A Study to Investigate the Effect on Lung Function of an Approved COPD Treatment (BGF, With HFA Propellant) Compared to BGF Formulated With a Next-Generation Propellant in Participants 40 to 80 Years of Age With COPD
A Randomised, Placebo-Controlled, Double-Blind, Multi-Centre, 4-week, 3-way Crossover Pharmacodynamic Study to Assess the Equivalence of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO Compared With BGF Delivered by MDI HFA in Participants With Chronic Obstructive Pulmonary Disease
2 other identifiers
interventional
297
14 countries
87
Brief Summary
The purpose of this study is to demonstrate that the lung function effect from orally inhaled BGF delivered via HFO propellant is equivalent to the lung function effect from orally inhaled BGF delivered via HFA propellant in participants with COPD. The study duration for each participant will be approximately 15 to 16 weeks and consist of:
- 1.A screening and placebo run-in period of approximately 2 weeks prior to first dosing
- 2.Three treatment periods of approximately 4 weeks each (one period for each of 3 study interventions)
- 3.A final safety follow-up visit via telephone contact approximately 1 to 2 weeks after the final dose administration Participants will be provided with rescue SABA (albuterol or salbutamol) to be used as needed throughout the study. Participants will attend in-clinic study visits approximately weekly during the screening/run-in period (Visits 1, 2, and 3), then every 4 weeks (Visits 4, 5, and 6) to receive take-home study treatment, measure their lung function, and assess their health and safety
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2024
87 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2023
CompletedFirst Posted
Study publicly available on registry
October 10, 2023
CompletedStudy Start
First participant enrolled
January 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2025
CompletedAugust 27, 2025
August 1, 2025
1.6 years
October 4, 2023
August 26, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Changes in FEV1 AUC (0-4)
To assess the equivalence of BGF MDI HFO relative to BGF MDI HFA on lung function in participants with COPD
Change from baseline at Day 29
Change in morning pre-dose trough FEV1
To assess the equivalence of BGF MDI HFO relative to BGF MDI HFA on lung function in participants with COPD
Change from baseline at Day 29
Changes in FEV1 AUC (0-4)
To demonstrate assay sensitivity via superiority of BGF MDI HFA relative to placebo MDI HFA on lung function in participants with COPD
Change from baseline at Day 29
Change in morning pre-dose trough FEV1
To demonstrate assay sensitivity via superiority of BGF MDI HFA relative to placebo MDI HFA on lung function in participants with COPD
Change from baseline at Day 29
Other Outcomes (7)
Number (and percentage) of participants with adverse Events
Over 16 weeks and per treatment group per 4 weeks treatment period
Number (and percentage) of participants with with potentially clinically significant changes in Blood Pressure
Over 16 weeks and per treatment group per 4 weeks treatment period
Number (and percentage) of participants with potentially clinically significant changes in pulse rate
Over 16 weeks and per treatment group per 4 weeks treatment period
- +4 more other outcomes
Study Arms (6)
Treatment Sequence 1
EXPERIMENTALEach participant will participate in 3 treatment periods of approximately 4 weeks each (one period for each of 3 study interventions) in the following sequence. Sequence 1: BGF MDI HFO 320/14.4/9.6 μg BGF MDI HFA 320/14.4/9.6 μg Placebo MDI HFA
Treatment Sequence 2
EXPERIMENTALEach participant will participate in 3 treatment periods of approximately 4 weeks each (one period for each of 3 study interventions) in the following sequence. Sequence 2: BGF MDI HFO 320/14.4/9.6 μg Placebo MDI HFA BGF MDI HFA 320/14.4/9.6 μg
Treatment Sequence 3
EXPERIMENTALEach participant will participate in 3 treatment periods of approximately 4 weeks each (one period for each of 3 study interventions) in the following sequence. Sequence 3: BGF MDI HFA 320/14.4/9.6 μg BGF MDI HFO 320/14.4/9.6 μg Placebo MDI HFA
Treatment Sequence 4
EXPERIMENTALEach participant will participate in 3 treatment periods of approximately 4 weeks each (one period for each of 3 study interventions) in the following sequence. Sequence 4: BGF MDI HFA 320/14.4/9.6 μg Placebo MDI HFA BGF MDI HFO 320/14.4/9.6 μg
Treatment Sequence 5
EXPERIMENTALEach participant will participate in 3 treatment periods of approximately 4 weeks each (one period for each of 3 study interventions) in the following sequence. Sequence 5: Placebo MDI HFA BGF MDI HFO 320/14.4/9.6 μg BGF MDI HFA 320/14.4/9.6 μg
Treatment Sequence 6
EXPERIMENTALEach participant will participate in 3 treatment periods of approximately 4 weeks each (one period for each of 3 study interventions in the following sequence. Sequence 6: Placebo MDI HFA BGF MDI HFA 320/14.4/9.6 μg BGF MDI HFO 320/14.4/9.6 μg
Interventions
Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart)
Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart):
Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart)
Eligibility Criteria
You may qualify if:
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Age
- Participants must be 40 to 80 years inclusive at the time of signing the ICF. Type of Participant and Disease Characteristics
- Participants who have a documented history of physician-diagnosed COPD as defined by the ATS/ERS (Celli et al 2004).
