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Looking for participantsPhase3

A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease

Sponsor: AstraZeneca

NCT ID: NCT06283966

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
BGF MDI 320/14.4/9.6 μg (drug), GFF MDI 14.4/9.6 μg (drug)
How long the study runs
Study runs about 46 months (dates as stated)
About the drug or intervention
BGF MDI 320/14.4/9.6 μg — drug: Budesonide, glycopyrronium, and formoterol fumarate pressurized inhalation suspension · GFF MDI 14.4/9.6 μg — drug: Glycopyrronium and formoterol fumarate pressurized inhalation suspension
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
40 Years to 80 Years
Who
All
Number of participants
5,250
Started
2024-02-21
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for copd (chronic obstructive pulmonary disease)
  • • Phase3 - 5,250 participants
  • • This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14

Who can take part?

  • • Ages 40 Years to 80 Years
  • • Diagnosed with copd (chronic obstructive pulmonary disease)

Where?

  • • Bicester - Research Site
  • • Bollington - Research Site
  • • Bradford - Research Site
  • • Cardiff - Research Site
  • • +22 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk.

More detail

This is a Phase III randomized, double-blind, parallel group, multi-center event-driven study comparing BGF MDI 320/14.4/9.6 μg BID with GFF MDI 14.4/9.6 μg BID in participants with COPD who are at risk of a cardiopulmonary event.

COPD (Chronic Obstructive Pulmonary Disease)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 40 Years - 80 Years
  • Who can join: All genders

Biomarkers mentioned

has a negativewith positive

Treatment history

Treatments you must have had:

  • ✓ by the protocol
  • ✓ per the protocol

What the study is looking for

  • ✓Male or female participants must be 40 to 80 years of age inclusive, at the time of signing
  • ✓Demonstrate acceptable MDI administration technique at Visit 1 (V1) and Visit 2 (V2)
  • ✓A diagnosis of COPD confirmed by a post-bronchodilator FEV1/FVC ratio \< 70%
  • ✓at V1.
  • ✓Current or former smokers with a history of at least 10 pack-years of cigarette smoking;

Who cannot take part

  • ✗End-stage kidney disease requiring kidney replacement therapy
  • ✗History of heart or lung transplant or actively listed for heart or lung transplant.
  • ✗Implanted left ventricular assist device or implant anticipated in \< 3 months.
  • ✗History of lung cancer and/or treatment for lung cancer within the 5 years prior to Visit 1.
  • ✗Unstable or life-threatening heart disease - participants with any of the following at Visit 1 would be excluded:
See the full criteria
Inclusion Criteria: 1. Male or female participants must be 40 to 80 years of age inclusive, at the time of signing the ICF. 2. Demonstrate acceptable MDI administration technique at Visit 1 (V1) and Visit 2 (V2) 3. A diagnosis of COPD confirmed by a post-bronchodilator FEV1/FVC ratio \< 70% at V1. 4. Current or former smokers with a history of at least 10 pack-years of cigarette smoking; defined as (number of cigarettes per day/20) x number of years smoked. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to V1. 5. A baseline peripheral blood eosinophil count of ≥ 100 cells/mm3 assessed at Visit 1 by the central laboratory 6. A CAT score of ≥ 10 at Visit 1. 7. Participant must fulfill at least 1 of the 4 CV disease/risk factor criteria below \[(a), (b), (c), or (d)\]: 1. : Established CV Disease 2. : Combination of CV risk factors: * Hypertension * Diabetes Mellitus * Chronic Kidney Disease * Dyslipidemia * Obesity 3. : High risk of CV disease determined using an established CV risk assessment tool. 4. : CT coronary Artery Calcification 8. Willing and, in the opinion of the investigator, able to adjust current COPD therapy, as required by the protocol. 9. Willing to visit at the study site or participate in virtual visits as required per the protocol to complete all study assessments. 10. A female is eligible to enter and participate in the study if the female is of: * Non-childbearing potential: either permanently sterilized or who are post-menopausal. * Childbearing potential: has a negative serum pregnancy test at V1 and must use one highly effective form of birth control. 11. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol. Exclusion Criteria: 1. Active diagnosis of asthma within the past 5 years (previous diagnosis as a child or adolescent are eligible), asthma-COPD overlap, or any other chronic respiratory disease other than COPD such as alpha-1 antitrypsin deficiency, active tuberculosis, lung fibrosis, sarcoidosis, interstitial lung disease, and pulmonary hypertension. 2. End-stage renal disease requiring renal replacement therapy 3. History of heart or lung transplant or actively listed for heart or lung transplant. 4. Implanted left ventricular assist device or implant anticipated in \< 3 months. 5. History of lung cancer and/or treatment for lung cancer within the 5 years prior to Visit 1. 6. Unstable or life-threatening cardiac disease - participants with any of the following at Visit 1 would be excluded: 1. An MI or unstable angina in the last 8 weeks 2. Unstable or life-threatening cardiac arrhythmia requiring intervention in the last 8 weeks. NOTE: Any participant who experiences unstable or life-threatening cardiac disease during the run-in period will be excluded but can be rescreened 8 weeks after the resolution of the event. 7. Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 8 weeks prior to Visit 1 8. Any life-threatening condition, including malignancy, with a life expectancy \< 5 years, other than CV disease or COPD, that might prevent the participant from completing the study. 9. Use of maintenance ICS treatment within the past 12 months. 10. Unable to abstain from protocol-defined prohibited medications 11. Participation in another clinical study with a study intervention administered in the last 30 days or 5 half-lives, whichever is longer prior to Visit 1 (any other investigational product that is not identified in protocol is prohibited for use during the duration of the study). 12. Participants with a known hypersensitivity to LAMA, LABA or ICS or any component of the MDI. 13. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). 14. Judgment 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. 15. Previous randomization in the present study. 16. For females only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding

