BridgeMD
A Study Evaluating the Efficacy of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered-Dose Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease
EU CTIS ID: 2023-507407-59-00
What this study is testing
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 severe cardiopulmonary outcomes.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1 Male or female participants must be 40 to 80 years of age inclusive, at the time of signing the ICF.
- 9 Willing to visit at the study site or participate in virtual visits as required per the protocol to complete all study assessments.
- 2 Demonstrate acceptable MDI administration technique at Visit 1(V1) and Visit 2(V2) (randomization)
- 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.
- 3 A diagnosis of COPD confirmed by a post-bronchodilator FEV1/FVC ratio < 70% predicted at V1.
You likely can't join if
- 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.
- 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 this 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.
See the full eligibility criteria
Who can join
- 1 Male or female participants must be 40 to 80 years of age inclusive, at the time of signing the ICF.
- 9 Willing to visit at the study site or participate in virtual visits as required per the protocol to complete all study assessments.
- 2 Demonstrate acceptable MDI administration technique at Visit 1(V1) and Visit 2(V2) (randomization)
- 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.
- 3 A diagnosis of COPD confirmed by a post-bronchodilator FEV1/FVC ratio < 70% predicted 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)]. (a) Established CV (b) Combination of CV risk factors: • Hypertension • diabetes mellitus • chronic kidney disease• dyslipidemia • obesity (c) High risk of CV disease determined using an established CV risk assessment tool (d) CT coronary artery calcification
- 8 Willing and, in the opinion of the investigator, able to adjust current COPD therapy, as required by the protocol.
What rules you out
- 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.
- 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 this 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.
- 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: (a) An MI or unstable angina in the last 8 weeks (b) 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 (see Section 5.4 regarding rescreening or extension of run-in period).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chile
- Canada
- Philippines
- United States
- Australia
- Mexico
- Taiwan
- Serbia
- Turkey
- China
- Korea, Republic of
- Peru
- Ukraine
- Thailand
- Colombia
- United Kingdom
- India
- Malaysia
- Brazil
- Argentina
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chile; Canada; Philippines; United States; Australia; Mexico and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.