- Participants who have been receiving LABA, LAMA, LAMA/LABA, or ICS/LABA inhaled maintenance therapies for the management of their COPD for at least 4 weeks prior to Visit 1, OR Participants who have been receiving SABA, SAMA, or SABA/SAMA either scheduled or as needed for at least 4 weeks prior to Visit 1, OR Participants who are COPD treatment-naïve or have not received previously prescribed COPD treatment in the 4 weeks prior to Visit 1.
- At Visit 1: Participants with a blood eosinophil count \< 300 cells/μL.
- At Visit 1: Participants with a pre-bronchodilator FEV1 of \< 80% predicted normal.
- At Visit 2: Participants with a post-bronchodilator FEV1/FVC ratio of \< 0.70 and a postbronchodilator FEV1 of ≥ 40% to \< 80% predicted normal.
- At Visit 3 (TP 1 Day 1): Participants with a pre-dose FEV1 of \< 80% predicted normal that is within ± 20% or 200 mL of their Visit 2 pre-bronchodilator FEV1 and an FEV1/FVC ratio of \< 0.70.
- Current or former smokers with a history of at least 10 pack-years of tobacco smoking
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- pack-year = 20 cigarettes smoked per day for one year). 9 Participants who are willing and, in the opinion of the Investigator, able to adjust current COPD therapy, as required by the protocol. Sex and Contraceptive/Barrier Requirements 10 Females must not be of childbearing potential or must use a form of highly effective birth control as defined below:
- Females not of childbearing potential are defined as females who are either permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or postmenopausal. Females will be considered postmenopausal if they have been amenorrhoeic for 52 weeks (12 months) prior to the planned date of randomisation without an alternative medical cause. The following age-specific requirements apply:
- Females \< 50 years old would be considered postmenopausal if they have been amenorrhoeic for 52 weeks (12 months) or more following cessation of exogenous hormonal treatment with FSH levels in the postmenopausal range.
- Females ≥ 50 years old would be considered postmenopausal if they have been amenorrhoeic for 52 weeks (12 months) or more following cessation of all exogenous hormonal treatment.
- +19 more criteria
You may not qualify if:
- Medical Conditions
- Confirmed diagnosis of asthma, in the opinion of the Investigator based on thorough review of medical history and medical records.
- COPD due to α1-antitrypsin deficiency.
- A COPD exacerbation treated with systemic corticosteroids or antibiotics within 4 months prior to Visit 1 or during the Screening Period.
- A COPD exacerbation that required hospitalisation within 12 months prior to Visit 1 or during the Screening Period.
- A respiratory infection ending within 4 weeks prior to Visit 1 or beginning or ending during the Screening Period, per the Investigator's judgement.
- Life-threatening COPD (eg, need for mechanical ventilation) at any time prior to Visit 1 or during the Screening Period.
- A SARS-CoV-2 infection in the 8 weeks prior to Visit 1 or during the Screening Period, or that required hospitalisation at any time prior to Visit 1 or during the Screening Period.
- Sleep apnoea that, in the opinion of the Investigator, is uncontrolled.
- Other respiratory disorders including, but not limited to, known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis (high-resolution CT evidence of bronchiectasis that causes repeated acute exacerbations), severe neurological disorders affecting control of the upper airway, sarcoidosis, primary ciliary dyskinesia, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or pulmonary thromboembolic disease.
- Significant or unstable ischaemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the Investigator, or any other relevant cardiovascular disorder as judged by the Investigator.
- Diagnosis of narrow-angle glaucoma that has not been adequately treated, or a change in vision that may be relevant, in the opinion of the Investigator.
