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Clinical Trials in the UK / NCT06283966
Recruiting Phase 3

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

NCT06283966 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2024-02-21
Last updated
2026-08-26

Condition(s) studied

COPD (Chronic Obstructive Pulmonary Disease)

Investigational drug(s) / intervention(s)

BGF MDI 320/14.4/9.6 μgGFF MDI 14.4/9.6 μg

BGF MDI 320/14.4/9.6 μg: Budesonide, glycopyrronium, and formoterol fumarate pressurized inhalation suspension

GFF MDI 14.4/9.6 μg: Glycopyrronium and formoterol fumarate pressurized inhalation suspension

Study summary

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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (921)

FacilityCityRegionStatus
Research Site Athens Alabama Terminated
Research Site Cullman Alabama Recruiting
Research Site Fairhope Alabama Terminated
Research Site Huntsville Alabama Terminated
Research Site Mobile Alabama Recruiting
Research Site Sheffield Alabama Withdrawn
Research Site Gilbert Arizona Recruiting
Research Site Glendale Arizona Withdrawn
Research Site Mesa Arizona Recruiting
Research Site Mesa Arizona Recruiting
Research Site Phoenix Arizona Terminated
Research Site Tempe Arizona Suspended
Research Site Tempe Arizona Terminated
Research Site Tucson Arizona Recruiting
Research Site Tucson Arizona Recruiting
Research Site Apple Valley California Withdrawn
Research Site Canoga Park California Suspended
Research Site Castroville California Recruiting
Research Site Garden Grove California Recruiting
Research Site Gardena California Terminated
Research Site Inglewood California Recruiting
Research Site La Mesa California Recruiting
Research Site La Palma California Recruiting
Research Site Lomita California Recruiting
Research Site Long Beach California Recruiting
Research Site Los Alamitos California Terminated
Research Site Mission Viejo California Recruiting
Research Site Newport Beach California Recruiting
Research Site North Hollywood California Terminated
Research Site Pomona California Recruiting
Research Site Sacramento California Recruiting
Research Site Sacramento California Recruiting
Research Site San Bernardino California Terminated
Research Site San Diego California Terminated
Research Site San Dimas California Withdrawn
Research Site Santa Ana California Withdrawn
Research Site Tarzana California Recruiting
Research Site Thousand Oaks California Recruiting
Research Site Van Nuys California Withdrawn
Research Site Vista California Recruiting

+ 881 more sites — see the full list on the official registry below.

More AstraZeneca trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06283966 on ClinicalTrials.gov ↗ ← All trials in the UK