AzTrials
AzTrials

COPD (Chronic Obstructive Pulmonary Disease)Phase 3NCT06075095

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 Phase 3 study testing BGF MDI HFO 320/14.4/9.6μg and BGF MDI HFA 320/14.4/9.6 μg in people with COPD (Chronic Obstructive Pulmonary Disease), run by AstraZeneca at 87 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years
What is being tested?
BGF MDI HFO 320/14.4/9.6μg and BGF MDI HFA 320/14.4/9.6 μg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
297 participants
Where
87 sitesin 14 countries
Study dates
11 Jan 2024to 12 Aug 2025
Phase
Phase 3
Are there results?
None posted in the registry

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

  • 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.
Show all 35Show fewer
  • 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
  • <!-- -->
  • 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
  • Progestogen-only hormonal contraception associated with inhibition of ovulation: o Oral
  • o Injectable
  • Implantable
  • Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
  • Bilateral tubal occlusion
  • Male partner sterilisation/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. Informed Consent 11 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.
  • Other Inclusion Criteria 12 Participants with calculated eGFR > 30 mL/min/1.73 m2 using the CKD-EPI formula.
  • 13 Participants who demonstrate acceptable MDI administration and spirometry techniques.
  • 14 Participants who remain compliant with placebo run-in administrations, defined as ≥ 80% of planned doses over the last 7 days prior to Visit 3, based on ePRO diary data.
  • 15 Participants who are willing to remain at the study centre as required per protocol to complete all visit assessments.

Who cannot join

  • 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.
Show all 40Show fewer
  • 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.
  • Unable to abstain from any protocol-defined prohibited medications during the Screening or Treatment Periods (see Section 6.9).
  • Use of any herbal products by either inhalation or nebuliser within 2 weeks prior to Visit 1 or refusal to stop use for the duration of the study.
  • Prior/Concurrent Clinical Study Experience
  • Participation in another clinical study with a study intervention administered within 30 days or 5 half-lives, whichever is longer, prior to Visit 1.
  • Diagnostic Assessments
  • Participants with ECG QTcF interval > 480 milliseconds.
  • Participants with high-degree atrioventricular block II or III, or with sinus node dysfunction with clinically significant pauses who are not treated with pacemaker.
  • Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs, or ECG which, in the opinion of the Investigator, may put the participant at risk because of their participation in the study.
  • Other Exclusions
  • Planned hospitalisation during the study.
  • Involvement in the planning or conduct of the study (applies to both AstraZeneca staff and staff at the study sites).
  • Study Investigators, sub-Investigators, coordinators, and their employees or immediate family members.
  • Judgement by the Investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
  • Previous randomisation in the present study.
  • For women only: currently pregnant (confirmed with positive pregnancy test), breastfeeding, or planned pregnancy during the study, or FOCBP not using acceptable contraception measures.

Trial locations and contacts

87 sites in 14 countries.

