Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT05573464
A Study to Assess the Safety of Budesonide/Glycopyrronium/Formoterol Fumarate With a Next-Generation Propellant in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
A Phase 3 study testing BGF MDI HFO 320/14.4/9.6 μg and BGF MDI HFA 320/14.4/9.6 μg in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 91 sites in 9 countries.
Trial summary
This is a 12-week (with an extension to 52 weeks in a subset of participants) study comparing the safety of BGF MDI HFO twice daily (BID) with BGF MDI HFA BID in participants with moderate to very severe COPD. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- BGF MDI HFO 320/14.4/9.6 μg and BGF MDI HFA 320/14.4/9.6 μg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 559 participants
- Where
- 91 sitesin 9 countries
- Study dates
- 27 Sep 2022to 26 Mar 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be 40 to 80 years of age inclusive, at the time of signing the ICF;
- Participants who have a documented history of physician-diagnosed COPD as defined by the ATS/ERS (Celli et al 2004) or by locally applicable guidelines;
- Participants who have been regularly using dual ICS/LABA, LAMA/LABA, or ICS/LAMA/LABA (open or fixed-dose combinations) inhaled maintenance therapies for the management of their COPD for at least 6 weeks prior to Screening;
- Participants who have pre-bronchodilator FEV1 of < 80% predicted normal at Visit 1;
- Participants who have post-bronchodilator FEV1/FVC ratio of < 0.70 and post-bronchodilator FEV1 of ≥ 25% to < 80% predicted normal at Visit 2;
- Participants who have CAT score ≥ 10 at Visit 1;
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- Participants who are current/former smokers with a history of at least 10 pack-years of tobacco smoking (1 pack year = 20 cigarettes smoked per day for 1 year);
- Participants who are willing and, in the opinion of the Investigator, able to adjust current COPD therapy, as required by the protocol;
- Participants must be able to demonstrate acceptable MDI administration and spirometry technique;
- Participants who are willing to remain at the study center as required per protocol to complete all visit assessments;
- Females must either be not of childbearing potential, or using a form of highly effective birth control as defined below:
- Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrhoeic for 52 weeks (12 months) prior to the planned date of randomization without an alternative medical cause. The following age-specific requirements apply:
- Women < 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 and follicle stimulating hormone levels in the postmenopausal range.
- Women ≥ 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.
- Female participants of childbearing potential must use one highly effective form of birth control. A highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. At enrollment, women of childbearing potential who are sexually active with a non-sterilized male partner should be stable on their chosen method of highly effective birth control, as defined below, and willing to remain on the birth control until at least 14 days after last dose of study intervention. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception. Female condom and male condom should not be used together.
- All women of childbearing potential must have a negative serum pregnancy test result at Visit 1
- Women <50 years of age with amenorrhea for 12 months without an alternative medical cause must have a serum LH and FSH test (within 21-28 days before Visit 3) for study eligibility
- Highly effective birth control methods are listed below:
- Sexual abstinence defined as complete abstinence from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
- Oral
- Intravaginal
- Transdermal
- Progestogen-only hormonal contraception associated with inhibition of ovulation:
- Oral
- Injectable
- Implantable
- Intrauterine device or intrauterine hormone-releasing system
- Male partner sterilization/vasectomy with documentation of azoospermia prior to the female participant's entry into the study, and this male is the sole partner for that participant. The documentation on male sterility can come from the site personnel's review of participant's medical records, medical examination and/or semen analysis or medical history interview provided by her or her partner.
- Bilateral tubal ligation
- Capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
Who cannot join
- Participants who have a documented history of physician-diagnosed asthma in the opinion of the Investigator based on thorough review of medical history and medical records, within 5 years of Visit 1;
- Participants who have COPD due to α1-Antitrypsin Deficiency;
- Participants with historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neurological, endocrine, gastrointestinal, or pulmonary. Significant is defined as any uncontrolled disease or any disease that, in the opinion of the Investigator, would put the safety of the participant at risk through participation, or that could affect the efficacy or safety analyses;
- Sleep apnea that, in the opinion of the Investigator, cannot be controlled;
- Other respiratory disorders including known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis (high resolution CT evidence of bronchiectasis that causes repeated acute exacerbations), immune deficiency disorders, severe neurological disorders affecting control of the upper airway, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or pulmonary thromboembolic disease;
- Participant with moderate or severe COPD exacerbation or respiratory infection ending within 4 weeks prior to Visit 1 or during the Screening period;
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- Participant who has had a SARS-CoV-2 infection in the 8 weeks prior to Visit 1 or during the Screening Period or that required hospitalization at any time prior to Visit 1 or during the Screening Period;
- Pulmonary resection or lung volume reduction surgery during the 26 weeks (6 months) prior to Visit 1 (ie, lobectomy, bronchoscopy lung volume reduction [endobronchial blockers, airway bypass, endobronchial valves, thermal vapor ablation, biological sealants, and airway implants]);
- Long-term oxygen therapy;
- Imminent life-threatening COPD (eg, need for mechanical ventilation);
- Participant who has significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the Investigator, or any other relevant cardiovascular disorder as judged by the Investigator;
- Participant with narrow angle glaucoma not adequately treated and/or 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 analogs.
- Symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that, in the opinion of the Investigator, is clinically significant; Note: Participants with trans-urethral resection of prostate or full resection of the prostate within 26 weeks (6 months) prior to Visit 1 are excluded from the study
- 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 not exclusionary
- Known history of drug or alcohol abuse within 52 weeks (12 months) of Visit 1;
- Unable to withhold short-acting bronchodilators for 6 hours prior to lung function testing at each applicable study visit;
- Participant is unable to abstain from protocol-defined prohibited medications during Screening and Treatment Periods;
- Using any herbal products either by inhalation or nebulizer within 2 weeks of Visit 1 and does not agree to stop for the duration of the study;
- Participants with a known hypersensitivity to beta2-agonists, muscarinic antagonists, or corticosteroids, or any component of the MDI;
- Participation in another clinical study with an intervention administered in the last 30 days or 5 half-lives, whichever is longer;
- Previous randomization in any study using BGF MDI HFO (budesonide/glycopyrronium/formoterol fumarate - HFO);
- Participants with calculated eGFR ≤ 30 mL/minute/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula;
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, vital signs, or ECG, which in the opinion of the Investigator, may put the participant at risk because of his/her participation in the study; Note: Participants with ECG QTcF interval (corrected for heart rate using Fridericia's formula [QTcF]) > 480 msec will be excluded. Participants with high degree atrioventricular block II or III, or with sinus node dysfunction with clinically significant pauses who are not treated with pacemaker will also be excluded.
- Planned hospitalization during the study;
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site);
- Study Investigators, sub-Investigators, coordinators, and their employee or immediate family members;
- Judgment by the Investigator that the participant is unlikely to comply with study procedures, restrictions and requirements;
- For women only - currently pregnant (confirmed with positive pregnancy test), breast feeding, or planned pregnancy during the study or women of childbearing potential not using acceptable contraception measures (see Inclusion criterion 12 in Section 5.1).
