Clinical Trial

A Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation

Study acronym: ORATOS
Recruiting Phase 4
View on ClinicalTrials.gov →
Summary
The purpose of the study is to evaluate the effect of BGF MDI compared with placebo MDI on cardiac and lung function when administered in participants diagnosed with COPD and hyperinflation.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2025-07-17; most recent amendment 2026-07-23.
Status change: Not Yet Recruiting → Recruiting 2025-12-17
Trial Details
NCT Number NCT07073950
Lead Sponsor AstraZeneca
Collaborators: Parexel
Conditions Chronic Obstructive Pulmonary Disease, Hyperinflation
Enrollment 56 participants
Start Date 2025-11-24
Primary Completion 2027-05-31 (estimated)
Study Completion 2027-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-24