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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

NCT05573464 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 559

Last updated 2025-09-19

Study results available
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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.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

BGF MDI HFO 320/14.4/9.6 μg

Budesonide, Glycopyrronium, and Formoterol Fumarate

DRUG

BGF MDI HFA 320/14.4/9.6 μg

Budesonide, Glycopyrronium, and Formoterol Fumarate

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-27
Primary Completion
2024-03-26
Completion
2024-03-26
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Bulgaria
  • Canada
  • Germany
  • Mexico
  • Poland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05573464 on ClinicalTrials.gov