Trial Outcomes & Findings for A Study to Investigate the Effects of PT027 (Budesonide/Albuterol Sulfate) Metered-dose Inhaler Compared With Placebo on Exercise-Induced Bronchoconstriction in Adult Patients With Asthma (NCT NCT06245551)

Results Overview

Lung function was measured by spirometry. Spirometry assessments were completed 5 minutes before dosing, 30 minutes after dosing (baseline; 5 minutes before the exercise challenge), and then 5, 10, 15, 30, and 60 minutes after the exercise challenge. A reduction in FEV₁ was expected due to the effects of asthma and exercise on breathing and lung function. The percentage fall in FEV₁ was calculated based on the baseline value and maximum percentage fall value during the 60-minute assessment period.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

64 participants

Primary outcome timeframe

Up to 60 minutes post-exercise challenge

Results posted on

2025-08-27

Participant Flow

Participant milestones

Participant milestones
Measure	Budesonide/Albuterol Metered-dose Inhaler (BDA MDI) 160/180 - Placebo Participants administered BDA MDI 160/180 during 1st period and placebo in 2nd period	Placebo - Budesonide/Albuterol Metered-dose Inhaler (BDA MDI) 160/180 Participants administered placebo during 1st period and BDA MDI 160/180 in 2nd period
Overall Study STARTED	31	33
Overall Study COMPLETED	31	33
Overall Study NOT COMPLETED	0	0
1st Period STARTED	31	33
1st Period COMPLETED	31	33
1st Period NOT COMPLETED	0	0
2nd Period STARTED	31	33
2nd Period COMPLETED	31	33
2nd Period NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Investigate the Effects of PT027 (Budesonide/Albuterol Sulfate) Metered-dose Inhaler Compared With Placebo on Exercise-Induced Bronchoconstriction in Adult Patients With Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Budesonide/Albuterol Metered-dose Inhaler (BDA MDI) 160/180 - Placebo n=31 Participants Participants administered BDA MDI 160/180 during 1st period and placebo in 2nd period	Placebo - Budesonide/Albuterol Metered-dose Inhaler (BDA MDI) 160/180 n=33 Participants Participants administered placebo during 1st period and BDA MDI 160/180 in 2nd period	Total n=64 Participants Total of all reporting groups
Age, Continuous	39.0 years STANDARD_DEVIATION 14.5 • n=93 Participants	43.2 years STANDARD_DEVIATION 13.9 • n=4 Participants	41.1 years STANDARD_DEVIATION 14.2 • n=27 Participants
Age, Customized < 65 years	30 Participants n=93 Participants	32 Participants n=4 Participants	62 Participants n=27 Participants
Age, Customized >= 65 years	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Sex: Female, Male Female	19 Participants n=93 Participants	17 Participants n=4 Participants	36 Participants n=27 Participants
Sex: Female, Male Male	12 Participants n=93 Participants	16 Participants n=4 Participants	28 Participants n=27 Participants
Race/Ethnicity, Customized White	31 Participants n=93 Participants	33 Participants n=4 Participants	64 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	31 Participants n=93 Participants	32 Participants n=4 Participants	63 Participants n=27 Participants
Race/Ethnicity, Customized Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Pre-dose pre-exercise challenge test (ECT) forced expiratory volume in 1 second (FEV1)	2.925 liters STANDARD_DEVIATION 0.826 • n=93 Participants	3.042 liters STANDARD_DEVIATION 0.877 • n=4 Participants	2.985 liters STANDARD_DEVIATION 0.848 • n=27 Participants

PRIMARY outcome

Timeframe: Up to 60 minutes post-exercise challenge

Population: Full analysis set

Lung function was measured by spirometry. Spirometry assessments were completed 5 minutes before dosing, 30 minutes after dosing (baseline; 5 minutes before the exercise challenge), and then 5, 10, 15, 30, and 60 minutes after the exercise challenge. A reduction in FEV₁ was expected due to the effects of asthma and exercise on breathing and lung function. The percentage fall in FEV₁ was calculated based on the baseline value and maximum percentage fall value during the 60-minute assessment period.

Outcome measures

Outcome measures
Measure	BDA MDI 160/180 n=64 Participants Participants administered BDA MDI 160/180 during 1st or 2nd period	Placebo n=64 Participants Participants administered placebo during 1st or 2nd period
Maximum Percentage Fall From Post-dose, Pre-exercise Baseline in Forced Expiratory Volume in 1 Second (FEV₁) Observed up to 60 Minutes Post-exercise Challenge All subjects	6.95 Percent fall Interval 5.36 to 8.54	24.46 Percent fall Interval 22.87 to 26.05
Maximum Percentage Fall From Post-dose, Pre-exercise Baseline in Forced Expiratory Volume in 1 Second (FEV₁) Observed up to 60 Minutes Post-exercise Challenge Non-ICS	6.28 Percent fall Interval 3.63 to 8.93	26.62 Percent fall Interval 23.97 to 29.28
Maximum Percentage Fall From Post-dose, Pre-exercise Baseline in Forced Expiratory Volume in 1 Second (FEV₁) Observed up to 60 Minutes Post-exercise Challenge ICS	7.29 Percent fall Interval 5.32 to 9.25	23.28 Percent fall Interval 21.32 to 25.25

SECONDARY outcome

Timeframe: Up to 60 minutes post exercise challenge

The percentage fall in FEV₁ was calculated based on the baseline value and maximum percentage fall value during the 60-minute assessment period, and the percentage of subjects with a maximum percentage fall \<10% and \<20% was determined

Outcome measures

Outcome measures
Measure	BDA MDI 160/180 n=64 Participants Participants administered BDA MDI 160/180 during 1st or 2nd period	Placebo n=64 Participants Participants administered placebo during 1st or 2nd period
Percentage of Subjects With a Maximum Percentage Fall in FEV₁ Post-exercise Challenge of <10% and <20% Maximum percentage fall <10%	48 Participants	2 Participants
Percentage of Subjects With a Maximum Percentage Fall in FEV₁ Post-exercise Challenge of <10% and <20% Maximum percentage fall <20%	62 Participants	14 Participants

SECONDARY outcome

Timeframe: Up to 60 minutes post exercise challenge

The percentage fall in FEV₁ at each time point was calculated based on the baseline value and percentage fall value during the 60-minute assessment period at each time point.

