A study to investigate the effect of BGF MDI compared with placebo MDI on heart and lung function in participants with COPD

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AstraZeneca AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

6 Nov 2025 → ongoing

Decision date (initial)

2025-09-15

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AstraZeneca AB

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Therapy

The effect of BGF relative to placebo on LVEDVi in participants with COPD and hyperinflation will be evaluated

Secondary objectives 2

1. The effect of BGF relative to placebo on FRC/TLC will be evaluated.
2. The effect of BGF relative to placebo on RV/TLC will be evaluated.

Conditions and MedDRA coding

Chronic Obstructive Pulmonary Disease

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Current or former smoker with a history of ≥ 10 pack-years of tobacco smoking.
2. A diagnosis of COPD confirmed by a post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) < 0.7.
3. At Visit 1: A pre-bronchodilator FEV1 < 80%.
4. At Visit 1: Peripheral blood eosinophil count < 300 cells/cubic millimeter (mm³), with no recorded history of eosinophil count > 300 cells/mm³ in the past 12 months.
5. At Visit 1: Modified Medical Research Council (mMRC) ≥ 1.
6. At Visit 2: A pre-bronchodilator functional residual capacity (FRC) of > 135% of predicted normal FRC.
7. At Visit 2: A post-bronchodilator FEV1 ≥ 30% and < 80% of the predicted normal value.
8. Participants must be on mono-, dual-, or triple-inhaled maintenance COPD treatment.
9. Female participants must either be not of childbearing potential or using a form of highly effective birth control.
10. All women of child bearing potential must have a negative pregnancy test at the Visit 1.

Exclusion criteria 8

1. A current diagnosis of asthma, asthma-COPD overlap, or any other chronic respiratory disease other than COPD, such as alpha-1 antitrypsin deficiency, active tuberculosis, lung cancer, lung fibrosis, sarcoidosis, interstitial lung disease, and pulmonary hypertension.
2. History of a COPD exacerbation that required hospitalisation, or 2 or more COPD exacerbations that required systemic corticosteroids.
3. History of myocardial infarction or acute coronary syndrome.
4. History or current clinical significant atrial or ventricular arrhythmia to be confirmed by electrocardiogram (ECG).
5. Participants with a cardiac implantable electronic device, including pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy.
6. Participants with ECG QTcF interval at Visit 1 > 460 milliseconds (ms) for males and > 480 ms for females.
7. Participants who have had a respiratory tract infection within 8 weeks prior to Visit 1 and/or during the screening/run-in period.
8. Participants with lung lobectomy, lung volume reduction (during the study and within 3 months of Visit 1), or lung transplantation.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline in left ventricular end diastolic volume (LVEDVi) measured by magnetic resonance imaging (MRI).

Secondary endpoints 2

1. Change from baseline in functional residual capacity/total lung capacity (FRC/TLC) measured by body plethysmography.
2. Change from baseline in residual volume/total lung capacity (RV/TLC) measured by body plethysmography

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation

AstraZeneca AB

Address

-

City

Sodertalje

Postcode

151 85

Country

Sweden

Scientific contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Public contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Third parties 1

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications