Comparing BGF MDI 320/14.4/9.6 μg with GFF MDI 14.4/9.6 μg 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
A Randomized, Double-blind, Parallel Group, Multi-center, Phase III Study to Assess the Efficacy of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler Relative to Glycopyrronium and Formoterol Fumarate MDI on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease (THARROS)
- Phase 3
- 2 groups
- Sites in Calgary, Sherwood Park and 15 more cities
- Recruiting
Interventions
- Medication
BGF MDI 320/14.4/9.6 μg
Budesonide, glycopyrronium, and formoterol fumarate pressurized inhalation suspension
- Medication
GFF MDI 14.4/9.6 μg
Glycopyrronium and formoterol fumarate pressurized inhalation suspension
Canadian Sites (22)
19 of 22 recruiting
- Recruiting
Research Site
Calgary, Alberta
- Recruiting
Research Site
Sherwood Park, Alberta
- Recruiting
Research Site
Kelowna, British Columbia
- Recruiting
Research Site
Richmond, British Columbia
- Recruiting
Research Site
Winnipeg, Manitoba
- Recruiting
Research Site
Sydney, Nova Scotia
- Recruiting
Research Site
Ajax, Ontario
- Recruiting
Research Site
Guelph, Ontario
- Recruiting
Research Site
Hamilton, Ontario
- Recruiting
Research Site
Kingston, Ontario
- Recruiting
Research Site
Kingston, Ontario
- Recruiting
Research Site
Thunder Bay, Ontario
- Recruiting
Research Site
Montreal, Quebec
- Recruiting
Research Site
Québec, Quebec
- Recruiting
Research Site
Québec, Quebec
- Recruiting
Research Site
Québec, Quebec
- Recruiting
Research Site
Saint-Charles-Borromée, Quebec
- Recruiting
Research Site
Trois-Rivières, Quebec
- Recruiting
Research Site
Trois-Rivières, Quebec
- Withdrawn
Research Site
Toronto, Ontario
- Completed
Research Site
Québec, Quebec
- Withdrawn
Research Site
Saskatoon, Saskatchewan
Eligibility Criteria
See who this study is looking for47 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Male or female participants must be 40 to 80 years of age inclusive, at the time of signing
- +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%
- +months prior to V1.
- +A baselineBaselineYour starting measurements, taken before treatment begins.Read more → 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
- +: High risk of CV disease determined using an established CV risk assessment
- +: CT coronary Artery Calcification
- +Willing and, in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, able to adjust current COPD therapy, as
- +required by the protocolProtocolThe detailed plan a study must follow.Read more →.
- +Willing to visit at the study siteTrial siteA hospital or clinic where a study is actually run.Read more → 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:
- +highly effective form of birth controlControl groupThe group a new treatment is measured against.Read more →.
- +Capable of giving signed informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
- +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
- +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
Exclusion
- −Participants with a known hypersensitivity to LAMA, LABA or ICS or any component of the MDI.
- −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 periodRun-in periodA short trial period before the study proper begins.Read more → 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 protocolProtocolThe detailed plan a study must follow.Read more →-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).
- −Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study siteTrial siteA hospital or clinic where a study is actually run.Read more →).
- −Judgment by the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
- −Previous randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → in the present study.
- −For females only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives BGF MDI 320/14.4/9.6 μg.
Registry label: A: BGF arm
Group B receives GFF MDI 14.4/9.6 μg.
Registry label: B: GFF arm
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 40 years to 80 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 5,000 people.
The study is currently expected to finish around December 2027.
The main measurement is taken over: Up to 3 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Time to first severe cardiac or COPD event — measured over Up to 3 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06283966 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About BGF MDI 320/14.4/9.6 μgDrug
Budesonide, glycopyrronium, and formoterol fumarate pressurized inhalation suspension
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About GFF MDI 14.4/9.6 μgDrug
Glycopyrronium and formoterol fumarate pressurized inhalation suspension
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 40 years to 80 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 40 years to 80 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 3 years.
The study as a whole is currently expected to finish around 2027-12-03.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 5,000 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 30 locations, including: Calgary, Alberta, Canada; Sherwood Park, Alberta, Canada; Kelowna, British Columbia, Canada; Richmond, British Columbia, Canada; Winnipeg, Manitoba, Canada; Sydney, Nova Scotia, Canada, and 24 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (16)
Research Site
Ann Arbor, Michigan, United States
Research Site
Flint, Michigan, United States
Research Site
Southfield, Michigan, United States
Research Site
Southfield, Michigan, United States
Research Site
Missoula, Montana, United States
Research Site
Albany, New York, United States
Research Site
Albany, New York, United States
Research Site
Bronxville, New York, United States
Research Site
Brooklyn, New York, United States
Research Site
Massapequa, New York, United States
Research Site
New Windsor, New York, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Research Site
The Bronx, New York, United States
Research Site
Vestal, New York, United States
Research Site
Spokane, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.