricular arrhythmia to be confirmed by electrocardiogram (ECG).
- ✗Participants with a heart implantable electronic device, including pacemaker, implantable cardioverter...
- ✗Participants with ECG QTcF interval at Visit 1 \> 460 milliseconds (ms) for males and \> 480 ms for females.
See the full criteria
Where Is This Study? (3 UK sites)
Research Site
Harefield UB9 6JH, United Kingdom
Research Site
London W1T 6AH, United Kingdom
Research Site
Manchester M23 9QZ, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
