Status:
RECRUITING
A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease
Lead Sponsor:
AstraZeneca
Conditions:
COPD (Chronic Obstructive Pulmonary Disease)
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
Brief 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...
Detailed Description
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 ri...
Eligibility Criteria
Inclusion
- Male or female participants must be 40 to 80 years of age inclusive, at the time of signing
- the ICF.
- 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;
- 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.
- A baseline peripheral blood eosinophil count of ≥ 100 cells/mm3 assessed at Visit 1 by
- the central laboratory
- A CAT score of ≥ 10 at Visit 1.
- Participant must fulfill at least 1 of the 4 CV disease/risk factor criteria below \[(a), (b),
- (c), or (d)\]:
- : Established CV Disease
- : Combination of CV risk factors:
- Hypertension
- Diabetes Mellitus
- Chronic Kidney Disease
- Dyslipidemia
- Obesity
- : High risk of CV disease determined using an established CV risk assessment
- tool.
- : CT coronary Artery Calcification
- Willing and, in the opinion of the investigator, able to adjust current COPD therapy, as
- required by the protocol.
- Willing to visit at the study site or participate in virtual visits as required per the protocol
- to complete all study assessments.
- 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.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
Exclusion
- 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.
- End-stage renal disease requiring renal 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 cardiac disease - participants with any of the following at Visit 1 would be excluded:
- An MI or unstable angina in the last 8 weeks
- 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.
- Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 8 weeks prior to Visit 1
- 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.
- Use of maintenance ICS treatment within the past 12 months.
- Unable to abstain from protocol-defined prohibited medications
- 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).
- Participants with a known hypersensitivity to LAMA, LABA or ICS or any component of the MDI.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- 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.
- Previous randomization in the present study.
- For females only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding
Key Trial Info
Start Date :
February 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 7 2028
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT06283966
Start Date
February 21 2024
End Date
March 7 2028
Last Update
March 4 2026
Active Locations (917)
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1
Research Site
Athens, Alabama, United States, 35611
2
Research Site
Cullman, Alabama, United States, 35058
3
Research Site
Fairhope, Alabama, United States, 36532
4
Research Site
Huntsville, Alabama, United States, 35801