Trial · NCT05573464

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, Phase 3, Completed, AstraZeneca; results first posted 2025-09-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT05573464. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05573464

On this page

Trial

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

Title: 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
NCT number: NCT05573464
Status: Completed
Phases: Phase 3
Enrollment: 559 participants, actual
Lead sponsor: AstraZeneca
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Interventions: BGF MDI HFO 320/14.4/9.6 μg, BGF MDI HFA 320/14.4/9.6 μg
First posted: 2022-10-10
Last updated: 2025-09-19
Other registries' IDs: eudract:2022-001476-33
Results first posted: 2025-09-19

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Number and Percentage of Participants With Serious Adverse Events	Over 12 weeks	To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD
Primary	Number and Percentage of Participants With Serious Adverse Events	Over 52 weeks	To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD
Primary	Number and Percentage of Participants With Non-serious Adverse Events >5%	Over 12 weeks	To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD
Primary	Number and Percentage of Participants With Non-serious Adverse Events >5%	Over 52 weeks	To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD
Primary	Number and Percentage of Participants With Adverse Events of Special Interest	Over 12 weeks	To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD. Adverse events of special interest in this study are respiratory events such as dysphonia, cough, dyspnea, wheezing, paradoxical bronchospasm, bronchospasm, and COPD exacerbations.
Primary	Number and Percentage of Participants With Adverse Events of Special Interest	Over 52 weeks	To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD. Adverse events of special interest in this study are respiratory events such as dysphonia, cough, dyspnea, wheezing, paradoxical bronchospasm, bronchospasm, and COPD exacerbations.

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number and Percentage of Participants With Serious Adverse Events	Over 12 weeks	12-week safety analysis set	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number and Percentage of Participants With Serious Adverse Events	Over 52 weeks	52-week safety analysis set	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number and Percentage of Participants With Non-serious Adverse Events >5%	Over 12 weeks	12-week safety analysis set	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number and Percentage of Participants With Non-serious Adverse Events >5%	Over 52 weeks	52-week safety analysis set	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number and Percentage of Participants With Adverse Events of Special Interest	Over 12 weeks	12-week safety analysis set	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number and Percentage of Participants With Adverse Events of Special Interest	Over 52 weeks	52-week safety analysis set	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group24

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

Outcome	Group	Category	Value	Units
Number and Percentage of Participants With Serious Adverse Events	BGF MDI HFO 320/14.4/9.6 μg	Any serious adverse event	15	Participants
Number and Percentage of Participants With Serious Adverse Events	BGF MDI HFA 320/14.4/9.6 μg	Any serious adverse event	12	Participants
Number and Percentage of Participants With Serious Adverse Events	BGF MDI HFO 320/14.4/9.6 μg	No serious adverse events	265	Participants
Number and Percentage of Participants With Serious Adverse Events	BGF MDI HFA 320/14.4/9.6 μg	No serious adverse events	266	Participants
Number and Percentage of Participants With Serious Adverse Events	BGF MDI HFO 320/14.4/9.6 μg	Any serious adverse event	17	Participants
Number and Percentage of Participants With Serious Adverse Events	BGF MDI HFA 320/14.4/9.6 μg	Any serious adverse event	16	Participants
Number and Percentage of Participants With Serious Adverse Events	BGF MDI HFO 320/14.4/9.6 μg	No serious adverse events	103	Participants
Number and Percentage of Participants With Serious Adverse Events	BGF MDI HFA 320/14.4/9.6 μg	No serious adverse events	104	Participants
Number and Percentage of Participants With Non-serious Adverse Events >5%	BGF MDI HFO 320/14.4/9.6 μg	Any non-serious adverse event at the threshold cut-off greater than 5%	46	Participants
Number and Percentage of Participants With Non-serious Adverse Events >5%	BGF MDI HFA 320/14.4/9.6 μg	Any non-serious adverse event at the threshold cut-off greater than 5%	47	Participants

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow16

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

Period	Milestone	Group	Participants
12-week Treatment Period	STARTED	BGF MDI HFO 320/14.4/9.6 μg	280
12-week Treatment Period	STARTED	BGF MDI HFA 320/14.4/9.6 μg	279
12-week Treatment Period	Started Treatment	BGF MDI HFO 320/14.4/9.6 μg	280
12-week Treatment Period	Started Treatment	BGF MDI HFA 320/14.4/9.6 μg	278
12-week Treatment Period	COMPLETED	BGF MDI HFO 320/14.4/9.6 μg	235
12-week Treatment Period	COMPLETED	BGF MDI HFA 320/14.4/9.6 μg	257
12-week Treatment Period	NOT COMPLETED	BGF MDI HFO 320/14.4/9.6 μg	45
12-week Treatment Period	NOT COMPLETED	BGF MDI HFA 320/14.4/9.6 μg	22
52-week Treatment Period	STARTED	BGF MDI HFO 320/14.4/9.6 μg	120
52-week Treatment Period	STARTED	BGF MDI HFA 320/14.4/9.6 μg	120

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events88

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

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nasopharyngitis	Infections and infestations	BGF MDI HFO 320/14.4/9.6 μg	20	280	24
other	Nasopharyngitis	Infections and infestations	BGF MDI HFA 320/14.4/9.6 μg	30	278	39
other	Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	BGF MDI HFO 320/14.4/9.6 μg	52	280	68
other	Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	BGF MDI HFA 320/14.4/9.6 μg	60	278	75
serious	Atypical pneumonia	Infections and infestations	BGF MDI HFO 320/14.4/9.6 μg	1	280	1
serious	Atypical pneumonia	Infections and infestations	BGF MDI HFA 320/14.4/9.6 μg	0	278	0
serious	Bronchitis	Infections and infestations	BGF MDI HFO 320/14.4/9.6 μg	1	280	1
serious	Bronchitis	Infections and infestations	BGF MDI HFA 320/14.4/9.6 μg	0	278	0
serious	COVID-19	Infections and infestations	BGF MDI HFO 320/14.4/9.6 μg	0	280	0
serious	COVID-19	Infections and infestations	BGF MDI HFA 320/14.4/9.6 μg	1	278	1

1 to 10 of 88Source ClinicalTrials.gov

See all 88 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	BGF MDI HFO 320/14.4/9.6 μg	1	280
Total, all-cause mortality	BGF MDI HFA 320/14.4/9.6 μg	1	278
Total, other adverse events	BGF MDI HFO 320/14.4/9.6 μg	64	280
Total, other adverse events	BGF MDI HFA 320/14.4/9.6 μg	80	278
Total, serious adverse events	BGF MDI HFO 320/14.4/9.6 μg	25	280
Total, serious adverse events	BGF MDI HFA 320/14.4/9.6 μg	24	278

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40831469	DERIVED

Source PubMed

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 comparisons2

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

Comparison	Source
BGF MDI HFO 320/14.4/9.6 μg vs BGF MDI HFA 320/14.4/9.6 μg: deaths from any cause	Trial comparisons
BGF MDI HFO 320/14.4/9.6 μg vs BGF MDI HFA 320/14.4/9.6 μg: serious adverse events	Trial comparisons

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/NCT05573464

GET https://conductscience.org/api/trials/v1/NCT05573464/results?page=2

API reference For AI assistants