Trial locations and contacts
91 sites in 9 countries.
91 sites in 9 countries
United States20 sites
Research Site
Anderson, South Carolina, 29621
Research Site
Charlotte, North Carolina, 28209
Research Site
Columbia, South Carolina, 29204
Research Site
Crowley, Louisiana, 70526
Research Site
Dublin, Ohio, 43016
Research Site
Gaffney, South Carolina, 29340
Research Site
Grants Pass, Oregon, 97527
Research Site
Longview, Texas, 75605
Research Site
McKinney, Texas, 75069
Research Site
Miami, Florida, 33175
Research Site
Newport Beach, California, 92663
Research Site
North Dartmouth, Massachusetts, 02747
Research Site
Phoenix, Arizona, 85032
Research Site
Portland, Oregon, 97202
Research Site
Richmond, Virginia, 23219
Research Site
Sarasota, Florida, 34239
Research Site
St Louis, Missouri, 63141
Research Site
Tampa, Florida, 33606
Research Site
Valparaiso, Indiana, 46383
Research Site
Wilmington, North Carolina, 28401
Germany20 sites
Research Site
Berlin, 10629
Research Site
Berlin, 10787
Research Site
Berlin, 10969
Research Site
Berlin, 12159
Research Site
Berlin, 13156
Research Site
Dresden, 01069
Research Site
Elsterwerda, 04910
Research Site
Essen, 45359
Research Site
Halle, 06108
Research Site
Hamburg, 20253
Research Site
Hanover, 30159
Research Site
Hanover, 30449
Research Site
Hanover, D-30173
Research Site
Karlsruhe, 76137
Research Site
Koblenz, 56068
Research Site
Magdeburg, 39120
Research Site
Rheine, 48431
Research Site
Schwerin, 19055
Research Site
Wiesbaden, 65189
Research Site
Witten, 58452
Poland12 sites
Research Site
Będzin, 42-500
Research Site
Bydgoszcz, 85-231
Research Site
Grodzisk Mazowiecki, 05-825
Research Site
Inowrocław, 88-100
Research Site
Jelenia Góra, 58-506
Research Site
Krakow, 31-011
Research Site
Lodz, 91-053
Research Site
Lublin, 20-412
Research Site
Piaseczno, 05-500
Research Site
Skórzewo, 60-185
Research Site
Szczecin, 70-111
Research Site
Zamość, 22-400
Canada10 sites
Research Site
Ajax, Ontario, L1S 2J5
Research Site
Burlington, Ontario, L7N 3V2
Research Site
Guelph, Ontario, N1H 6J2
Research Site
Montreal, Quebec, H1Y 3H5
Research Site
Québec, Quebec, G1G 3Y8
Research Site
Québec, Quebec, G1V 4G5
Research Site
Québec, Quebec, G2J 0C4
Research Site
Saint-Charles-Borromée, Quebec, J6E 2B4
Research Site
Trois-Rivières, Quebec, G8T 7A1
Research Site
Truro, Nova Scotia, B2N 1L2
Bulgaria9 sites
Research Site
Blagoevgrad, 2700
Research Site
Dupnitsa, 2602
Research Site
Lom, 3600
Research Site
Pernik, 2300
Research Site
Sandanski, 2800
Research Site
Sevlievo, 5400
Research Site
Sofia, 1618
Research Site
Veliko Tarnovo, 5000
Research Site
Vidin, 3700
Argentina5 sites
Research Site
Buenos Aires, C1414AIF
Research Site
Buenos Aires, C1425BEN
Research Site
Quilmes, B1878FNR
Research Site
Rosario, S2000DEJ
Research Site
San Fernando, B1646EBJ
Mexico5 sites
Research Site
Cuernavaca, 62290
Research Site
Culiacán, 80200
Research Site
Mérida, 97130
Research Site
México, 03300
Research Site
Monterrey, 64020
Turkey (Türkiye)5 sites
Research Site
Ankara, 06620
Research Site
Istanbul, 34020
Research Site
Izmir, 35110
Research Site
Mersin, 33343
Research Site
Pamukkale, 20070
United Kingdom5 sites
Research Site
Blackpool, FY3 7EN
Research Site
Corby, NN17 2UR
Research Site
Liverpool, L1 9ED
Research Site
Poole, BH15 2HX
Research Site
Thetford, IP24 1JD
About this study
Official title: A Randomized, Double-Blind, 12-Week (With an Extension to 52 Weeks in a Subset of Participants), Multi-Center Study to Assess the Safety of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO Compared to BGF Delivered by MDI HFA in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
This is a 12-week (with an extension to 52 weeks in a subset of participants) study comparing the safety of BGF MDI HFO twice daily (BID) with BGF MDI HFA BID in participants with moderate to very severe COPD.
Read the detailed description
This is a Phase 3 randomized, double-blind, 12-week (with an extension to 52 weeks in a subset of participants) study comparing the safety of BGF MDI HFO 320/14.4/9.6 μg twice daily (BID) with BGF MDI HFA 320/14.4/9.6 μg BID in participants with moderate to very severe COPD. For the 12-week study, 542 participants will be randomized to treatments BGF MDI HFO and BGF MDI HFA in a 1:1 ratio. Randomization will be stratified by region (Americas, Europe) and COPD disease severity (percent predicted FEV1 ≥ 50%, percent predicted FEV1 < 50%). Subsequently, the 120 participants per treatment arm who were randomized to the extended study will continue and remain on the randomized treatment to 52 weeks.
