Trial · NCT06075095
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, Phase 3, Completed, AstraZeneca
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT06075095. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06075095
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT06075095
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 297 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease)
- Interventions
- BGF MDI HFO 320/14.4/9.6μg, BGF MDI HFA 320/14.4/9.6 μg, Placebo MDI HFA
- First posted
- 2023-10-10
- Last updated
- 2025-08-27
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in FEV1 AUC (0-4) | Change from baseline at Day 29 | To assess the equivalence of BGF MDI HFO relative to BGF MDI HFA on lung function in participants with COPD |
| Primary | Change in morning pre-dose trough FEV1 | Change from baseline at Day 29 | To assess the equivalence of BGF MDI HFO relative to BGF MDI HFA on lung function in participants with COPD |
| Primary | Changes in FEV1 AUC (0-4) | Change from baseline at Day 29 | To demonstrate assay sensitivity via superiority of BGF MDI HFA relative to placebo MDI HFA on lung function in participants with COPD |
| Primary | Change in morning pre-dose trough FEV1 | Change from baseline at Day 29 | To demonstrate assay sensitivity via superiority of BGF MDI HFA relative to placebo MDI HFA on lung function in participants with COPD |
| Other | Number (and percentage) of participants with adverse Events | Over 16 weeks and per treatment group per 4 weeks treatment period | To assess the safety and tolerability of BGF MDI HFO compared to BGF MDI HFA in participants with COPD |
| Other | Number (and percentage) of participants with with potentially clinically significant changes in Blood Pressure | Over 16 weeks and per treatment group per 4 weeks treatment period | To assess the safety and tolerability of BGF MDI HFO compared to BGF MDI HFA in participants with COPD |
| Other | Number (and percentage) of participants with potentially clinically significant changes in pulse rate | Over 16 weeks and per treatment group per 4 weeks treatment period | To assess the safety and tolerability of BGF MDI HFO compared to BGF MDI HFA in participants with COPD |
| Other | Changes in FEV1 AUC (0-4) | Change from baseline at TP 1 Day 1 | To determine responsiveness to study intervention for TP 1 |
| Other | Time to onset of action | Change from baseline at TP 1 Day 1 | Time to onset defined as the first post-dose timepoint where the mean change from baseline in FEV1 exceeds 100 mL on TP 1 Day 1 |
| Other | Changes in FEV1 AUC (0-4) | Change from baseline at Day 29 | To assess superiority of BGF MDI HFO relative to placebo MDI HFA on lung function, pre- and post-dose, in participants with COPD |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
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.
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/NCT06075095
GET https://conductscience.org/api/trials/v1/NCT06075095/registered