Budesonide/glycopyrronium/formoterol inhaler versus placebo for heart and lung function in COPD with hyperinflation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled, crossover Phase IV study gives adults with COPD and documented hyperinflation two 21-day treatment periods of either the combination BGF metered-dose inhaler or matching placebo, with participants switching treatments in the second period. After screening and baseline assessments, cardiac and pulmonary function tests are performed before and after each treatment period to compare effects on heart performance and lung deflation. Eligible participants are current or former smokers on maintenance inhaled COPD therapy who meet spirometric and hyperinflation criteria. The trial is multicenter and includes a follow-up visit after the crossover periods.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Current or former smoker with a history of ≥ 10 pack-years of tobacco smoking.
* A diagnosis of COPD confirmed by a post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) \< 0.7.
* At Visit 1: A pre-bronchodilator FEV1 \< 80%.
* At Visit 1: Peripheral blood eosinophil count \< 300 cells/cubic millimeter (mm³), with no recorded history of eosinophil count \> 300 cells/mm³ in the past 12 months.
* At Visit 1: Modified Medical Research Council (mMRC) ≥ 1.
* At Visit 2: A pre-bronchodilator functional residual capacity (FRC) of \> 135% of predicted normal FRC.
* At Visit 2: A post-bronchodilator FEV1 ≥ 30% and \< 80% of the predicted normal value.
* Participants must be on mono-, dual-, or triple-inhaled maintenance COPD treatment.
* Female participants must either be not of childbearing potential or using a form of highly effective birth control.
* All women of child bearing potential must have a negative pregnancy test at the Visit 1.

Exclusion Criteria:

* A current diagnosis of asthma, asthma-COPD overlap, or any other chronic respiratory disease other than COPD, such as alpha-1 antitrypsin deficiency, active tuberculosis, lung cancer, lung fibrosis, sarcoidosis, interstitial lung disease, and pulmonary hypertension.
* History of a COPD exacerbation that required hospitalisation, or 2 or more COPD exacerbations that required systemic corticosteroids.
* History of myocardial infarction or acute coronary syndrome.
* History or current clinically significant atrial or ventricular arrhythmia to be confirmed by electrocardiogram (ECG).
* Participants with a cardiac implantable electronic device, including pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy.
* Participants with ECG QTcF interval at Visit 1 \> 460 milliseconds (ms) for males and \> 480 ms for females.
* Participants who have had a respiratory tract infection within 8 weeks prior to Visit 1 and/or during the screening/run-in period.
* Participants with lung lobectomy, lung volume reduction (during the study and within 3 months of Visit 1), or lung transplantation.

Where it's running

• Research Site
  Ahrensburg, Germany Recruiting
• Research Site
  Berlin, Germany Recruiting
• Research Site
  Frankfurt, Germany Recruiting
• Research Site
  Hanover, Germany Recruiting
• Research Site
  London, United Kingdom Recruiting
• Research Site
  Manchester, United Kingdom Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.