- Being tested
- BGF MDI HFO 320/14.4/9.6 μg, BGF MDI HFA 320/14.4/9.6 μg
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGF MDI HFO 320/14.4/9.6 μgDrug
Also called BGF MDI HFO
Budesonide, Glycopyrronium, and Formoterol Fumarate
BGF MDI HFA 320/14.4/9.6 μgDrug
Also called BGF MDI HFA
Budesonide, Glycopyrronium, and Formoterol Fumarate
| Study group | Role | What they receive |
|---|---|---|
| BGF MDI HFO 320/14.4/9.6μg | Experimental | Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO (HFO-1234ze) Receives: Drug: BGF MDI HFO 320/14.4/9.6 μg |
| BGF MDI HFA 320/14.4/9.6 μg | Active comparator | Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFA Receives: Drug: BGF MDI HFA 320/14.4/9.6 μg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Percentage of Participants With Serious Adverse Events
To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD
Measured: Over 12 weeks
Number and Percentage of Participants With Serious Adverse Events
To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD
Measured: Over 52 weeks
Number and Percentage of Participants With Non-serious Adverse Events >5%
To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD
Measured: Over 12 weeks
Number and Percentage of Participants With Non-serious Adverse Events >5%
To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD
Measured: Over 52 weeks
Number and Percentage of Participants With Adverse Events of Special Interest
To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD. Adverse events of special interest in this study are respiratory events such as dysphonia, cough, dyspnea, wheezing, paradoxical bronchospasm, bronchospasm, and COPD exacerbations.
Measured: Over 12 weeks
Number and Percentage of Participants With Adverse Events of Special Interest
To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD. Adverse events of special interest in this study are respiratory events such as dysphonia, cough, dyspnea, wheezing, paradoxical bronchospasm, bronchospasm, and COPD exacerbations.
Measured: Over 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start27 Sep 2022
- Primary completion26 Mar 2024
- Study completion26 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 559 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573464
- Sponsor's protocol ID
- D5985C00003
- Other IDs
- 2022-001476-33
- Status last verified
- Aug 2025
- First submitted
- 19 Sep 2022
- Last updated
- 19 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Usmani OS, Martinez FJ, Pandya H, Camiolo M, Bednarczyk A, Kucz K, Kokot M, Gottfridsson C, Aurivillius M, Pettersson L, Mei J, Skansen K, Bell JL, Petullo D, Collison K, Bondarov P, Jassal M, Patel M. Safety of budesonide/glycopyrronium/formoterol fumarate dihydrate delivered by HFO-1234ze versus HFA-134a in chronic obstructive pulmonary disease: a phase 3, multi-site, randomised, double-blind, parallel-group, active-comparator study. EClinicalMedicine. 2025 Aug 12;87:103402. doi: 10.1016/j.eclinm.2025.103402. eCollection 2025 Sep.
PubMed 40831469
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, 12-Week (With an Extension to 52 Weeks in a Subset of Participants), Multi-Center Study to Assess the Safety of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO Compared to BGF Delivered by MDI HFA in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT05573464
- Acronym / sponsor ID
- D5985C00003
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 559 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 26 Mar 2024 (actual)
- Study completion
- 26 Mar 2024 (actual)
- First posted
- 10 Oct 2022 (actual)
- Results
- Posted 19 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 12-week (with an extension to 52 weeks in a subset of participants) study comparing the safety of BGF MDI HFO twice daily (BID) with BGF MDI HFA BID in participants with moderate to very severe COPD.
