Trial Outcomes & Findings for Study to Assess Bronchospasm Potentially Induced by Next-Generation Propellant vs HFA Propellant in an MDI in Participants With Well/Partially Controlled Asthma (NCT NCT05850494)
NCT ID: NCT05850494
Last Updated: 2026-02-06
Results Overview
The change from baseline (30 minutes pre-dose) in normalized FEV1 AUC0-15 min postdose induced by Treatment HFO was compared with Treatment HFA.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
52 participants
Primary outcome timeframe
30 minutes prior to dosing and at 5, 15, and 30 minutes post-dose
Results posted on
2026-02-06
Participant Flow
Participant milestones
| Measure |
Sequence HFA-HFO
HFA propellant only metered-dose inhaler (4 inhalations per dose - reference formulation) then HFO propellant only metered-dose inhaler (4 inhalations per dose - test formulation)
|
Sequence HFO-HFA
HFO propellant only metered-dose inhaler (4 inhalations per dose - test formulation) then HFA propellant only metered-dose inhaler (4 inhalations per dose - reference formulation)
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
|
Overall Study
COMPLETED
|
26
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Full Analysis Set
Baseline characteristics by cohort
| Measure |
Sequence HFO-HFA
n=26 Participants
HFO propellant only metered-dose inhaler (4 inhalations per dose - test formulation) then HFA propellant only metered-dose inhaler (4 inhalations per dose - reference formulation)
|
Sequence HFA-HFO
n=26 Participants
HFA propellant only metered-dose inhaler (4 inhalations per dose - reference formulation) then HFO propellant only metered-dose inhaler (4 inhalations per dose - test formulation)
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.8 Years
STANDARD_DEVIATION 9.78 • n=192 Participants
|
30.9 Years
STANDARD_DEVIATION 7.86 • n=170 Participants
|
32.4 Years
STANDARD_DEVIATION 8.90 • n=185 Participants
|
|
Age, Customized
18-45
|
26 Participants
n=192 Participants • Full Analysis Set
|
26 Participants
n=170 Participants • Full Analysis Set
|
52 Participants
n=185 Participants • Full Analysis Set
|
|
Age, Customized
Missing
|
0 Participants
n=192 Participants • Full Analysis Set
|
0 Participants
n=170 Participants • Full Analysis Set
|
0 Participants
n=185 Participants • Full Analysis Set
|
|
Sex: Female, Male
Female
|
17 Participants
n=192 Participants
|
19 Participants
n=170 Participants
|
36 Participants
n=185 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=192 Participants
|
7 Participants
n=170 Participants
|
16 Participants
n=185 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=192 Participants
|
7 Participants
n=170 Participants
|
15 Participants
n=185 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=192 Participants
|
19 Participants
n=170 Participants
|
37 Participants
n=185 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=192 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=185 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=192 Participants
|
0 Participants
n=170 Participants
|
1 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=192 Participants
|
1 Participants
n=170 Participants
|
1 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=192 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=192 Participants
|
4 Participants
n=170 Participants
|
7 Participants
n=185 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=192 Participants
|
21 Participants
n=170 Participants
|
43 Participants
n=185 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=192 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=192 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=185 Participants
|
|
Country
USA
|
26 Participants
n=192 Participants
|
26 Participants
n=170 Participants
|
52 Participants
n=185 Participants
|
PRIMARY outcome
Timeframe: 30 minutes prior to dosing and at 5, 15, and 30 minutes post-dosePopulation: Primary Analysis Set
The change from baseline (30 minutes pre-dose) in normalized FEV1 AUC0-15 min postdose induced by Treatment HFO was compared with Treatment HFA.
Outcome measures
| Measure |
Treatment HFO
n=52 Participants
HFO propellant only metered-dose inhaler; 4 inhalations per dose - test formulation
|
Treatment HFA
n=52 Participants
HFA propellant only metered-dose inhaler; 4 inhalations per dose - reference formulation
|
|---|---|---|
|
Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0 to 15 Minutes (AUC0-15 Min) Post-dose
Baseline FEV1 (30 minutes pre-dose)
|
2.969 Litres
Standard Deviation 0.6660
|
2.970 Litres
Standard Deviation 0.6463
|
|
Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0 to 15 Minutes (AUC0-15 Min) Post-dose
Normalized FEV1 AUC0-15 min
|
2.955 Litres
Standard Deviation 0.6577
|
2.965 Litres
Standard Deviation 0.6474
|
|
Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0 to 15 Minutes (AUC0-15 Min) Post-dose
Change from baseline in normalized FEV1 AUC0-15 min post-dose
|
-0.014 Litres
Standard Deviation 0.0794
|
-0.004 Litres
Standard Deviation 0.0565
|
SECONDARY outcome
Timeframe: 30 minutes prior to dosing and at 5 and 15 minutes post-dosePopulation: Safety Set
The potential of Treatment HFO to induce bronchospasm was compared with Treatment HFA. The number of participants with bronchospasm events post-dose (5 or 15 minutes post-dose) from baseline (30 minutes pre-dose) for each treatment is presented. An event of bronchospasm is defined as a reduction in FEV1 of \>15% from baseline (i.e. the FEV1 value obtained within 30 minutes prior to study intervention administration) at 5 or 15 minutes post-dose, with associated symptoms of wheezing, shortness of breath, or cough.