Where Is This Study? (26 UK sites)

Research Site

Bicester OX26 6AT, United Kingdom

Recruiting

Research Site

Bollington SK10 5JH, United Kingdom

Recruiting

Research Site

Bradford BD13 2GD, United Kingdom

ACTIVE_NOT_RECRUITING

Research Site

Cardiff CF37 2DR, United Kingdom

Recruiting

Research Site

Chesterfield S40 4AA, United Kingdom

Recruiting

Research Site

Corby NN17 2UR, United Kingdom

ACTIVE_NOT_RECRUITING

Research Site

Cottingham HU16 5JQ, United Kingdom

WITHDRAWN

Research Site

Fowey PL23 1DT, United Kingdom

Recruiting

Research Site

Glasgow G4 0SF, United Kingdom

ACTIVE_NOT_RECRUITING

Research Site

Hounslow TW4 7NR, United Kingdom

Recruiting

Research Site

Liverpool L14 3PE, United Kingdom

Recruiting

Research Site

London EC1M 6BQ, United Kingdom

COMPLETED

Research Site

London NW3 2QG, United Kingdom

ACTIVE_NOT_RECRUITING

Research Site

London SW1P 2PF, United Kingdom

Recruiting

Research Site

Manchester M8 5RB, United Kingdom

Recruiting

Research Site

Newquay TR7 1RU, United Kingdom

ACTIVE_NOT_RECRUITING

Research Site

North Somerset BS23 3HQ, United Kingdom

Recruiting

Research Site

Northallerton DL7 8AW, United Kingdom

Recruiting

Research Site

Norwich NR1 1RB, United Kingdom

WITHDRAWN

Research Site

Nottingham NG9 6DX, United Kingdom

WITHDRAWN

Research Site

Perth PH1 1NX, United Kingdom

WITHDRAWN

Research Site

Poole BH16 5PW, United Kingdom

Recruiting

Research Site

Sheffield S9 5DH, United Kingdom

ACTIVE_NOT_RECRUITING

Research Site

Torbay TQ1 4QX, United Kingdom

Recruiting

Research Site

Whitney OX29 4QB, United Kingdom

Recruiting

Research Site

Witney OX28 6JS, United Kingdom

ACTIVE_NOT_RECRUITING

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09