Trial Outcomes & Findings for A Study Evaluating the Effect of Inhaled PT007(AS MDI) Versus Placebo MDI and Ventolin Evohaler on Lung Function in Adult Participants With Asthma (NCT NCT06644924)
NCT ID: NCT06644924
Last Updated: 2026-08-27
Results Overview
Change from baseline FEV1 measured at each time point for AS MDI and Ventolin Evohaler. Baseline FEV1 is the period specific mean of the available pre-dose values. Area Under the Curve (AUC) 0-6 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., \~ 6 hours).
COMPLETED
PHASE2
118 participants
0 to 6 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose)
2026-08-27
Participant Flow
This study was conducted at 23 sites in the United States, from February 2025 to May 2025. The study was anticipated to run for at least 15 days but not to exceed 52 days.
A total of 164 subjects were screened for the study of which 118 subjects were randomized and treated with one of the 6 treatment sequences. Each sequence comprised all 3 treatments included in this study (i.e., AS MDI 180 μg, Ventolin Evohaler 200 μg, Placebo) in a randomized order. Remaining 46 subjects were not randomized either due to failure to meet randomization criteria, adverse event, not meeting the eligibility criteria at visit 2 or withdrawal from the study.
Participant milestones
| Measure |
Treatment Sequence 1 - Ventolin Evohaler 200 μg | Placebo | AS MDI 180 μg
Participants received a single dose of Ventolin Evohaler at Visit 2, followed by a single dose of Placebo at Visit 3, and a single dose of AS MDI at Visit 4.
|
Treatment Sequence 2 - AS MDI 180 μg | Ventolin Evohaler 200 μg | Placebo
Participants received a single dose of AS MDI at Visit 2, followed by a single dose of Ventolin Evohaler at Visit 3, and a single dose of Placebo at Visit 4.
|
Treatment Sequence 3 - Placebo | AS MDI 180 μg | Ventolin Evohaler 200 μg
Participants received a single dose of Placebo at Visit 2, followed by a single dose of AS MDI at Visit 3, and a single dose of Ventolin Evohaler at Visit 4.
|
Treatment Sequence 4 - AS MDI 180 μg | Placebo | Ventolin Evohaler 200 μg
Participants received a single dose of AS MDI at Visit 2, followed by a single dose of Placebo at Visit 3, and a single dose of Ventolin Evohaler at Visit 4.
|
Treatment Sequence 5 - Placebo | Ventolin Evohaler 200 μg | AS MDI 180 μg
Participants received a single dose of Placebo at Visit 2, followed by a single dose of Ventolin Evohaler at Visit 3, and a single dose of AS MDI at Visit 4.
|
Treatment Sequence 6 - Ventolin Evohaler 200 μg | AS MDI 180 μg | Placebo
Participants received a single dose of Ventolin Evohaler at Visit 2, followed by a single dose of AS MDI at Visit 3, and a single dose of Placebo at Visit 4.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
20
|
19
|
19
|
19
|
21
|
20
|
|
Treatment Period 1
COMPLETED
|
20
|
18
|
18
|
18
|
18
|
19
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
1
|
1
|
1
|
3
|
1
|
|
Treatment Period 2
STARTED
|
20
|
18
|
18
|
18
|
18
|
19
|
|
Treatment Period 2
COMPLETED
|
20
|
18
|
17
|
17
|
18
|
18
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
1
|
1
|
0
|
1
|
|
Treatment Period 3
STARTED
|
20
|
18
|
17
|
17
|
18
|
18
|
|
Treatment Period 3
COMPLETED
|
20
|
18
|
17
|
17
|
18
|
18
|
|
Treatment Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment Sequence 1 - Ventolin Evohaler 200 μg | Placebo | AS MDI 180 μg
Participants received a single dose of Ventolin Evohaler at Visit 2, followed by a single dose of Placebo at Visit 3, and a single dose of AS MDI at Visit 4.