Outcome measures
| Measure |
Treatment HFO
n=52 Participants
HFO propellant only metered-dose inhaler; 4 inhalations per dose - test formulation
|
Treatment HFA
n=52 Participants
HFA propellant only metered-dose inhaler; 4 inhalations per dose - reference formulation
|
|---|---|---|
|
Number of Participants With Bronchospasm Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From screening (Day - 14) to the last dose (day 8) + 7 daysPopulation: Safety Set
The number of AEs, SAEs, and AESIs for Treatment HFO and Treatment HFA are presented.
Outcome measures
| Measure |
Treatment HFO
n=52 Participants
HFO propellant only metered-dose inhaler; 4 inhalations per dose - test formulation
|
Treatment HFA
n=52 Participants
HFA propellant only metered-dose inhaler; 4 inhalations per dose - reference formulation
|
|---|---|---|
|
Safety and Tolerability Evaluated in Terms of Adverse Events (AEs)
Any AE leading to discontinuation of investigational product
|
0 Events
|
0 Events
|
|
Safety and Tolerability Evaluated in Terms of Adverse Events (AEs)
Any AE
|
2 Events
|
4 Events
|
|
Safety and Tolerability Evaluated in Terms of Adverse Events (AEs)
Serious AE (SAE)
|
0 Events
|
0 Events
|
|
Safety and Tolerability Evaluated in Terms of Adverse Events (AEs)
Any SAE with outcome death
|
0 Events
|
0 Events
|
|
Safety and Tolerability Evaluated in Terms of Adverse Events (AEs)
Any possibly related AE
|
1 Events
|
0 Events
|
|
Safety and Tolerability Evaluated in Terms of Adverse Events (AEs)
Any possibly related SAE
|
0 Events
|
0 Events
|
|
Safety and Tolerability Evaluated in Terms of Adverse Events (AEs)
Any AE of special interest
|
0 Events
|
0 Events
|
Adverse Events
Treatment HFO
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment HFA
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment HFO
n=52 participants at risk
HFO propellant only metered-dose inhaler; 4 inhalations per dose - test formulation
|
Treatment HFA
n=52 participants at risk
HFA propellant only metered-dose inhaler; 4 inhalations per dose - reference formulation
|
|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/52 • The adverse events with start date on or after the date of treatment during treatment period 1 up to (and including) 7 days after the last dose date were included, up to 20 days.
Subjects with multiple occurrences in the same category are counted once per category regardless of the number of occurrences.
|
1.9%
1/52 • Number of events 1 • The adverse events with start date on or after the date of treatment during treatment period 1 up to (and including) 7 days after the last dose date were included, up to 20 days.
Subjects with multiple occurrences in the same category are counted once per category regardless of the number of occurrences.
|
|
General disorders
Pyrexia
|
1.9%
1/52 • Number of events 1 • The adverse events with start date on or after the date of treatment during treatment period 1 up to (and including) 7 days after the last dose date were included, up to 20 days.
Subjects with multiple occurrences in the same category are counted once per category regardless of the number of occurrences.
|
0.00%
0/52 • The adverse events with start date on or after the date of treatment during treatment period 1 up to (and including) 7 days after the last dose date were included, up to 20 days.
Subjects with multiple occurrences in the same category are counted once per category regardless of the number of occurrences.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/52 • The adverse events with start date on or after the date of treatment during treatment period 1 up to (and including) 7 days after the last dose date were included, up to 20 days.
Subjects with multiple occurrences in the same category are counted once per category regardless of the number of occurrences.
|
1.9%
1/52 • Number of events 1 • The adverse events with start date on or after the date of treatment during treatment period 1 up to (and including) 7 days after the last dose date were included, up to 20 days.
Subjects with multiple occurrences in the same category are counted once per category regardless of the number of occurrences.
|
|
Nervous system disorders
Dysgeusia
|
1.9%
1/52 • Number of events 1 • The adverse events with start date on or after the date of treatment during treatment period 1 up to (and including) 7 days after the last dose date were included, up to 20 days.
Subjects with multiple occurrences in the same category are counted once per category regardless of the number of occurrences.
|
0.00%
0/52 • The adverse events with start date on or after the date of treatment during treatment period 1 up to (and including) 7 days after the last dose date were included, up to 20 days.
Subjects with multiple occurrences in the same category are counted once per category regardless of the number of occurrences.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/52 • The adverse events with start date on or after the date of treatment during treatment period 1 up to (and including) 7 days after the last dose date were included, up to 20 days.
Subjects with multiple occurrences in the same category are counted once per category regardless of the number of occurrences.
|
1.9%
1/52 • Number of events 1 • The adverse events with start date on or after the date of treatment during treatment period 1 up to (and including) 7 days after the last dose date were included, up to 20 days.
Subjects with multiple occurrences in the same category are counted once per category regardless of the number of occurrences.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/52 • The adverse events with start date on or after the date of treatment during treatment period 1 up to (and including) 7 days after the last dose date were included, up to 20 days.
Subjects with multiple occurrences in the same category are counted once per category regardless of the number of occurrences.
|
1.9%
1/52 • Number of events 1 • The adverse events with start date on or after the date of treatment during treatment period 1 up to (and including) 7 days after the last dose date were included, up to 20 days.
Subjects with multiple occurrences in the same category are counted once per category regardless of the number of occurrences.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator shall be entitled to publish the results of, or make presentations related to, the Study, provided that any publications or presentations to be made within 2 years after completion of the Study shall require the Sponsor's prior written consent.
- Publication restrictions are in place
Restriction type: OTHER