Outcome measures

Outcome measures
Measure	BDA MDI 160/180 n=64 Participants Participants administered BDA MDI 160/180 during 1st or 2nd period	Placebo n=64 Participants Participants administered placebo during 1st or 2nd period
Percentage Fall From Post-dose, Pre-exercise Baseline in FEV1 at Each Time Point Within 60 Minutes Post-exercise Challenge 5 min Post-ECT	1.68 Percent Interval -0.11 to 3.47	9.79 Percent Interval 8.0 to 11.58
Percentage Fall From Post-dose, Pre-exercise Baseline in FEV1 at Each Time Point Within 60 Minutes Post-exercise Challenge 10 min Post-ECT	3.16 Percent Interval 1.3 to 5.02	17.98 Percent Interval 16.12 to 19.84
Percentage Fall From Post-dose, Pre-exercise Baseline in FEV1 at Each Time Point Within 60 Minutes Post-exercise Challenge 15 min Post-ECT	4.20 Percent Interval 2.38 to 6.03	19.14 Percent Interval 17.31 to 20.97
Percentage Fall From Post-dose, Pre-exercise Baseline in FEV1 at Each Time Point Within 60 Minutes Post-exercise Challenge 30 min Post-ECT	2.64 Percent Interval 0.65 to 4.63	11.85 Percent Interval 9.87 to 13.84
Percentage Fall From Post-dose, Pre-exercise Baseline in FEV1 at Each Time Point Within 60 Minutes Post-exercise Challenge 60 min Post-ECT	0.56 Percent Interval -0.83 to 1.94	3.10 Percent Interval 1.72 to 4.48

SECONDARY outcome

Timeframe: Up to 30 minutes post exercise challenge

FEV1 AUC0-30min will be derived for the changes from the post-dose, pre-exercise baseline using the trapezoidal rule and will be normalized by dividing by the actual time (in minutes) from dosing to the last included measurement, scheduled at 30 minutes post-exercise challenge.

Outcome measures

Outcome measures
Measure	BDA MDI 160/180 n=64 Participants Participants administered BDA MDI 160/180 during 1st or 2nd period	Placebo n=64 Participants Participants administered placebo during 1st or 2nd period
Post-Exercise FEV1 Area Under the Curve From 0 to 30 Minutes (AUC0-30min)	-0.10 liter Standard Deviation 0.16	-0.44 liter Standard Deviation 0.23

SECONDARY outcome

Timeframe: Up to 60 minutes post exercise challenge

Time to recovery will be derived as the time (minutes) post-exercise challenge in which the FEV1 result returns to within 10% of the value recorded at the post-dose, pre-exercise baseline.

Outcome measures

Outcome measures
Measure	BDA MDI 160/180 n=64 Participants Participants administered BDA MDI 160/180 during 1st or 2nd period	Placebo n=64 Participants Participants administered placebo during 1st or 2nd period
Time To Recovery	56 Participants	6 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, an average of 4 weeks

The safety profile will be evaluated using vital signs, physical examination, electrocardiograms (ECGs) and AE data.

Outcome measures

Outcome measures
Measure	BDA MDI 160/180 n=64 Participants Participants administered BDA MDI 160/180 during 1st or 2nd period	Placebo n=64 Participants Participants administered placebo during 1st or 2nd period
Number of Participants With Adverse Events (AEs)	1 Participants	2 Participants

Adverse Events

BDA MDI 160/180

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	BDA MDI 160/180 n=64 participants at risk Participants administered BDA MDI 160/180 during 1st or 2nd period	Placebo n=64 participants at risk Participants administered placebo during 1st or 2nd period
Gastrointestinal disorders Diarrhoea	0.00% 0/64 • Adverse events presented in the tables below were collected during up to 19 days from the time of first study treatment to follow-up telephone call. Actual time for each participant depends on duration of their participation in the study.	1.6% 1/64 • Number of events 1 • Adverse events presented in the tables below were collected during up to 19 days from the time of first study treatment to follow-up telephone call. Actual time for each participant depends on duration of their participation in the study.
Nervous system disorders Headache	0.00% 0/64 • Adverse events presented in the tables below were collected during up to 19 days from the time of first study treatment to follow-up telephone call. Actual time for each participant depends on duration of their participation in the study.	1.6% 1/64 • Number of events 1 • Adverse events presented in the tables below were collected during up to 19 days from the time of first study treatment to follow-up telephone call. Actual time for each participant depends on duration of their participation in the study.
Respiratory, thoracic and mediastinal disorders Bronchial irritation	1.6% 1/64 • Number of events 1 • Adverse events presented in the tables below were collected during up to 19 days from the time of first study treatment to follow-up telephone call. Actual time for each participant depends on duration of their participation in the study.	0.00% 0/64 • Adverse events presented in the tables below were collected during up to 19 days from the time of first study treatment to follow-up telephone call. Actual time for each participant depends on duration of their participation in the study.

Additional Information

Global Clinical Lead

AstraZeneca

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place