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)
NCT ID: NCT07073950
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
56 participants
INTERVENTIONAL
2025-11-24
2027-03-31
Brief Summary
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Detailed Description
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The study will comprise of:
* Screening period
* Participants will receive placebo inhaler and salbutamol before randomization
* Two treatment periods where participants will be randomized 1:1 to receive either the study intervention BGF MDI followed by matching placebo or study interventions in reverse order
* A final follow-up period
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Sequence 1: BGF MDI and Placebo
Participants will receive BGF MDI in Period 1 followed by Placebo in Period 2.
Budesonide/Glycopyrronium/Formoterol Fumarate
BGF will be administered as 2 inhalations via oral route of administration
Placebo
Matching placebo will be administered as 2 inhalations via oral route of administration
Metered dose inhaler
Participants will receive BGF and matching placebo via metered dose inhaler in treatment periods of the study.
Sequence 2: Placebo and BGF MDI
Participants will receive Placebo in Period 1 followed by BGF MDI in Period 2.
Budesonide/Glycopyrronium/Formoterol Fumarate
BGF will be administered as 2 inhalations via oral route of administration
Placebo
Matching placebo will be administered as 2 inhalations via oral route of administration
Metered dose inhaler
Participants will receive BGF and matching placebo via metered dose inhaler in treatment periods of the study.
Interventions
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Budesonide/Glycopyrronium/Formoterol Fumarate
BGF will be administered as 2 inhalations via oral route of administration
Placebo
Matching placebo will be administered as 2 inhalations via oral route of administration
Metered dose inhaler
Participants will receive BGF and matching placebo via metered dose inhaler in treatment periods of the study.
Eligibility Criteria
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Inclusion Criteria
* A diagnosis of COPD confirmed by a post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) \< 0.7.
* 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 eosinophil count \> 300 cells/mm³ in the past 12 months.
* At Visit 1: Modified Medical Research Council (mMRC) ≥ 1.
* At Visit 2: A pre-bronchodilator functional residual capacity (FRC) of \> 135% of predicted normal FRC.
* At Visit 2: A post-bronchodilator FEV1 ≥ 30% and \< 80% of the predicted normal value.
* Participants must be on mono-, dual-, or triple-inhaled maintenance COPD treatment.
* Female participants must either be not of childbearing potential or using a form of highly effective birth control.
* All women of child bearing potential must have a negative pregnancy test at the Visit 1.
Exclusion Criteria
* History of a COPD exacerbation that required hospitalisation, or 2 or more COPD exacerbations that required systemic corticosteroids.
* History of myocardial infarction or acute coronary syndrome.
* History or current atrial or ventricular arrhythmia to be confirmed by electrocardiogram (ECG).
* Participants with a cardiac implantable electronic device, including pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy.
* Participants with ECG QTcF interval at Visit 1 \> 460 milliseconds (ms) for males and \> 480 ms for females.
* Participants who have had a respiratory tract infection within 8 weeks prior to Visit 1 and/or during the screening/run-in period.
* Participants with lung lobectomy, lung volume reduction (during the study and within 3 months of Visit 1), or lung transplantation.
40 Years
80 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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AstraZeneca Clinical Study Information Center
Role: CONTACT
Phone: 1-877-240-9479
Email: [email protected]
Other Identifiers
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D5980C00048
Identifier Type: -
Identifier Source: org_study_id
2025-521987-37-00
Identifier Type: OTHER
Identifier Source: secondary_id