Who is eligible for clinical trial NCT06283966?

Participants must meet protocol criteria for COPD (Chronic Obstructive Pulmonary Disease). Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06283966 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease (NCT06283966)

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: AstraZeneca

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (22 items) and avoid the listed exclusions (19 items).

Location: Research Site — Athens, Alabama

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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 period 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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗

A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease (NCT06283966)

🩺 Plain-English Summary (8th-Grade Level)

📋 "Do I Qualify?" — 1-Minute Self Screener

Usually NOT eligible if any of the following apply:

📍 All Participating Trial Locations (921 Sites)

💰 Cost, Insurance & Patient Rights