Who may be eligible for this COPD clinical trial?

Adults aged 40 to 80 years with a confirmed COPD diagnosis and a history of smoking may be eligible. Participants must have certain heart disease risks and be able to use inhalers correctly. Both men and women can join, but women of childbearing potential need a negative pregnancy test and birth control. Please review eligibility criteria for more details.

Is there any cost to participate in this COPD clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal expenses like travel may vary and are not guaranteed to be covered. Participants should plan for any such costs accordingly.

Actively Recruiting

Phase 3

Age: 40Years - 80Years

All Genders

ID06283966

A Randomized, Double-Blind, Multi-Center Study Comparing Budesonide, Glycopyrronium, and Formoterol Fumarate Inhaler to Glycopyrronium and Formoterol Fumarate Inhaler on Heart and Lung Outcomes in COPD

Q: What is budesonide, glycopyrronium, and formoterol fumarate inhaler studying for COPD?

This clinical trial studies how a triple inhaler containing budesonide, glycopyrronium, and formoterol fumarate impacts heart and lung health in people with COPD. Researchers aim to compare it to a dual inhaler to understand which treatment better manages cardiopulmonary risks. The study is sponsored by AstraZeneca and seeks to improve care for COPD patients at risk of heart problems.

Led by AstraZeneca · Updated on 2026-05-13

5000

Participants Needed

920

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 bcg on heart and lung outcomes in people with chronic obstructive pulmonary disease COPD who have a higher risk of heart and lung problems. This Phase III study compares this triple therapy to a dual therapy inhaler containing glycopyrronium and formoterol fumarate GFF MDI 14.49.6 bcg. The trial is randomized, double-blind, and conducted at multiple centers to assess which treatment better affects cardiopulmonary outcomes.

CONDITIONS

Brief Title

A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease

Who Can Participate

Age: 40Years - 80Years

All Genders

Eligibility Criteria

You may qualify if you...

Male or female participants aged 40 to 80 years at the time of consent
Able to properly use a metered dose inhaler
COPD diagnosis confirmed by post-bronchodilator lung function test showing FEV1/FVC ratio < 70%
Current or former smokers with at least 10 pack-years smoking history
Baseline blood eosinophil count of 100 cells/mm3 or higher
COPD Assessment Test (CAT) score of 10 or more at first visit
Has at least one cardiovascular disease or risk factor such as established heart disease, hypertension, diabetes, chronic kidney disease, dyslipidemia, obesity, or high cardiovascular risk
Willing and able to adjust COPD therapy as required by the protocol
Willing to attend study visits or participate virtually to complete assessments
Women of childbearing potential must have a negative pregnancy test and use effective birth control; non-childbearing women must be post-menopausal or permanently sterilized
Able to provide signed informed consent and comply with study requirements

You will not qualify if you...

Active asthma diagnosis within the past 5 years or asthma-COPD overlap
Other chronic lung diseases besides COPD such as alpha-1 antitrypsin deficiency, tuberculosis, lung fibrosis, sarcoidosis, interstitial lung disease, or pulmonary hypertension
End-stage kidney disease requiring dialysis
History of or awaiting heart or lung transplant
Implanted left ventricular assist device or planned implantation within 3 months
Lung cancer history or treatment within past 5 years
Unstable or life-threatening heart disease such as recent heart attack or unstable arrhythmia within 8 weeks
Recent pneumonia or moderate to severe COPD exacerbation unresolved within 8 weeks
Life-threatening conditions with life expectancy less than 5 years other than COPD or cardiovascular disease
Use of maintenance inhaled corticosteroids within past 12 months
Unable to avoid prohibited medications per protocol
Participation in another clinical trial with investigational treatment within past 30 days or 5 half-lives
Known allergy to study drug components
Involvement in study planning or conduct
Judged unlikely to comply with study procedures
Previously randomized in this study
Pregnant or breastfeeding women

Research Team

AstraZeneca Clinical Study Information Center

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here