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Tests treatment safety and results for COPD (Chronic Obstructive Pulmonary Disease)
Official title A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease
ClinicalTrials.gov ID: NCT06283966
What this study is testing
What is BGF MDI 320/14.4/9.6 μg?
BGF MDI 320/14.4/9.6 μg is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for copd (chronic obstructive pulmonary disease).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- 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...
- A baseline peripheral blood eosinophil count of ≥ 100 cells/mm3 assessed at Visit 1 by the central laboratory
You likely can't join if
- Active diagnosis of asthma within the past 5 years (previous diagnosis as a child or adolescent are eligible), asthma-COPD overlap, or any other...
- 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:
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Athens, Alabama, United States
- Cullman, Alabama, United States
- Fairhope, Alabama, United States
- Huntsville, Alabama, United States
- Mobile, Alabama, United States
- Sheffield, Alabama, United States
- Gilbert, Arizona, United States
- Glendale, Arizona, United States
- Mesa, Arizona, United States
- Phoenix, Arizona, United States
- Tempe, Arizona, United States
- Tucson, Arizona, United States
- Apple Valley, California, United States
- Canoga Park, California, United States
- Castroville, California, United States
- Garden Grove, California, United States
- Gardena, California, United States
- Inglewood, California, United States
- La Mesa, California, United States
- La Palma, California, United States
+ 681 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, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Athens, Alabama, United States; Cullman, Alabama, United States; Fairhope, Alabama, United States; Huntsville, Alabama, United States; Mobile, Alabama, United States; Sheffield, Alabama, United States and 695 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 ClinicalTrials.gov; the study team decides eligibility.