|
Treatment Sequence 2 - AS MDI 180 μg | Ventolin Evohaler 200 μg | Placebo
Participants received a single dose of AS MDI at Visit 2, followed by a single dose of Ventolin Evohaler at Visit 3, and a single dose of Placebo at Visit 4.
|
Treatment Sequence 3 - Placebo | AS MDI 180 μg | Ventolin Evohaler 200 μg
Participants received a single dose of Placebo at Visit 2, followed by a single dose of AS MDI at Visit 3, and a single dose of Ventolin Evohaler at Visit 4.
|
Treatment Sequence 4 - AS MDI 180 μg | Placebo | Ventolin Evohaler 200 μg
Participants received a single dose of AS MDI at Visit 2, followed by a single dose of Placebo at Visit 3, and a single dose of Ventolin Evohaler at Visit 4.
|
Treatment Sequence 5 - Placebo | Ventolin Evohaler 200 μg | AS MDI 180 μg
Participants received a single dose of Placebo at Visit 2, followed by a single dose of Ventolin Evohaler at Visit 3, and a single dose of AS MDI at Visit 4.
|
Treatment Sequence 6 - Ventolin Evohaler 200 μg | AS MDI 180 μg | Placebo
Participants received a single dose of Ventolin Evohaler at Visit 2, followed by a single dose of AS MDI at Visit 3, and a single dose of Placebo at Visit 4.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1
The subject left town for a job out of town and would not be able to attend study visits.
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Period 1
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Treatment Period 1
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Treatment Period 1
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Treatment Period 1
Protocol Violation
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Treatment Period 2
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Treatment Period 2
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period 2
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Participants in the FAS excluding data for one subject from all lung function analysis due to spirometry performed at submaximal capacity.
Baseline characteristics by cohort
| Measure |
Treatment Sequence 1 - Ventolin Evohaler 200 μg | Placebo | AS MDI 180 μg
n=20 Participants
Participants received a single dose of Ventolin Evohaler at Visit 2, followed by a single dose of Placebo at Visit 3, and a single dose of AS MDI at Visit 4.
|
Treatment Sequence 2 - AS MDI 180 μg | Ventolin Evohaler 200 μg | Placebo
n=19 Participants
Participants received a single dose of AS MDI at Visit 2, followed by a single dose of Ventolin Evohaler at Visit 3, and a single dose of Placebo at Visit 4.
|
Treatment Sequence 3 - Placebo | AS MDI 180 μg | Ventolin Evohaler 200 μg
n=19 Participants
Participants received a single dose of Placebo at Visit 2, followed by a single dose of AS MDI at Visit 3, and a single dose of Ventolin Evohaler at Visit 4.
|
Treatment Sequence 4 - AS MDI 180 μg | Placebo | Ventolin Evohaler 200 μg
n=19 Participants
Participants received a single dose of AS MDI at Visit 2, followed by a single dose of Placebo at Visit 3, and a single dose of Ventolin Evohaler at Visit 4.
|
Treatment Sequence 5 - Placebo | Ventolin Evohaler 200 μg | AS MDI 180 μg
n=21 Participants
Participants received a single dose of Placebo at Visit 2, followed by a single dose of Ventolin Evohaler at Visit 3, and a single dose of AS MDI at Visit 4.
|
Treatment Sequence 6 - Ventolin Evohaler 200 μg | AS MDI 180 μg | Placebo
n=20 Participants
Participants received a single dose of Ventolin Evohaler at Visit 2, followed by a single dose of AS MDI at Visit 3, and a single dose of Placebo at Visit 4.
