A Study to Assess the Safety of Budesonide/Glycopyrronium/Formoterol Fumarate With a Next-Generation Propellant in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Summary

This is a 12-week (with an extension to 52 weeks in a subset of participants) study comparing the safety of BGF MDI HFO twice daily (BID) with BGF MDI HFA BID in participants with moderate to very severe COPD.

Timeline

Start

2022-09-27

Primary completion

2024-03-26

Completion

2024-03-26

Publications

• Usmani OS, Martinez FJ, Pandya H, Camiolo M, Bednarczyk A, Kucz K, Kokot M, Gottfridsson C, Aurivillius M, Pettersson L, Mei J, Skansen K, Bell JL, Petullo D, Collison K, Bondarov P, Jassal M, Patel M. Safety of budesonide/glycopyrronium/formoterol fumarate dihydrate delivered by HFO-1234ze versus HFA-134a in chronic obstructive pulmonary disease: a phase 3, multi-site, randomised, double-blind, parallel-group, active-comparator study. EClinicalMedicine. 2025 Aug 12;87:103402. doi: 10.1016/j.eclinm.2025.103402. eCollection 2025 Sep.

Drugs

Indications