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

NCT05573464 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: D5985C000032022-001476-33
• Study Type: interventional
• Target: 559
• Locations: 9 countries
• Sites: 91

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (6)

• 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

  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

  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

  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

  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.

  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.

  Over 52 weeks

Study Arms (2)

BGF MDI HFO 320/14.4/9.6μg

EXPERIMENTAL

Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO (HFO-1234ze)

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

Drug: BGF MDI HFA 320/14.4/9.6 μg

Interventions

BGF MDI HFO 320/14.4/9.6 μg DRUG

Budesonide, Glycopyrronium, and Formoterol Fumarate

Also known as: BGF MDI HFO

BGF MDI HFO 320/14.4/9.6μg

BGF MDI HFA 320/14.4/9.6 μg DRUG

Budesonide, Glycopyrronium, and Formoterol Fumarate

Also known as: BGF MDI HFA

BGF MDI HFA 320/14.4/9.6 μg

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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
• 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;

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (91)

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Phoenix, Arizona, 85032, United States

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Newport Beach, California, 92663, United States

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Miami, Florida, 33175, United States

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Sarasota, Florida, 34239, United States

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Tampa, Florida, 33606, United States

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Valparaiso, Indiana, 46383, United States

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Crowley, Louisiana, 70526, United States

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North Dartmouth, Massachusetts, 02747, United States

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St Louis, Missouri, 63141, United States

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Charlotte, North Carolina, 28209, United States

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Wilmington, North Carolina, 28401, United States

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Dublin, Ohio, 43016, United States

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Grants Pass, Oregon, 97527, United States

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Portland, Oregon, 97202, United States

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Anderson, South Carolina, 29621, United States

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Columbia, South Carolina, 29204, United States

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Gaffney, South Carolina, 29340, United States

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Longview, Texas, 75605, United States

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McKinney, Texas, 75069, United States

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Richmond, Virginia, 23219, 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, S2000DEJ, Argentina

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San Fernando, B1646EBJ, Argentina

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Blagoevgrad, 2700, Bulgaria

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Dupnitsa, 2602, Bulgaria

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Lom, 3600, Bulgaria

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Pernik, 2300, Bulgaria

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Sandanski, 2800, Bulgaria

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Sevlievo, 5400, Bulgaria

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Sofia, 1618, Bulgaria

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Veliko Tarnovo, 5000, Bulgaria

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Vidin, 3700, Bulgaria

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Truro, Nova Scotia, B2N 1L2, Canada

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Ajax, Ontario, L1S 2J5, Canada

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Burlington, Ontario, L7N 3V2, Canada

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Guelph, Ontario, N1H 6J2, Canada

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Montreal, Quebec, H1Y 3H5, Canada

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Québec, Quebec, G1G 3Y8, Canada

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Québec, Quebec, G1V 4G5, Canada

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Québec, Quebec, G2J 0C4, Canada

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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada

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Trois-Rivières, Quebec, G8T 7A1, Canada

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Berlin, 10629, Germany

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Berlin, 10787, Germany

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Berlin, 10969, Germany

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Berlin, 12159, Germany

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Berlin, 13156, Germany

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Dresden, 01069, Germany

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Elsterwerda, 04910, Germany

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Essen, 45359, Germany

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Halle, 06108, Germany

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Hamburg, 20253, Germany

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Hanover, 30159, Germany

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Hanover, 30449, Germany

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Hanover, D-30173, Germany

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Karlsruhe, 76137, Germany

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Koblenz, 56068, Germany

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Magdeburg, 39120, Germany

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Rheine, 48431, Germany

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Schwerin, 19055, Germany

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Wiesbaden, 65189, Germany

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Witten, 58452, Germany

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Cuernavaca, 62290, Mexico

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Culiacán, 80200, Mexico

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Mérida, 97130, Mexico

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México, 03300, Mexico

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Monterrey, 64020, Mexico

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Będzin, 42-500, Poland

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Bydgoszcz, 85-231, Poland

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Grodzisk Mazowiecki, 05-825, Poland

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Inowrocław, 88-100, Poland

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Jelenia Góra, 58-506, Poland

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Krakow, 31-011, Poland

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Lodz, 91-053, Poland

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Lublin, 20-412, Poland

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Piaseczno, 05-500, Poland

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Skórzewo, 60-185, Poland

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Szczecin, 70-111, Poland

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Zamość, 22-400, Poland

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Ankara, 06620, Turkey (Türkiye)

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Istanbul, 34020, Turkey (Türkiye)

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Izmir, 35110, Turkey (Türkiye)

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Mersin, 33343, Turkey (Türkiye)

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Pamukkale, 20070, Turkey (Türkiye)

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Blackpool, FY3 7EN, United Kingdom

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Corby, NN17 2UR, United Kingdom

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Liverpool, L1 9ED, United Kingdom

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Poole, BH15 2HX, United Kingdom

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Thetford, IP24 1JD, United Kingdom

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Related Publications (1)

• 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.

  PMID: 40831469 DERIVED

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca

information.center@astrazeneca.com

1-877-240-9479

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: October 10, 2022
• Study Start: September 27, 2022
• Primary Completion: March 26, 2024
• Study Completion: March 26, 2024
• Last Updated: September 19, 2025
• Results First Posted: September 19, 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.

Locations

GB (5); ME (5); CA (10); DE (20); BU (9); TU (5); AR (5); PL (12); US (20)