A Study to Evaluate the Effect of Budesonide, Glycopyrronium, Formoterol Fumarate (BGF) Metered Dose Inhaler (MDI), Budesonide and Formoterol Fumarate (BFF) MDI and Placebo MDI on Exercise Parameters in Participants With Chronic Obstructive Pulmonary Disease (COPD).
NCT ID: NCT06067828
Last Updated: 2025-12-19
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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ACTIVE_NOT_RECRUITING
PHASE3
171 participants
INTERVENTIONAL
2023-10-24
2026-01-30
Brief Summary
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Detailed Description
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Eligible participants will be randomized equally (1:1:1:1:1:1) to 1 of 6 treatment sequences. The total duration of the study for each participant will be up to 14 weeks.
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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BGF MDI
Pressurized MDI fixed combination product of Budesonide 160 μg, Glycopyrronium 7.2 μg, and Formoterol Fumarate 4.8 μg per actuation.
Treatment A : Budesonide, Glycopyrronium, and Formoterol Fumarate
Randomized participants will receive 2 inhalations of BGF MDI via oral inhalation twice daily (BID).
BFF MDI
Pressurized MDI fixed combination product of Budesonide 160 μg and Formoterol Fumarate 4.8 μg per actuation.
Treatment B: Budesonide and Formoterol Fumarate
Randomized participants will receive 2 inhalations of BFF MDI via oral inhalation BID.
Placebo
Placebo as pressurized inhalation suspension.
Treatment C : Placebo
Randomized participants will receive 2 inhalations of placebo MDI via oral inhalation BID.
Interventions
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Treatment A : Budesonide, Glycopyrronium, and Formoterol Fumarate
Randomized participants will receive 2 inhalations of BGF MDI via oral inhalation twice daily (BID).
Treatment B: Budesonide and Formoterol Fumarate
Randomized participants will receive 2 inhalations of BFF MDI via oral inhalation BID.
Treatment C : Placebo
Randomized participants will receive 2 inhalations of placebo MDI via oral inhalation BID.
Eligibility Criteria
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Inclusion Criteria
* Participant must have:
* a diagnosis of COPD confirmed by a post-bronchodilator Forced expiratory volume (FEV1)/ Forced vital capacity (FVC) \< 0.7 at Visit 1
* a post-bronchodilator FEV1 ≥ 30% and \<80% predicted normal (moderate to severe COPD) at Visit 1.
* a score of ≥ 2 on the modified Medical Research Council at Visit 1.
* pre-bronchodilator FRC of \> 120% of predicted normal FRC values at Visit 1.
* a constant work rate test endurance time of 3 to 8 minutes at Visit 2.
* Participant must be on a stable dose of mono-or dual inhaled maintenance COPD treatment for at least 6 weeks.
* Current or former smoker with a history of ≥ 10 pack-years of tobacco smoking
* Body mass index \< 40 kg/m2.
* Male and Female participants (not applicable for female participants with non-childbearing potential) and their partners must use an acceptable method of contraception.
Exclusion Criteria
* Historical or current evidence of a clinically significant disease
* Participants on oxygen therapy or that desaturate significantly (\<82%) during exercise.
* Participants who are enrolled or entering a pulmonary rehabilitation program during the study.
* Participants who have cancer that has not been in complete remission for at least 5 years.
* Participants with a diagnosis of narrow-angle glaucoma that has not been adequately treated and/or change in vision that may be relevant, in the opinion of the investigator.
* Participants with symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that, in the opinion of the investigator, is clinically significant.
* Participants who have a history of hypersensitivity to β2-agonists, budesonide or any other corticosteroid components, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI or dry powder inhaler.
* Participant with resting (5 minutes) oxygen saturation SaO2 in room air ≤ 85%.
* A COPD exacerbation that requires hospitalization within 12 months prior to Visit 1 or a COPD exacerbation that requires systemic corticosteroids or antibiotics within 4 months of Visit 1.
* Participants with contraindications to cardiopulmonary exercise testing (CPET).
* Participants who have had a respiratory tract infection within 8 weeks prior to Visit 1 and/or during the screening period.
* Participants with lung lobectomy, lung volume reduction or lung transplantation.
* Unable to withhold short-acting bronchodilators for 6 hours prior to lung function testing at each study visit.
* Known history of drug or alcohol abuse within 12 months.
* Any regular recreational use of marijuana in the 12 months.
40 Years
80 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Seoul, , South Korea
Research Site
Benalmádena, , Spain
Research Site
Madrid, , Spain
Research Site
Santiago de Compostela, , Spain
Research Site
Seville, , Spain
Research Site
Leicester, , United Kingdom
Research Site
London, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Manchester, , United Kingdom
Research Site
Los Angeles, California, United States
Research Site
Tarzana, California, United States
Research Site
Torrance, California, United States
Research Site
Brooksville, Florida, United States
Research Site
Anderson, South Carolina, United States
Research Site
Greenville, South Carolina, United States
Research Site
Spartanburg, South Carolina, United States
Research Site
Edmonton, Alberta, Canada
Research Site
Kingston, Ontario, Canada
Research Site
Sainte-Foy, Quebec, Canada
Research Site
Guangzhou, , China
Research Site
Nanchang, , China
Research Site
Shenyang, , China
Research Site
Zhengzhou, , China
Research Site
Berlin, , Germany
Research Site
Berlin, , Germany
Research Site
Frankfurt, , Germany
Research Site
Großhansdorf, , Germany
Research Site
Hanover, , Germany
Research Site
Heidelberg, , Germany
Research Site
Lübeck, , Germany
Research Site
Mainz, , Germany
Research Site
Daegu, , South Korea
Research Site
Seoul, , South Korea
Countries
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Other Identifiers
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D5988C00001
Identifier Type: -
Identifier Source: org_study_id