- Note: All medications approved for control of intraocular pressures are allowed, including topical ophthalmic nonselective beta-blockers and prostaglandin analogues.
- Symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that, in the opinion of the Investigator, is clinically significant.
- Unresectable cancer that has not been in complete remission for at least 5 years prior to Visit 1. Note: Squamous cell and basal cell carcinomas of the skin are allowed.
- +24 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (87)
Research Site
Sheffield, Alabama, 35660, United States
Research Site
Clearwater, Florida, 33765, United States
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Gainesville, Florida, 32605, United States
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Miami, Florida, 33175, United States
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Orlando, Florida, 32825, United States
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Tampa, Florida, 33606, United States
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Rincon, Georgia, 31326, United States
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Chicago, Illinois, 60607, United States
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Saint Charles, Missouri, 63301, United States
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St Louis, Missouri, 63141, United States
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The Bronx, New York, 10455, United States
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Raleigh, North Carolina, 27607, United States
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Dublin, Ohio, 43016, United States
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Medford, Oregon, 97504, United States
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Portland, Oregon, 97202, United States
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Philadelphia, Pennsylvania, 19114, United States
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Gaffney, South Carolina, 29340, United States
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Boerne, Texas, 78006, United States
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El Paso, Texas, 79912, United States
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Buenos Aires, C1414AIF, Argentina
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Buenos Aires, C1425BEN, Argentina
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Quilmes, B1878FNR, Argentina
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Rosario, 2000, Argentina
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San Fernando, B1646EBJ, Argentina
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Burgas, 8000, Bulgaria
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Pernik, 2300, Bulgaria
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Pleven, 5800, Bulgaria
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Plovdiv, 4002, Bulgaria
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Sofia, 1202, Bulgaria
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Sofia, 1756, Bulgaria
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Varna, 9000, Bulgaria
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Veliko Tarnovo, 5000, Bulgaria
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Vratsa, 3000, Bulgaria
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Truro, Nova Scotia, B2N 1L2, Canada
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Burlington, Ontario, L7N 3V2, Canada
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Guelph, Ontario, N1H 6J2, Canada
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Québec, Quebec, G1W 4R4, Canada
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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
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Balassagyarmat, 2660, Hungary
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Hajdúnánás, 4080, Hungary
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Mosonmagyaróvár, 9200, Hungary
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Pécs, 7635, Hungary
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Püspökladány, 4150, Hungary
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Ajmer, 305001, India
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Aligarh, 202002, India
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Coimbatore, 641028, India
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Jaipur, 302039, India
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Kanpur, 208002, India
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Surat, 395009, India
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George Town, 10450, Malaysia
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Ipoh, 30990, Malaysia
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Kuala Lumpur, 50586, Malaysia
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Kuala Terengganu, 20400, Malaysia
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Benito Juárez, 03650, Mexico
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Chihuahua City, 31200, Mexico
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Cuernavaca, 62290, Mexico
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Monterrey, 64465, Mexico
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Zapopan, 45138, Mexico
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Iloilo City, 5000, Philippines
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Las Piñas, 1742, Philippines
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Quezon City, 1000, Philippines
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Bialystok, 15-044, Poland
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Chęciny, 26-060, Poland
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Lublin, 20-601, Poland
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Daegu, 42415, South Korea
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Jeonju, 54907, South Korea
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Seoul, 04763, South Korea
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Seoul, 06591, South Korea
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Ulsan, 44033, South Korea
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Chiang Mai, 50200, Thailand
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Hat Yai, 90110, Thailand
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Khon Kaen, 40002, Thailand
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Muang, 22000, Thailand
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Ankara, 06620, Turkey (Türkiye)
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Dinar, 03400, Turkey (Türkiye)
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Istanbul, 34020, Turkey (Türkiye)
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Istanbul, 34722, Turkey (Türkiye)
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Izmir, 35110, Turkey (Türkiye)
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Izmir, 35965, Turkey (Türkiye)
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Kayseri, 38030, Turkey (Türkiye)
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Can Tho, 900000, Vietnam
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Da Nang, 550000, Vietnam
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Haiphong, 180000, Vietnam
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Hanoi, 10000, Vietnam
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Hà Nội, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Hochiminh, 70000, Vietnam
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2023
First Posted
October 10, 2023
Study Start
January 11, 2024
Primary Completion
August 12, 2025
Study Completion
August 12, 2025
Last Updated
August 27, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.