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
Race · American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=118 Participants
|
|
Race (NIH/OMB)
Race · Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=118 Participants
|
|
Age, Continuous
Age (years)
|
41.7 Years
STANDARD_DEVIATION 11.6 • n=20 Participants
|
44.4 Years
STANDARD_DEVIATION 13.8 • n=19 Participants
|
43.3 Years
STANDARD_DEVIATION 11.7 • n=19 Participants
|
44.6 Years
STANDARD_DEVIATION 12.5 • n=19 Participants
|
41.0 Years
STANDARD_DEVIATION 13.2 • n=21 Participants
|
47.1 Years
STANDARD_DEVIATION 12.9 • n=20 Participants
|
43.6 Years
STANDARD_DEVIATION 12.5 • n=118 Participants
|
|
Sex: Female, Male
Sex · Female
|
9 Participants
n=20 Participants
|
10 Participants
n=19 Participants
|
10 Participants
n=19 Participants
|
10 Participants
n=19 Participants
|
12 Participants
n=21 Participants
|
13 Participants
n=20 Participants
|
64 Participants
n=118 Participants
|
|
Sex: Female, Male
Sex · Male
|
11 Participants
n=20 Participants
|
9 Participants
n=19 Participants
|
9 Participants
n=19 Participants
|
9 Participants
n=19 Participants
|
9 Participants
n=21 Participants
|
7 Participants
n=20 Participants
|
54 Participants
n=118 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity · Hispanic or Latino
|
8 Participants
n=20 Participants
|
4 Participants
n=19 Participants
|
8 Participants
n=19 Participants
|
9 Participants
n=19 Participants
|
8 Participants
n=21 Participants
|
10 Participants
n=20 Participants
|
47 Participants
n=118 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity · Not Hispanic or Latino
|
12 Participants
n=20 Participants
|
15 Participants
n=19 Participants
|
11 Participants
n=19 Participants
|
10 Participants
n=19 Participants
|
13 Participants
n=21 Participants
|
10 Participants
n=20 Participants
|
71 Participants
n=118 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity · Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=118 Participants
|
|
Race (NIH/OMB)
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=118 Participants
|
|
Race (NIH/OMB)
Race · Black or African American
|
3 Participants
n=20 Participants
|
8 Participants
n=19 Participants
|
6 Participants
n=19 Participants
|
4 Participants
n=19 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=20 Participants
|
32 Participants
n=118 Participants
|
|
Race (NIH/OMB)
Race · White
|
16 Participants
n=20 Participants
|
9 Participants
n=19 Participants
|
11 Participants
n=19 Participants
|
14 Participants
n=19 Participants
|
14 Participants
n=21 Participants
|
13 Participants
n=20 Participants
|
77 Participants
n=118 Participants
|
|
Race (NIH/OMB)
Race · More than one race
|
1 Participants
n=20 Participants
|
2 Participants
n=19 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=20 Participants
|
7 Participants
n=118 Participants
|
|
Race (NIH/OMB)
Race · Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=19 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=118 Participants
|
|
Lung function data at screening
Pre-bronchodilator FEV1 (mL)
|
2489.5 FEV1 (mL)
STANDARD_DEVIATION 740.4 • n=19 Participants • Participants in the FAS excluding data for one subject from all lung function analysis due to spirometry performed at submaximal capacity.
|
2261.6 FEV1 (mL)
STANDARD_DEVIATION 824.9 • n=19 Participants • Participants in the FAS excluding data for one subject from all lung function analysis due to spirometry performed at submaximal capacity.
|
2183.2 FEV1 (mL)
STANDARD_DEVIATION 583.4 • n=19 Participants • Participants in the FAS excluding data for one subject from all lung function analysis due to spirometry performed at submaximal capacity.
|
2233.7 FEV1 (mL)
STANDARD_DEVIATION 627.4 • n=19 Participants • Participants in the FAS excluding data for one subject from all lung function analysis due to spirometry performed at submaximal capacity.
|
2201.9 FEV1 (mL)
STANDARD_DEVIATION 682.9 • n=21 Participants • Participants in the FAS excluding data for one subject from all lung function analysis due to spirometry performed at submaximal capacity.
|
2008.0 FEV1 (mL)
STANDARD_DEVIATION 571.9 • n=20 Participants • Participants in the FAS excluding data for one subject from all lung function analysis due to spirometry performed at submaximal capacity.
