A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease
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)
Time to first severe cardiac or COPD event — Up to 3 years Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on cardiopulmonary outcomes.
Trial sites (921)
Facility
City
Region
Status
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.
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.