Trial Outcomes & Findings for 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 NCT05573464)
NCT ID: NCT05573464
Last Updated: 2025-09-19
Results Overview
To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
559 participants
Primary outcome timeframe
Over 12 weeks
Results posted on
2025-09-19
Participant Flow
All participants randomized were enrolled in the 12-week study. Of these, 120 participants in each arm were assigned (on first-in-study basis) to continue in the extended 52-week study. This is why the number who Started the 52-week treatment period is less than the Protocol Enrollment number.
Participant milestones
| Measure |
BGF MDI HFO 320/14.4/9.6 μg
Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO (HFO-1234ze)
|
BGF MDI HFA 320/14.4/9.6 μg
Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFA
|
|---|---|---|
|
12-week Treatment Period
STARTED
|
280
|
279
|
|
12-week Treatment Period
Started Treatment
|
280
|
278
|
|
12-week Treatment Period
COMPLETED
|
235
|
257
|
|
12-week Treatment Period
NOT COMPLETED
|
45
|
22
|
|
52-week Treatment Period
STARTED
|
120
|
120
|
|
52-week Treatment Period
Assigned 52 Weeks of Treatment and Started Treatment
|
120
|
120
|
|
52-week Treatment Period
COMPLETED
|
86
|
94
|
|
52-week Treatment Period
NOT COMPLETED
|
34
|
26
|
Reasons for withdrawal
| Measure |
BGF MDI HFO 320/14.4/9.6 μg
Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO (HFO-1234ze)
|
BGF MDI HFA 320/14.4/9.6 μg
Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFA
|
|---|---|---|
|
12-week Treatment Period
Discontinued intervention - other reason
|
10
|
4
|
|
12-week Treatment Period
Withdrawal by Subject
|
8
|
5
|
|
12-week Treatment Period
Protocol Violation
|
3
|
1
|
|
12-week Treatment Period
Physician Decision
|
1
|
2
|
|
12-week Treatment Period
Lost to Follow-up
|
2
|
0
|
|
12-week Treatment Period
Adverse Event
|
20
|
9
|
|
12-week Treatment Period
Protocol-specified withdrawal criterion met
|
1
|
0
|
|
12-week Treatment Period
Randomised, not treated
|
0
|
1
|
|
52-week Treatment Period
Discontinued intervention - other reason
|
9
|
8
|
|
52-week Treatment Period
Withdrawal by Subject
|
9
|
5
|
|
52-week Treatment Period
Protocol Violation
|
1
|
1
|
|
52-week Treatment Period
Physician Decision
|
2
|
2
|
|
52-week Treatment Period
Lost to Follow-up
|
1
|
1
|
|
52-week Treatment Period
Adverse Event
|
11
|
8
|
|
52-week Treatment Period
Death
|
1
|
1
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
BGF MDI HFO 320/14.4/9.6 μg
n=280 Participants
Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO (HFO-1234ze)
|
BGF MDI HFA 320/14.4/9.6 μg
n=278 Participants
Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFA
|
Total
n=558 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
86 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
194 Participants
n=5 Participants
|
187 Participants
n=7 Participants
|
381 Participants
n=5 Participants
|
|
Age, Continuous
|
68.5 years
n=5 Participants
|
68.0 years
n=7 Participants
|
68.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
112 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
168 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
315 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
43 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
237 Participants
n=5 Participants
|
228 Participants
n=7 Participants
|
465 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
273 Participants
n=5 Participants
|
272 Participants
n=7 Participants
|
545 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Over 12 weeksPopulation: 12-week safety analysis set
To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD
Outcome measures
| Measure |
BGF MDI HFO 320/14.4/9.6 μg
n=280 Participants
Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO (HFO-1234ze)
|
BGF MDI HFA 320/14.4/9.6 μg
n=278 Participants
Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFA
|
|---|---|---|
|
Number and Percentage of Participants With Serious Adverse Events
Any serious adverse event
|
15 Participants
|
12 Participants
|
|
Number and Percentage of Participants With Serious Adverse Events
No serious adverse events
|
265 Participants
|
266 Participants
|
PRIMARY outcome
Timeframe: Over 52 weeksPopulation: 52-week safety analysis set
To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD
Outcome measures
| Measure |
BGF MDI HFO 320/14.4/9.6 μg
n=120 Participants
Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO (HFO-1234ze)
|
BGF MDI HFA 320/14.4/9.6 μg
n=120 Participants
Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFA
|
|---|---|---|
|
Number and Percentage of Participants With Serious Adverse Events
Any serious adverse event
|
17 Participants
|
16 Participants
|
|
Number and Percentage of Participants With Serious Adverse Events