|
2227.3 FEV1 (mL)
STANDARD_DEVIATION 677.3 • n=117 Participants • Participants in the FAS excluding data for one subject from all lung function analysis due to spirometry performed at submaximal capacity.
|
|
Lung function data at screening
Post-bronchodilator FEV1 (mL)
|
3057.4 FEV1 (mL)
STANDARD_DEVIATION 800.5 • n=19 Participants • Participants in the FAS excluding data for one subject from all lung function analysis due to spirometry performed at submaximal capacity.
|
2851.6 FEV1 (mL)
STANDARD_DEVIATION 792.2 • n=19 Participants • Participants in the FAS excluding data for one subject from all lung function analysis due to spirometry performed at submaximal capacity.
|
2715.8 FEV1 (mL)
STANDARD_DEVIATION 573.9 • n=19 Participants • Participants in the FAS excluding data for one subject from all lung function analysis due to spirometry performed at submaximal capacity.
|
2830.0 FEV1 (mL)
STANDARD_DEVIATION 702.0 • n=19 Participants • Participants in the FAS excluding data for one subject from all lung function analysis due to spirometry performed at submaximal capacity.
|
2741.0 FEV1 (mL)
STANDARD_DEVIATION 755.2 • n=21 Participants • Participants in the FAS excluding data for one subject from all lung function analysis due to spirometry performed at submaximal capacity.
|
2582.0 FEV1 (mL)
STANDARD_DEVIATION 677.4 • n=20 Participants • Participants in the FAS excluding data for one subject from all lung function analysis due to spirometry performed at submaximal capacity.
|
2793.5 FEV1 (mL)
STANDARD_DEVIATION 720.6 • n=117 Participants • Participants in the FAS excluding data for one subject from all lung function analysis due to spirometry performed at submaximal capacity.
|
|
Bronchodilator responsiveness at screening
|
16.4 %
STANDARD_DEVIATION 3.8 • n=19 Participants • Participants in the FAS excluding data for one subject from all lung function analysis due to spirometry performed at submaximal capacity.
|
18.8 %
STANDARD_DEVIATION 6.4 • n=19 Participants • Participants in the FAS excluding data for one subject from all lung function analysis due to spirometry performed at submaximal capacity.
|
16.4 %
STANDARD_DEVIATION 6.4 • n=19 Participants • Participants in the FAS excluding data for one subject from all lung function analysis due to spirometry performed at submaximal capacity.
|
18.6 %
STANDARD_DEVIATION 6.8 • n=19 Participants • Participants in the FAS excluding data for one subject from all lung function analysis due to spirometry performed at submaximal capacity.
|
15.6 %
STANDARD_DEVIATION 3.0 • n=21 Participants • Participants in the FAS excluding data for one subject from all lung function analysis due to spirometry performed at submaximal capacity.
|
18.7 %
STANDARD_DEVIATION 9.5 • n=20 Participants • Participants in the FAS excluding data for one subject from all lung function analysis due to spirometry performed at submaximal capacity.
|
17.4 %
STANDARD_DEVIATION 6.3 • n=117 Participants • Participants in the FAS excluding data for one subject from all lung function analysis due to spirometry performed at submaximal capacity.
|
PRIMARY outcome
Timeframe: 0 to 6 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose)Population: Participants who in the Full Analysis Set (FAS), have completed AS MDI and Ventolin Evohaler doses without any Intercurrent Events (ICE) on or before Day 1 of the corresponding AS MDI and Ventolin Evohaler periods, and have AS MDI and Ventolin Evohaler Day 1's pre-dose FEV1 value, at least one FEV1 value post dose 0-3 hours, and at least one FEV1 value post dose 3-6 hours. Participants were analysed according to the actual intervention received.
Change from baseline FEV1 measured at each time point for AS MDI and Ventolin Evohaler. Baseline FEV1 is the period specific mean of the available pre-dose values. Area Under the Curve (AUC) 0-6 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., \~ 6 hours).
