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A Study to Evaluate the Effect of Budesonide, Glycopyrronium, Formoterol Fumarate (BGF) Metered Dose Inhaler (MDI), Budesonide and Formoterol Fumarate (BFF) MDI and Placebo MDI on Exercise Parameters in Participants With Chronic Obstructive Pulmonary Disease (COPD).

NCT06067828 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2026-03-05

No results posted yet for this study

Summary

This study will investigate the effect of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) metered dose inhaler (MDI) compared with Placebo MDI, and Budesonide and Formoterol Fumarate (BFF) MDI on isotime inspiratory capacity (IC) and exercise endurance time.

Conditions

Interventions

DRUG

Treatment A : Budesonide, Glycopyrronium, and Formoterol Fumarate

Randomized participants will receive 2 inhalations of BGF MDI via oral inhalation twice daily (BID).

DRUG

Treatment B: Budesonide and Formoterol Fumarate

Randomized participants will receive 2 inhalations of BFF MDI via oral inhalation BID.

DRUG

Treatment C : Placebo

Randomized participants will receive 2 inhalations of placebo MDI via oral inhalation BID.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2023-10-24
Primary Completion
2026-01-22
Completion
2026-01-22
FDA Drug
Yes

Countries

  • United States
  • Canada
  • China
  • Germany
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
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 NCT06067828 on ClinicalTrials.gov