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

Completed · Phase 3 · Has a placebo group

Conditions studied: COPD (Chronic Obstructive Pulmonary Disease)

In brief

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

Key facts

Study ID

NCT06075095

Run by

AstraZeneca

People needed

297

Starts

2024-01-11

Expected to finish

2025-08-12

Last updated by the study team

2025-08-27

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.
• 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.
• All FOCBP who are sexually active with a non-sterilised male partner must agree to use one highly effective method of birth control, as defined below, from enrolment throughout the study and until at least 14 days after the 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 [15:32] Łubian, Dominika amenorrhoea method are not acceptable methods of contraception. Female condom and male condom should not be used together.
• All FOCBP must have a negative serum pregnancy test result at Visit 1.
• Females < 50 years of age with amenorrhoea for at least 12 months without an alternative medical cause must have a serum FSH test at Visit 1.
• Highly effective birth control methods are listed below:
• Total sexual abstinence is an acceptable method provided it is the preferred and usual lifestyle of the participant (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study interventions).
• Combined (oestrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation:
• o Oral
• o Intravaginal
• o Transdermal

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.
• Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, haematological, neurological, endocrine, gastrointestinal, or pulmonary. Immune deficiency disorders (ie, HIV infection) should be excluded even if controlled. Significant is defined as 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 analysis if the disease/condition is exacerbated during the study.
• Participants with a known hypersensitivity to beta2-agonists, muscarinic antagonists, or corticosteroids, or any component of the MDI.
• Known history of drug or alcohol abuse within 12 months of Visit 1 or known abuse at any time during the study.
• History of QT prolongation associated with another medication that required discontinuation of that medication.
• Prior/Concomitant Therapy
• Unable to abstain from short-acting bronchodilators within 6 hours prior to lung function testing at each study visit.
• Pulmonary resection or lung volume reduction surgery during the 6 months prior to Visit 1 (ie, lobectomy, bronchoscopic lung volume reduction [endobronchial blockers, airway bypass, endobronchial valves, thermal vapour ablation, biological sealants, and airway implants]).
• Long-term-oxygen therapy or nocturnal oxygen therapy required for greater than 15 hours per day.
• Note: As-needed oxygen use is allowed.
• Trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to Visit 1.

Where it is running

• Research Site — Sofia, Bulgaria
• Research Site — Varna, Bulgaria
• Research Site — Veliko Tarnovo, Bulgaria
• Research Site — Vratsa, Bulgaria
• Research Site — Truro, Nova Scotia, Canada
• Research Site — Burlington, Ontario, Canada
• Research Site — Guelph, Ontario, Canada
• Research Site — Québec, Quebec, Canada
• Research Site — Sheffield, Alabama, United States
• Research Site — Clearwater, Florida, United States
• Research Site — Gainesville, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Rincon, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Saint Charles, Missouri, United States
• Research Site — St Louis, Missouri, United States
• Research Site — The Bronx, New York, United States
• Research Site — Raleigh, North Carolina, United States
• Research Site — Dublin, Ohio, United States
• Research Site — Medford, Oregon, United States
• Research Site — Portland, Oregon, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Sofia, Bulgaria

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