Detailed description
This is a Phase 3 randomized, double-blind, 12-week (with an extension to 52 weeks in a subset of participants) study comparing the safety of BGF MDI HFO 320/14.4/9.6 μg twice daily (BID) with BGF MDI HFA 320/14.4/9.6 μg BID in participants with moderate to very severe COPD. For the 12-week study, 542 participants will be randomized to treatments BGF MDI HFO and BGF MDI HFA in a 1:1 ratio. Randomization will be stratified by region (Americas, Europe) and COPD disease severity (percent predicted FEV1 ≥ 50%, percent predicted FEV1 < 50%). Subsequently, the 120 participants per treatment arm who were randomized to the extended study will continue and remain on the randomized treatment to 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BGF MDI HFO 320/14.4/9.6μg | Experimental | Drug: BGF MDI HFO 320/14.4/9.6 μgBudesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO (HFO-1234ze) |
| BGF MDI HFA 320/14.4/9.6 μg | Active comparator | Drug: BGF MDI HFA 320/14.4/9.6 μgBudesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFA |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Participant must be 40 to 80 years of age inclusive, at the time of signing the ICF;
- Participants who have a documented history of physician-diagnosed COPD as defined by the ATS/ERS (Celli et al 2004) or by locally applicable guidelines;
- Participants who have been regularly using dual ICS/LABA, LAMA/LABA, or ICS/LAMA/LABA (open or fixed-dose combinations) inhaled maintenance therapies for the management of their COPD for at least 6 weeks prior to Screening;
- Participants who have pre-bronchodilator FEV1 of < 80% predicted normal at Visit 1;
- Participants who have post-bronchodilator FEV1/FVC ratio of < 0.70 and post-bronchodilator FEV1 of ≥ 25% to < 80% predicted normal at Visit 2;
Key exclusion criteria (28 listed)
- Participants who have a documented history of physician-diagnosed asthma in the opinion of the Investigator based on thorough review of medical history and medical records, within 5 years of Visit 1;
- Participants who have COPD due to α1-Antitrypsin Deficiency;
- Participants with historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neurological, endocrine, gastrointestinal, or pulmonary. Significant is defined as any uncontrolled disease or any disease that, in the opinion of the Investigator, would put the safety of the participant at risk through participation, or that could affect the efficacy or safety analyses;
- Sleep apnea that, in the opinion of the Investigator, cannot be controlled;
- Other respiratory disorders including known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis (high resolution CT evidence of bronchiectasis that causes repeated acute exacerbations), immune deficiency disorders, severe neurological disorders affecting control of the upper airway, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or pulmonary thromboembolic disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BGF MDI HFO 320/14.4/9.6 μgAlso: BGF MDI HFOBudesonide, Glycopyrronium, and Formoterol Fumarate | Drug | BGF MDI HFO 320/14.4/9.6μg |
| BGF MDI HFA 320/14.4/9.6 μgAlso: BGF MDI HFABudesonide, Glycopyrronium, and Formoterol Fumarate | Drug | BGF MDI HFA 320/14.4/9.6 μg |
Primary outcome
Number and Percentage of Participants With Serious Adverse Events
Time frame: Over 12 weeks
To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD
Number and Percentage of Participants With Serious Adverse Events
Time frame: Over 52 weeks
To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD
Number and Percentage of Participants With Non-serious Adverse Events >5%
Time frame: Over 12 weeks
To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD
Number and Percentage of Participants With Non-serious Adverse Events >5%
Time frame: Over 52 weeks
To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD
Number and Percentage of Participants With Adverse Events of Special Interest
Time frame: Over 12 weeks
To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD. Adverse events of special interest in this study are respiratory events such as dysphonia, cough, dyspnea, wheezing, paradoxical bronchospasm, bronchospasm, and COPD exacerbations.
Number and Percentage of Participants With Adverse Events of Special Interest
Time frame: Over 52 weeks
To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD. Adverse events of special interest in this study are respiratory events such as dysphonia, cough, dyspnea, wheezing, paradoxical bronchospasm, bronchospasm, and COPD exacerbations.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40831469Usmani OS, Martinez FJ, Pandya H, Camiolo M, Bednarczyk A, Kucz K, Kokot M, Gottfridsson C, Aurivillius M, Pettersson L, Mei J, Skansen K, Bell JL, Petullo D, Collison K, Bondarov P, Jassal M, Patel M. Safety of budesonide/glycopyrronium/formoterol fumarate dihydrate delivered by HFO-1234ze versus HFA-134a in chronic obstructive pulmonary disease: a phase 3, multi-site, randomised, double-blind, parallel-group, active-comparator study. EClinicalMedicine. 2025 Aug 12;87:103402. doi: 10.1016/j.eclinm.2025.103402. eCollection 2025 Sep.
- CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
91 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BGF MDI HFO 320/14.4/9.6 μg and BGF MDI HFA 320/14.4/9.6 μg in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 91 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 31 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 91 sites in United States, Germany, Poland, Canada, Bulgaria and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and Percentage of Participants With Serious Adverse Events (time frame: Over 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05573464, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.