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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.
Study details:
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 risk of a cardiopulmonary event.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 40 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-02-21
Primary completion: 2028-03-03
Study completion finish: 2028-03-03
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT06283966
Intervention or treatment
DRUG: BGF MDI 320/14.4/9.6 μg
DRUG: GFF MDI 14.4/9.6 μg
Conditions
- • COPD (Chronic Obstructive Pulmonary Disease)
Find a site
Closest Location:
Research Site
Research sites nearby
Select from list below to view details:
Research Site
Chermside, Not Specified, Australia
Research Site
St Albans, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: BGF arm
| DRUG: BGF MDI 320/14.4/9.6 μg
|
EXPERIMENTAL: GFF arm
| DRUG: GFF MDI 14.4/9.6 μg
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Time to first severe cardiac or COPD event | 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. | Up to 3 years |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Time to first severe COPD exacerbation event | 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 COPD exacerbations. | Up to 3 years |
Time to first severe cardiac event | 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 cardiac outcomes. | Up to 3 years |
Time to cardiopulmonary death | 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 deaths. | Up to 3 years |
Moderate/severe COPD exacerbation rate | 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 moderate/severe COPD exacerbations. | Over time, up 3 years |
Time to Myocardial Infarction (MI) hospitalization or cardiac death | 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 the time to MI hospitalization (or cardiac death). | Up to 3 years |
Time to Heart Failure (HF) acute healthcare visit/hospitalization or cardiac death | 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 the time to HF acute healthcare visit/hospitalization (or cardiac death). | Up to 3 years |
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