No serious adverse events
|
103 Participants
|
104 Participants
|
PRIMARY outcome
Timeframe: Over 12 weeksPopulation: 12-week safety analysis set
To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD
Outcome measures
| Measure |
BGF MDI HFO 320/14.4/9.6 μg
n=280 Participants
Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO (HFO-1234ze)
|
BGF MDI HFA 320/14.4/9.6 μg
n=278 Participants
Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFA
|
|---|---|---|
|
Number and Percentage of Participants With Non-serious Adverse Events >5%
Any non-serious adverse event at the threshold cut-off greater than 5%
|
46 Participants
|
47 Participants
|
|
Number and Percentage of Participants With Non-serious Adverse Events >5%
No non-serious adverse events at the threshold cut-off greater than 5%
|
234 Participants
|
231 Participants
|
PRIMARY outcome
Timeframe: Over 52 weeksPopulation: 52-week safety analysis set
To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD
Outcome measures
| Measure |
BGF MDI HFO 320/14.4/9.6 μg
n=120 Participants
Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO (HFO-1234ze)
|
BGF MDI HFA 320/14.4/9.6 μg
n=120 Participants
Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFA
|
|---|---|---|
|
Number and Percentage of Participants With Non-serious Adverse Events >5%
Any non-serious adverse event at the threshold cut-off greater than 5%
|
46 Participants
|
67 Participants
|
|
Number and Percentage of Participants With Non-serious Adverse Events >5%
No non-serious adverse events at the threshold cut-off greater than 5%
|
74 Participants
|
53 Participants
|
PRIMARY outcome
Timeframe: Over 12 weeksPopulation: 12-week safety analysis set
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.
Outcome measures
| Measure |
BGF MDI HFO 320/14.4/9.6 μg
n=280 Participants
Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO (HFO-1234ze)
|
BGF MDI HFA 320/14.4/9.6 μg
n=278 Participants
Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFA
|
|---|---|---|
|
Number and Percentage of Participants With Adverse Events of Special Interest
Any adverse event of special interest
|
52 Participants
|
55 Participants
|
|
Number and Percentage of Participants With Adverse Events of Special Interest
No adverse events of special interest
|
228 Participants
|
223 Participants
|
PRIMARY outcome
Timeframe: Over 52 weeksPopulation: 52-week safety analysis set
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.
Outcome measures
| Measure |
BGF MDI HFO 320/14.4/9.6 μg
n=120 Participants
Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO (HFO-1234ze)
|
BGF MDI HFA 320/14.4/9.6 μg
n=120 Participants
Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFA
|
|---|---|---|
|
Number and Percentage of Participants With Adverse Events of Special Interest
Any adverse event of special interest
|
40 Participants
|
47 Participants
|
|
Number and Percentage of Participants With Adverse Events of Special Interest
No adverse events of special interest
|
80 Participants
|
73 Participants
|
Adverse Events
BGF MDI HFO 320/14.4/9.6 μg
Serious events: 25 serious events
Other events: 64 other events
Deaths: 1 deaths
BGF MDI HFA 320/14.4/9.6 μg
Serious events: 24 serious events
Other events: 80 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
BGF MDI HFO 320/14.4/9.6 μg
n=280 participants at risk
Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO (HFO-1234ze)
|
BGF MDI HFA 320/14.4/9.6 μg
n=278 participants at risk
Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFA
|
|---|---|---|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.00%
0/280 • 52 weeks
|
0.36%
1/278 • Number of events 1 • 52 weeks
|
|
Nervous system disorders
Seizure
|
0.36%
1/280 • Number of events 1 • 52 weeks
|
0.00%
0/278 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.36%
1/280 • Number of events 1 • 52 weeks
|
0.00%
0/278 • 52 weeks
|
|
Nervous system disorders
Trigeminal palsy
|
0.00%
0/280 • 52 weeks
|
0.36%
1/278 • Number of events 1 • 52 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/280 • 52 weeks
|
0.36%
1/278 • Number of events 1 • 52 weeks
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/280 • 52 weeks
|
0.36%
1/278 • Number of events 1 • 52 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
0.71%
2/280 • Number of events 2 • 52 weeks
|
0.36%
1/278 • Number of events 1 • 52 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.36%
1/280 • Number of events 1 • 52 weeks
|
0.00%
0/278 • 52 weeks
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/280 • 52 weeks
|
0.36%
1/278 • Number of events 1 • 52 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.71%
2/280 • Number of events 2 • 52 weeks
|
0.00%
0/278 • 52 weeks
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/280 • 52 weeks
