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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (26 UK sites)
Research Site
Bicester OX26 6AT, United Kingdom
Research Site
Bollington SK10 5JH, United Kingdom
Research Site
Bradford BD13 2GD, United Kingdom
Research Site
Cardiff CF37 2DR, United Kingdom
Research Site
Chesterfield S40 4AA, United Kingdom
Research Site
Corby NN17 2UR, United Kingdom
Research Site
Cottingham HU16 5JQ, United Kingdom
Research Site
Fowey PL23 1DT, United Kingdom
Research Site
Glasgow G4 0SF, United Kingdom
Research Site
Hounslow TW4 7NR, United Kingdom
Research Site
Liverpool L14 3PE, United Kingdom
Research Site
London EC1M 6BQ, United Kingdom
Research Site
London NW3 2QG, United Kingdom
Research Site
London SW1P 2PF, United Kingdom
Research Site
Manchester M8 5RB, United Kingdom
Research Site
Newquay TR7 1RU, United Kingdom
Research Site
North Somerset BS23 3HQ, United Kingdom
Research Site
Northallerton DL7 8AW, United Kingdom
Research Site
Norwich NR1 1RB, United Kingdom
Research Site
Nottingham NG9 6DX, United Kingdom
Research Site
Perth PH1 1NX, United Kingdom
Research Site
Poole BH16 5PW, United Kingdom
Research Site
Sheffield S9 5DH, United Kingdom
Research Site
Torbay TQ1 4QX, United Kingdom
Research Site
Whitney OX29 4QB, United Kingdom
Research Site
Witney OX28 6JS, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