87 sites in 14 countries

United States19 sites

  • Research Site

    Boerne, Texas, 78006

  • Research Site

    Chicago, Illinois, 60607

  • Research Site

    Clearwater, Florida, 33765

  • Research Site

    Dublin, Ohio, 43016

  • Research Site

    El Paso, Texas, 79912

  • Research Site

    Gaffney, South Carolina, 29340

  • Research Site

    Gainesville, Florida, 32605

  • Research Site

    Medford, Oregon, 97504

  • Research Site

    Miami, Florida, 33175

  • Research Site

    Orlando, Florida, 32825

  • Research Site

    Philadelphia, Pennsylvania, 19114

  • Research Site

    Portland, Oregon, 97202

  • Research Site

    Raleigh, North Carolina, 27607

  • Research Site

    Rincon, Georgia, 31326

  • Research Site

    Saint Charles, Missouri, 63301

  • Research Site

    Sheffield, Alabama, 35660

  • Research Site

    St Louis, Missouri, 63141

  • Research Site

    Tampa, Florida, 33606

  • Research Site

    The Bronx, New York, 10455

Other trials in United States

Bulgaria9 sites

  • Research Site

    Burgas, 8000

  • Research Site

    Pernik, 2300

  • Research Site

    Pleven, 5800

  • Research Site

    Plovdiv, 4002

  • Research Site

    Sofia, 1202

  • Research Site

    Sofia, 1756

  • Research Site

    Varna, 9000

  • Research Site

    Veliko Tarnovo, 5000

  • Research Site

    Vratsa, 3000

Other trials in Bulgaria

Turkey (Türkiye)7 sites

  • Research Site

    Ankara, 06620

  • Research Site

    Dinar, 03400

  • Research Site

    Istanbul, 34020

  • Research Site

    Istanbul, 34722

  • Research Site

    Izmir, 35110

  • Research Site

    Izmir, 35965

  • Research Site

    Kayseri, 38030

Other trials in Turkey (Türkiye)

Vietnam7 sites

  • Research Site

    Can Tho, 900000

  • Research Site

    Da Nang, 550000

  • Research Site

    Hà Nội, 100000

  • Research Site

    Haiphong, 180000

  • Research Site

    Hanoi, 10000

  • Research Site

    Ho Chi Minh City, 700000

  • Research Site

    Hochiminh, 70000

Other trials in Vietnam

India6 sites

  • Research Site

    Ajmer, 305001

  • Research Site

    Aligarh, 202002

  • Research Site

    Coimbatore, 641028

  • Research Site

    Jaipur, 302039

  • Research Site

    Kanpur, 208002

  • Research Site

    Surat, 395009

Other trials in India

Argentina5 sites

  • Research Site

    Buenos Aires, C1414AIF

  • Research Site

    Buenos Aires, C1425BEN

  • Research Site

    Quilmes, B1878FNR

  • Research Site

    Rosario, 2000

  • Research Site

    San Fernando, B1646EBJ

Other trials in Argentina

Canada5 sites

  • Research Site

    Burlington, Ontario, L7N 3V2

  • Research Site

    Guelph, Ontario, N1H 6J2

  • Research Site

    Québec, Quebec, G1W 4R4

  • Research Site

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • Research Site

    Truro, Nova Scotia, B2N 1L2

Other trials in Canada

Hungary5 sites

  • Research Site

    Balassagyarmat, 2660

  • Research Site

    Hajdúnánás, 4080

  • Research Site

    Mosonmagyaróvár, 9200

  • Research Site

    Pécs, 7635

  • Research Site

    Püspökladány, 4150

Other trials in Hungary

Mexico5 sites

  • Research Site

    Benito Juárez, 03650

  • Research Site

    Chihuahua City, 31200

  • Research Site

    Cuernavaca, 62290

  • Research Site

    Monterrey, 64465

  • Research Site

    Zapopan, 45138

Other trials in Mexico

South Korea5 sites

  • Research Site

    Daegu, 42415

  • Research Site

    Jeonju, 54907

  • Research Site

    Seoul, 04763

  • Research Site

    Seoul, 06591

  • Research Site

    Ulsan, 44033

Other trials in South Korea

Malaysia4 sites

  • Research Site

    George Town, 10450

  • Research Site

    Ipoh, 30990

  • Research Site

    Kuala Lumpur, 50586

  • Research Site

    Kuala Terengganu, 20400

Other trials in Malaysia

Thailand4 sites

  • Research Site

    Chiang Mai, 50200

  • Research Site

    Hat Yai, 90110

  • Research Site

    Khon Kaen, 40002

  • Research Site

    Muang, 22000

Other trials in Thailand

Philippines3 sites

  • Research Site

    Iloilo City, 5000

  • Research Site

    Las Piñas, 1742

  • Research Site

    Quezon City, 1000

Other trials in Philippines

Poland3 sites

  • Research Site

    Bialystok, 15-044

  • Research Site

    Chęciny, 26-060

  • Research Site

    Lublin, 20-601

Other trials in Poland

About this study

Official title: 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

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
Read the detailed description

This is a phase III, randomised, placebo-controlled, double-blind, multi-centre, 4-week, 3-way crossover pharmacodynamic study to assess the equivalence of BGF MDI HFO compared with BGF MDI HFA in participants with COPD. To demonstrate assay sensitivity, BGF MDI HFA will be compared to placebo MDI HFA for superiority in lung function, both pre- and post-dose.