Outcome measures
| Measure |
AS MDI 180 μg
n=108 Participants
Participants received a single dose (2 actuation of 90 microgram) AS MDI at either of the 3 visits irrespective of the treatment sequence.
|
Ventolin Evohaler 200 μg
n=108 Participants
Participants received a single dose (2 actuations of 100 μg) of Ventolin Evohaler at either of the 3 visits irrespective of the treatment sequence.
|
|---|---|---|
|
Change From Baseline in FEV1 AUC 0-6 Hours (mL) for AS MDI Relative to Ventolin Evohaler - Non-inferiority Analysis
|
186.77 milliliters (mL)
Interval 146.73 to 226.81
|
207.33 milliliters (mL)
Interval 167.29 to 247.38
|
PRIMARY outcome
Timeframe: 0 to 6 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose)Population: Participants who in the FAS, have completed Ventolin Evohaler and Placebo doses without any ICEs on or before Day 1 of the corresponding Ventolin Evohaler and Placebo periods, and have Ventolin Evohaler and Placebo Day 1's pre-dose FEV1 value, at least one FEV1 value post dose 0-3 hours, and at least one FEV1 value post dose 3-6 hours. Participants were analysed according to the actual intervention received.
Change from baseline in FEV1 measured at each time point for Ventolin Evohaler and Placebo. Baseline FEV1 is the period specific mean of the available pre-dose values. AUC 0-6 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., \~ 6 hours).
Outcome measures
| Measure |
AS MDI 180 μg
n=107 Participants
Participants received a single dose (2 actuation of 90 microgram) AS MDI at either of the 3 visits irrespective of the treatment sequence.
|
Ventolin Evohaler 200 μg
n=107 Participants
Participants received a single dose (2 actuations of 100 μg) of Ventolin Evohaler at either of the 3 visits irrespective of the treatment sequence.
|
|---|---|---|
|
Change From Baseline in FEV1 AUC 0-6 Hours (mL) for Ventolin Evohaler Compared With Placebo - Superiority Analysis
|
205.27 milliliters (mL)
Interval 168.61 to 241.92
|
67.84 milliliters (mL)
Interval 31.19 to 104.48
|
SECONDARY outcome
Timeframe: 0 to 6 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose)Population: Participants who in the FAS, have completed AS MDI and Ventolin Evohaler doses without any Intercurrent Events (ICE) on or before Day 1 of the corresponding AS MDI and Ventolin Evohaler periods, and have AS MDI and Ventolin Evohaler Day 1's pre-dose FEV1 value, at least one FEV1 value post dose 0-3 hours, and at least one FEV1 value post dose 3-6 hours. Participants were analysed according to the actual intervention received.
Change from baseline FEV1 measured at each time point for AS MDI and Ventolin Evohaler. Baseline FEV1 is the period specific mean of the available pre-dose values. AUC 0-6 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., \~ 6 hours).
Outcome measures
| Measure |
AS MDI 180 μg
n=108 Participants
Participants received a single dose (2 actuation of 90 microgram) AS MDI at either of the 3 visits irrespective of the treatment sequence.
|
Ventolin Evohaler 200 μg
n=108 Participants
Participants received a single dose (2 actuations of 100 μg) of Ventolin Evohaler at either of the 3 visits irrespective of the treatment sequence.
|
|---|---|---|
|
Change From Baseline in FEV1 AUC 0-6 Hours (mL) for AS MDI Relative to Ventolin Evohaler - Equivalence Analysis
|
186.77 milliliters (mL)
Interval 146.73 to 226.81
|
207.33 milliliters (mL)
Interval 167.29 to 247.38
|
SECONDARY outcome
Timeframe: 0 to 4 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose)Population: Participants who in the FAS, have completed AS MDI and Ventolin Evohaler doses without any ICEs on or before Day 1 of the corresponding AS MDI and Ventolin Evohaler periods, and have AS MDI and Ventolin Evohaler Day 1's pre-dose FEV1 value and at least one FEV1 value post dose 0-4 hours. Participants will be analysed according to the actual intervention received.
