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A Study to Investigate the Effect on Lung Function of an Approved COPD Treatment (BGF, With HFA Propellant) Compared to BGF Formulated With a Next-Generation Propellant in Participants 40 to 80 Years of Age With COPD

NCT06075095 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 297

Last updated 2025-08-27

No results posted yet for this study

Summary

The purpose of this study is to demonstrate that the lung function effect from orally inhaled BGF delivered via HFO propellant is equivalent to the lung function effect from orally inhaled BGF delivered via HFA propellant in participants with COPD. The study duration for each participant will be approximately 15 to 16 weeks and consist of:

1. A screening and placebo run-in period of approximately 2 weeks prior to first dosing
2. Three treatment periods of approximately 4 weeks each (one period for each of 3 study interventions)
3. A final safety follow-up visit via telephone contact approximately 1 to 2 weeks after the final dose administration Participants will be provided with rescue SABA (albuterol or salbutamol) to be used as needed throughout the study. Participants will attend in-clinic study visits approximately weekly during the screening/run-in period (Visits 1, 2, and 3), then every 4 weeks (Visits 4, 5, and 6) to receive take-home study treatment, measure their lung function, and assess their health and safety

Conditions

  • COPD (Chronic Obstructive Pulmonary Disease)

Interventions

DRUG

BGF MDI HFO 320/14.4/9.6μg

Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart)

DRUG

BGF MDI HFA 320/14.4/9.6 μg

Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart):

DRUG

Placebo MDI HFA

Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2024-01-11
Primary Completion
2025-08-12
Completion
2025-08-12
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Bulgaria
  • Canada
  • Hungary
  • India
  • Malaysia
  • Mexico
  • Philippines
  • Poland
  • South Korea
  • Thailand
  • Turkey (Türkiye)
  • Vietnam

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 NCT06075095 on ClinicalTrials.gov