|
0.36%
1/278 • Number of events 1 • 52 weeks
|
|
Cardiac disorders
Myocarditis
|
0.36%
1/280 • Number of events 1 • 52 weeks
|
0.00%
0/278 • 52 weeks
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.36%
1/280 • Number of events 1 • 52 weeks
|
0.00%
0/278 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.36%
1/280 • Number of events 1 • 52 weeks
|
0.00%
0/278 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.1%
6/280 • Number of events 6 • 52 weeks
|
3.2%
9/278 • Number of events 9 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/280 • 52 weeks
|
0.36%
1/278 • Number of events 1 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/280 • 52 weeks
|
0.36%
1/278 • Number of events 1 • 52 weeks
|
|
Gastrointestinal disorders
Gastric varices
|
0.36%
1/280 • Number of events 1 • 52 weeks
|
0.00%
0/278 • 52 weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.36%
1/280 • Number of events 1 • 52 weeks
|
0.00%
0/278 • 52 weeks
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/280 • 52 weeks
|
0.36%
1/278 • Number of events 1 • 52 weeks
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.36%
1/280 • Number of events 1 • 52 weeks
|
0.00%
0/278 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/280 • 52 weeks
|
0.36%
1/278 • Number of events 1 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.71%
2/280 • Number of events 2 • 52 weeks
|
0.00%
0/278 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Vertebral lateral recess stenosis
|
0.36%
1/280 • Number of events 1 • 52 weeks
|
0.00%
0/278 • 52 weeks
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/280 • 52 weeks
|
0.36%
1/278 • Number of events 1 • 52 weeks
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/280 • 52 weeks
|
0.72%
2/278 • Number of events 2 • 52 weeks
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.36%
1/280 • Number of events 1 • 52 weeks
|
0.00%
0/278 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/280 • 52 weeks
|
0.36%
1/278 • Number of events 1 • 52 weeks
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.36%
1/280 • Number of events 1 • 52 weeks
|
0.36%
1/278 • Number of events 1 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/280 • 52 weeks
|
0.36%
1/278 • Number of events 1 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/280 • 52 weeks
|
0.36%
1/278 • Number of events 1 • 52 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/280 • 52 weeks
|
0.36%
1/278 • Number of events 1 • 52 weeks
|
|
Nervous system disorders
Ischaemic stroke
|
0.36%
1/280 • Number of events 1 • 52 weeks
|
0.00%
0/278 • 52 weeks
|
|
Infections and infestations
Atypical pneumonia
|
0.36%
1/280 • Number of events 1 • 52 weeks
|
0.00%
0/278 • 52 weeks
|
|
Infections and infestations
Bronchitis
|
0.36%
1/280 • Number of events 1 • 52 weeks
|
0.00%
0/278 • 52 weeks
|
|
Infections and infestations
COVID-19
|
0.00%
0/280 • 52 weeks
|
0.36%
1/278 • Number of events 1 • 52 weeks
|
|
Infections and infestations
COVID-19 pneumonia
|
0.36%
1/280 • Number of events 1 • 52 weeks
|
0.00%
0/278 • 52 weeks
|
|
Infections and infestations
Pneumonia
|
0.71%
2/280 • Number of events 2 • 52 weeks
|
0.36%
1/278 • Number of events 1 • 52 weeks
|
|
Infections and infestations
Pneumonia haemophilus
|
0.36%
1/280 • Number of events 1 • 52 weeks
|
0.00%
0/278 • 52 weeks
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/280 • 52 weeks
|
0.36%
1/278 • Number of events 1 • 52 weeks
|
|
Infections and infestations
Pneumonia streptococcal
|
0.36%
1/280 • Number of events 1 • 52 weeks
|
0.00%
0/278 • 52 weeks
|
|
Infections and infestations
Sepsis
|
0.36%
1/280 • Number of events 1 • 52 weeks
|
0.00%
0/278 • 52 weeks
|
Other adverse events
| Measure |
BGF MDI HFO 320/14.4/9.6 μg
n=280 participants at risk
Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO (HFO-1234ze)
|
BGF MDI HFA 320/14.4/9.6 μg
n=278 participants at risk
Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFA
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.1%
20/280 • Number of events 24 • 52 weeks
|
10.8%
30/278 • Number of events 39 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
18.6%
52/280 • Number of events 68 • 52 weeks
|
21.6%
60/278 • Number of events 75 • 52 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI may not independently publish results until one of the following occurs: 1. multicentre primary publication is published; 2. no multicentre primary publication is submitted within 2 years after conclusion; 3. Sponsor confirms in writing there will be no multicentre primary publication. PI shall provide the Sponsor with copies of any materials relating to the study that they intend to publish or make presentations relating to, at least 30 days in advance.
- Publication restrictions are in place
Restriction type: OTHER