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Trial · NCT06067828

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, Phase 3, Completed, AstraZeneca

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. 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). Trials, record NCT06067828. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06067828

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
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).
NCT number
NCT06067828
Status
Completed
Phases
Phase 3
Enrollment
171 participants, actual
Lead sponsor
AstraZeneca
Conditions
Chronic Obstructive Pulmonary Disease
Interventions
Treatment A : Budesonide, Glycopyrronium, and Formoterol Fumarate, Treatment B: Budesonide and Formoterol Fumarate, Treatment C : Placebo
First posted
2023-10-05
Last updated
2026-03-05

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange from baseline in isotime Inspiratory capacity (IC)2 weeks post-treatmentTo assess the effect of BGF MDI relative to Placebo MDI and BGF MDI relative to BFF MDI on dynamic hyperinflation in participants with COPD.
SecondaryChange from baseline in constant work rate cycle ergometry endurance time2 weeks post-treatmentTo assess the effect of BGF MDI relative to Placebo MDI, BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on exercise endurance time in participants with COPD.
SecondaryChange from baseline in Isotime dyspnea (NRS)2 weeks post-treatmentTo assess the effect of BGF MDI relative to Placebo MDI, BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on Isotime dyspnea in participants with COPD.
SecondaryChange from baseline in functional residual capacity (FRC)2 weeks post-treatmentTo assess the effect of BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on FRC in participants with COPD.
SecondaryChange from baseline in total lung capacity (TLC)2 weeks post-treatmentTo assess the effect of BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on TLC in participants with COPD.
SecondaryChange from baseline in residual volume (RV)2 weeks post-treatmentTo assess the effect of BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on RV in participants with COPD.
SecondaryChange from baseline in RV/TLC2 weeks post-treatmentTo assess the effect of BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on RV/TLC in participants with COPD.
SecondaryChange from baseline in specific airway conductance (sGaw)2 weeks post-treatmentTo assess the effect of BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on sGaw in participants with COPD.
SecondaryChange from baseline in static Inspiratory capacity (IC)2 weeks post-treatmentTo assess the effect of BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on static IC in participants with COPD.
SecondaryNumber of participants with serious adverse events (SAEs) and adverse event leading to discontinuation of study intervention (DAEs).2 weeks post-treatmentTo assess the safety and tolerability of BGF MDI and BFF MDI.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT06067828

GET https://conductscience.org/api/trials/v1/NCT06067828/registered