Change from baseline FEV1 measured at each time point for AS MDI and Ventolin Evohaler. Baseline FEV1 is the period specific mean of the available pre-dose values. AUC 0-4 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., \~ 4 hours).
Outcome measures
| Measure |
AS MDI 180 μg
n=108 Participants
Participants received a single dose (2 actuation of 90 microgram) AS MDI at either of the 3 visits irrespective of the treatment sequence.
|
Ventolin Evohaler 200 μg
n=108 Participants
Participants received a single dose (2 actuations of 100 μg) of Ventolin Evohaler at either of the 3 visits irrespective of the treatment sequence.
|
|---|---|---|
|
Change From Baseline in FEV1 AUC 0-4 Hours (mL) for AS MDI Relative to Ventolin Evohaler - Non-inferiority Analysis
|
228.32 milliliters (mL)
Interval 186.06 to 270.57
|
248.77 milliliters (mL)
Interval 206.51 to 291.03
|
SECONDARY outcome
Timeframe: 0 to 4 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose)Population: Participants who in the FAS, have completed Ventolin Evohaler and Placebo doses without any ICEs on or before Day 1 of the corresponding Ventolin Evohaler and Placebo periods, and have Ventolin Evohaler and Placebo Day 1's pre-dose FEV1 value and at least one FEV1 value post dose 0-4 hours. Participants will be analysed according to the actual intervention received.
Change from baseline FEV1 measured at each time point for Ventolin Evohaler and Placebo. Baseline FEV1 is the period specific mean of the available pre-dose values. AUC 0-4 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., \~ 4 hours).
Outcome measures
| Measure |
AS MDI 180 μg
n=107 Participants
Participants received a single dose (2 actuation of 90 microgram) AS MDI at either of the 3 visits irrespective of the treatment sequence.
|
Ventolin Evohaler 200 μg
n=107 Participants
Participants received a single dose (2 actuations of 100 μg) of Ventolin Evohaler at either of the 3 visits irrespective of the treatment sequence.
|
|---|---|---|
|
Change From Baseline in FEV1 AUC 0-4 Hours (mL) for Ventolin Evohaler Compared With Placebo - Superiority Analysis
|
246.34 milliliters (mL)
Interval 208.97 to 283.72
|
69.15 milliliters (mL)
Interval 31.78 to 106.52
|
SECONDARY outcome
Timeframe: 0 to 4 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose)Population: Participants who in the FAS, have completed AS MDI and Ventolin Evohaler doses without any ICEs on or before Day 1 of the corresponding AS MDI and Ventolin Evohaler periods, and have AS MDI and Ventolin Evohaler Day 1's pre-dose FEV1 value and at least one FEV1 value post dose 0-4 hours. Participants will be analysed according to the actual intervention received.
Change from baseline FEV1 measured at each time point for AS MDI and Ventolin Evohaler. Baseline FEV1 is the period specific mean of the available pre-dose values. AUC 0-4 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., \~ 4 hours).
Outcome measures
| Measure |
AS MDI 180 μg
n=108 Participants
Participants received a single dose (2 actuation of 90 microgram) AS MDI at either of the 3 visits irrespective of the treatment sequence.
|
Ventolin Evohaler 200 μg
n=108 Participants
Participants received a single dose (2 actuations of 100 μg) of Ventolin Evohaler at either of the 3 visits irrespective of the treatment sequence.
|
|---|---|---|
|
Change From Baseline in FEV1 AUC 0-4 Hours (mL) for AS MDI Relative to Ventolin Evohaler - Equivalence Analysis
|
228.32 milliliters (mL)
Interval 186.06 to 270.57
|
248.77 milliliters (mL)
Interval 206.51 to 291.03
|
SECONDARY outcome
Timeframe: 0 to 6 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose)Population: Participants who in the FAS, have completed AS MDI and Ventolin Evohaler doses without any ICEs on or before Day 1 of the corresponding AS MDI and Ventolin Evohaler periods, have AS MDI and Ventolin Evohaler Day 1's pre-dose FEV1 value, and have at least one FEV1 value post dose 0-6 hours. Participants will be analysed according to the actual intervention received.
