Budesonide, Glycopyrronium, and Formoterol for COPD

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

Recruiting Phase 3 Interventional Study
COPD (Chronic Obstructive Pulmonary Disease)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
40 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
5,000 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for

This trial is looking for adults aged 40 to 80 with Chronic Obstructive Pulmonary Disease (COPD). Participants will receive a combination inhaler treatment and attend study visits for assessments.

Are You a Good Fit for This Trial?
Rules you out AsthmaHeart diseaseLung cancerActive tuberculosis

You may be able to join if

  • I am between 40 and 80 years old.
  • I have been diagnosed with COPD.
  • I am a current or former smoker with at least 10 pack-years.
  • I have a CAT score of 10 or higher.
  • I have a blood eosinophil count of 100 cells/mm3 or more.
  • I have a cardiovascular disease risk factor.
  • I can follow the study's visit requirements.
  • I can provide signed informed consent.

You may not be able to join if

  • I have active asthma or other significant lung disease.
  • I have had a heart or lung transplant.
  • I have unstable or life-threatening heart disease.
  • I have pneumonia or severe COPD flare-ups not healed for 8 weeks.
  • I have used maintenance inhaled corticosteroids in the last year.
  • I am currently pregnant or breastfeeding.
  • I have had lung cancer treatment in the last 5 years.
  • I cannot stop using prohibited medications.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 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% …
Contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

CONTACT