Eligible participants are between 40 and 80 years of age, inclusive, who have an established clinical history of COPD as defined by the ATS/ERS. Participants are required to have an FEV1/FVC ratio of < 0.70, have a post-bronchodilator FEV1 ≥ 40% and < 80% predicted normal value, have a blood eosinophil count < 300 cells/μL, and be current or former cigarette smokers with a history of at least 10 pack-years. Participants must not have had a COPD exacerbation treated with oral corticosteroids or antibiotics within 4 months prior to initiation of screening, and must not have had a COPD exacerbation that required hospitalisation within 12 months prior to initiation of screening. Eligible participants are those on treatment with LABA, LAMA, LAMA/LABA (open or fixed-dose combination), ICS/LABA (open or fixed-dose combination) inhaled maintenance therapies, or SABA, SAMA, or SAMA/SABA scheduled or as-needed inhaled therapies, or who are naïve to COPD therapy.

This study will be conducted at approximately 95 sites globally. After screening, participants will be randomised 1:1:1:1:1:1 to receive study interventions in one of 6 possible treatment sequences.

Being tested
BGF MDI HFO 320/14.4/9.6μg, BGF MDI HFA 320/14.4/9.6 μg, Placebo MDI HFA
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 320/14.4/9.6μgDrug

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

    Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart)

  • BGF MDI HFA 320/14.4/9.6 μgDrug

    Also called Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF), Delivered by MDI HFA

    Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart):

  • Placebo MDI HFADrug

    Also called Placebo

    Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart)

Study groups in NCT06075095
Study groupRoleWhat they receive
Treatment Sequence 1ExperimentalEach 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
Receives: Drug: BGF MDI HFO 320/14.4/9.6μg; Drug: BGF MDI HFA 320/14.4/9.6 μg; Drug: Placebo MDI HFA
Treatment Sequence 2ExperimentalEach 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
Receives: Drug: BGF MDI HFO 320/14.4/9.6μg; Drug: BGF MDI HFA 320/14.4/9.6 μg; Drug: Placebo MDI HFA
Treatment Sequence 3ExperimentalEach 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
Receives: Drug: BGF MDI HFO 320/14.4/9.6μg; Drug: BGF MDI HFA 320/14.4/9.6 μg; Drug: Placebo MDI HFA
Treatment Sequence 4ExperimentalEach 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
Receives: Drug: BGF MDI HFO 320/14.4/9.6μg; Drug: BGF MDI HFA 320/14.4/9.6 μg; Drug: Placebo MDI HFA
Treatment Sequence 5ExperimentalEach 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
Receives: Drug: BGF MDI HFO 320/14.4/9.6μg; Drug: BGF MDI HFA 320/14.4/9.6 μg; Drug: Placebo MDI HFA
Treatment Sequence 6ExperimentalEach 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
Receives: Drug: BGF MDI HFO 320/14.4/9.6μg; Drug: BGF MDI HFA 320/14.4/9.6 μg; Drug: Placebo MDI HFA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Change from baseline at Day 29

  2. 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

    Measured: Change from baseline at Day 29

  3. 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

    Measured: Change from baseline at Day 29

  4. 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

    Measured: Change from baseline at Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2023
  2. Study start11 Jan 2024
  3. Primary completion12 Aug 2025
  4. Study completion12 Aug 2025

Resources

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
Crossover
Model description
This is a phase III, randomised, placebo-controlled, double-blind, multi-centre, 4-week, 3-way crossover pharmacodynamic study to assess the equivalence of BGF MDI HFO compared with BGF MDI HFA in participants with COPD.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
297 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06075095
Sponsor's protocol ID
D5985C00002
Other IDs
2023-506565-57-00, 2023
Status last verified
Aug 2025
First submitted
4 Oct 2023
Last updated
27 Aug 2025
Results posted
No
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BGF MDI HFO 320/14.4/9.6μg and BGF MDI HFA 320/14.4/9.6 μg in people with COPD (Chronic Obstructive Pulmonary Disease), run by AstraZeneca at 87 sites in 14 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 35 inclusion and 40 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 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in United States, Bulgaria, Turkey (Türkiye), Vietnam, India and 9 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Changes in FEV1 AUC (0-4) (time frame: Change from baseline at Day 29). The study lists 4 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 NCT06075095.

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 27 Aug 2025.

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