Peak change from baseline in FEV1 is the difference between the maximum FEV1 value measured during the 6 hour post dose period and the baseline FEV1 for AS MDI and Ventolin Evohaler. Baseline FEV1 is the period specific mean of the available pre-dose values.
Outcome measures
| Measure |
AS MDI 180 μg
n=108 Participants
Participants received a single dose (2 actuation of 90 microgram) AS MDI at either of the 3 visits irrespective of the treatment sequence.
|
Ventolin Evohaler 200 μg
n=108 Participants
Participants received a single dose (2 actuations of 100 μg) of Ventolin Evohaler at either of the 3 visits irrespective of the treatment sequence.
|
|---|---|---|
|
Peak Change From Baseline in FEV1 (mL) for AS MDI Relative to Ventolin Evohaler - Non-inferiority Analysis
|
384.54 milliliters (mL)
Interval 330.04 to 439.05
|
434.03 milliliters (mL)
Interval 379.51 to 488.54
|
SECONDARY outcome
Timeframe: 0 to 6 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose)Population: Participants who in the FAS, have completed Ventolin Evohaler and Placebo doses without any ICEs on or before Day 1 of the corresponding Ventolin Evohaler and Placebo periods, have Ventolin Evohaler and Placebo Day 1's pre-dose FEV1 value, and have at least one FEV1 value post dose 0-6 hours. Participants will be analysed according to the actual intervention received.
Peak change from baseline in FEV1 is the difference between the maximum FEV1 value measured during the 6 hour post dose period and the baseline FEV1 for Ventolin Evohaler and Placebo. Baseline FEV1 is the period specific mean of the available pre-dose values.
Outcome measures
| Measure |
AS MDI 180 μg
n=107 Participants
Participants received a single dose (2 actuation of 90 microgram) AS MDI at either of the 3 visits irrespective of the treatment sequence.
|
Ventolin Evohaler 200 μg
n=107 Participants
Participants received a single dose (2 actuations of 100 μg) of Ventolin Evohaler at either of the 3 visits irrespective of the treatment sequence.
|
|---|---|---|
|
Peak Change From Baseline in FEV1 (mL) for Ventolin Evohaler Compared With Placebo - Superiority Analysis
|
433.43 milliliters (mL)
Interval 382.76 to 484.1
|
235.59 milliliters (mL)
Interval 184.93 to 286.24
|
SECONDARY outcome
Timeframe: 0 to 6 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose)Population: Participants who in the FAS, have completed AS MDI and Ventolin Evohaler doses without any ICEs on or before Day 1 of the corresponding AS MDI and Ventolin Evohaler periods, have AS MDI and Ventolin Evohaler Day 1's pre-dose FEV1 value, and have at least one FEV1 value post dose 0-6 hours. Participants will be analysed according to the actual intervention received.
Peak change from baseline in FEV1 is the difference between the maximum FEV1 value measured during the 6 hour post dose period and the baseline FEV1 for AS MDI and Ventolin Evohaler. Baseline FEV1 is the period specific mean of the available pre-dose values.
