RecruitingCOPD (Chronic Obstructive Pulmonary Disease)

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

Eligible age

40–80 yrs

Accepts

All genders

Locations

39 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

About this study

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.

Sponsor: AstraZeneca

You may qualify if…

✓ 1. Male or female participants must be 40 to 80 years of age inclusive, at the time of signing
✓ the ICF.
✓ 2. Demonstrate acceptable MDI administration technique at Visit 1 (V1) and Visit 2 (V2)
✓ 3. A diagnosis of COPD confirmed by a post-bronchodilator FEV1/FVC ratio \< 70%
✓ at V1.
✓ 4. 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
✓ months prior to V1.

You may not qualify if…

✕ 1. 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.
✕ 2. End-stage renal disease requiring renal replacement therapy
✕ 3. History of heart or lung transplant or actively listed for heart or lung transplant.
✕ 4. Implanted left ventricular assist device or implant anticipated in \< 3 months.
✕ 5. History of lung cancer and/or treatment for lung cancer within the 5 years prior to Visit 1.
✕ 6. Unstable or life-threatening cardiac disease - participants with any of the following at Visit 1 would be excluded:
✕ 1. An MI or unstable angina in the last 8 weeks
✕ 2. Unstable or life-threatening cardiac arrhythmia requiring intervention in the last 8 weeks.