Outcome measures
| Measure |
AS MDI 180 μg
n=108 Participants
Participants received a single dose (2 actuation of 90 microgram) AS MDI at either of the 3 visits irrespective of the treatment sequence.
|
Ventolin Evohaler 200 μg
n=108 Participants
Participants received a single dose (2 actuations of 100 μg) of Ventolin Evohaler at either of the 3 visits irrespective of the treatment sequence.
|
|---|---|---|
|
Peak Change From Baseline in FEV1 (mL) for AS MDI Relative to Ventolin Evohaler - Equivalence Analysis
|
384.54 milliliters (mL)
Interval 330.04 to 439.05
|
434.03 milliliters (mL)
Interval 379.51 to 488.54
|
Adverse Events
AS MDI 180 μg
Ventolin Evohaler 200 μg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AS MDI 180 μg
n=113 participants at risk
Participants received a single dose (2 actuation of 90 μg) AS MDI at either of the 3 visits irrespective of the treatment sequence.
|
Ventolin Evohaler 200 μg
n=110 participants at risk
Participants received a single dose (2 actuations of 100 μg) of Ventolin Evohaler at either of the 3 visits irrespective of the treatment sequence.
|
Placebo
n=114 participants at risk
Participants received a single dose (2 actuations matching AS MDI) of Placebo at either of the 3 visits irrespective of the treatment sequence.
|
|---|---|---|---|
|
Infections and infestations
Acute sinusitis
|
0.88%
1/113 • Number of events 1 • On-treatment Adverse events include adverse events with an onset date on or 1 day after the dose of study intervention. This includes worsening of pre-existing events before randomisation.
Safety set included participants who were randomised to study intervention and received at least one inhalation of the study intervention.
|
0.00%
0/110 • On-treatment Adverse events include adverse events with an onset date on or 1 day after the dose of study intervention. This includes worsening of pre-existing events before randomisation.
Safety set included participants who were randomised to study intervention and received at least one inhalation of the study intervention.
|
0.00%
0/114 • On-treatment Adverse events include adverse events with an onset date on or 1 day after the dose of study intervention. This includes worsening of pre-existing events before randomisation.
Safety set included participants who were randomised to study intervention and received at least one inhalation of the study intervention.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/113 • On-treatment Adverse events include adverse events with an onset date on or 1 day after the dose of study intervention. This includes worsening of pre-existing events before randomisation.
Safety set included participants who were randomised to study intervention and received at least one inhalation of the study intervention.
|
0.00%
0/110 • On-treatment Adverse events include adverse events with an onset date on or 1 day after the dose of study intervention. This includes worsening of pre-existing events before randomisation.
Safety set included participants who were randomised to study intervention and received at least one inhalation of the study intervention.
|
0.88%
1/114 • Number of events 1 • On-treatment Adverse events include adverse events with an onset date on or 1 day after the dose of study intervention. This includes worsening of pre-existing events before randomisation.
Safety set included participants who were randomised to study intervention and received at least one inhalation of the study intervention.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/113 • On-treatment Adverse events include adverse events with an onset date on or 1 day after the dose of study intervention. This includes worsening of pre-existing events before randomisation.
Safety set included participants who were randomised to study intervention and received at least one inhalation of the study intervention.
|
0.91%
1/110 • Number of events 1 • On-treatment Adverse events include adverse events with an onset date on or 1 day after the dose of study intervention. This includes worsening of pre-existing events before randomisation.
Safety set included participants who were randomised to study intervention and received at least one inhalation of the study intervention.
|
0.00%
0/114 • On-treatment Adverse events include adverse events with an onset date on or 1 day after the dose of study intervention. This includes worsening of pre-existing events before randomisation.
Safety set included participants who were randomised to study intervention and received at least one inhalation of the study intervention.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/113 • On-treatment Adverse events include adverse events with an onset date on or 1 day after the dose of study intervention. This includes worsening of pre-existing events before randomisation.
Safety set included participants who were randomised to study intervention and received at least one inhalation of the study intervention.
|
0.91%
1/110 • Number of events 1 • On-treatment Adverse events include adverse events with an onset date on or 1 day after the dose of study intervention. This includes worsening of pre-existing events before randomisation.
Safety set included participants who were randomised to study intervention and received at least one inhalation of the study intervention.
|
0.00%
0/114 • On-treatment Adverse events include adverse events with an onset date on or 1 day after the dose of study intervention. This includes worsening of pre-existing events before randomisation.
Safety set included participants who were randomised to study intervention and received at least one inhalation of the study intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place