Trial Outcomes & Findings for A Study to Assess the Efficacy of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) on Exercise-induced Bronchoconstriction in Adults and Adolescents With Asthma (NCT NCT04234464)
NCT ID: NCT04234464
Last Updated: 2022-01-13
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
60 participants
Primary outcome timeframe
Up to 60 minutes post exercise challenge
Results posted on
2022-01-13
Participant Flow
Subjects included in the study were male and female adults and adolescents 12 to 70 years of age with a diagnosis of asthma as defined by the Global Initiative for Asthma (GINA) criteria and EIB as defined by a \>=20% decrease from pre-exercise challenge best FEV₁ observed within 60 minutes after an exercise challenge at both screening visits. The first subject enrolled on 15 January 2020 and the last subject completed the study on 28 August 2020. Subjects were enrolled at 6 US study centers.
The randomized treatment phase started after a 1 to 2 week screening period (Visits 1 and 2). In addition to the 60 subjects randomized, 71 subjects were screened but did not participate (70 screen failures, 1 withdrawal by subject).
Participant milestones
| Measure |
A/B - Treatment With BDA MDI 160/180 Followed by Treatment With Placebo MDI
Subjects randomized to receive a single dose of BDA MDI (PT027) at Visit 3/Period 1, and a single dose of placebo MDI at Visit 4/Period 2.
Visit 3/Period 1 (Day 1) - Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol single dose.
Visit 4/Period 2 (Day 8 +/- 6 days) - Placebo metered-dose inhaler: Placebo inhalation aerosol single dose.
|
B/A - Treatment With Placebo MDI Followed by Treatment With BDA MDI 160/180
Subjects randomized to receive a single dose of placebo MDI at Visit 3/Period 1, and a single dose of BDA MDI (PT027) at Visit 4/Period 2.
Visit 3/Period 1 (Day 1) - Placebo metered-dose inhaler: Placebo inhalation aerosol single dose.
Visit 4/Period 2 (Day 8 +/- 6 days) - Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol single dose.
|
|---|---|---|
|
Period 1 (First Treatment Intervention)
STARTED
|
29
|
31
|
|
Period 1 (First Treatment Intervention)
COMPLETED
|
29
|
31
|
|
Period 1 (First Treatment Intervention)
NOT COMPLETED
|
0
|
0
|
|
Period 2 (Second Treatment Intervention)
STARTED
|
29
|
31
|
|
Period 2 (Second Treatment Intervention)
COMPLETED
|
28
|
31
|
|
Period 2 (Second Treatment Intervention)
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
A/B - Treatment With BDA MDI 160/180 Followed by Treatment With Placebo MDI
Subjects randomized to receive a single dose of BDA MDI (PT027) at Visit 3/Period 1, and a single dose of placebo MDI at Visit 4/Period 2.
Visit 3/Period 1 (Day 1) - Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol single dose.
Visit 4/Period 2 (Day 8 +/- 6 days) - Placebo metered-dose inhaler: Placebo inhalation aerosol single dose.
|
B/A - Treatment With Placebo MDI Followed by Treatment With BDA MDI 160/180
Subjects randomized to receive a single dose of placebo MDI at Visit 3/Period 1, and a single dose of BDA MDI (PT027) at Visit 4/Period 2.
Visit 3/Period 1 (Day 1) - Placebo metered-dose inhaler: Placebo inhalation aerosol single dose.
Visit 4/Period 2 (Day 8 +/- 6 days) - Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol single dose.
|
|---|---|---|
|
Period 2 (Second Treatment Intervention)
Subject did not meet the pre-dose FEV₁ criterion of >70% predicted at Visit 4/Visit 4 repeat.
|
1
|
0
|
Baseline Characteristics
A Study to Assess the Efficacy of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) on Exercise-induced Bronchoconstriction in Adults and Adolescents With Asthma
Baseline characteristics by cohort
| Measure |
A/B - Treatment With BDA MDI 160/180 Followed by Treatment With Placebo MDI
n=29 Participants
Subjects randomized to receive single dose of BDA MDI (PT027) at Visit 3/Period 1, and a single dose of placebo MDI at Visit 4/Period 2.
Visit 3/Period 1 (Day 1) - Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol single dose
Visit 4/Period 2 (Day 8 +/- 6 days) - Placebo metered-dose inhaler: Placebo inhalation aerosol single dose
|
B/A - Treatment With Placebo MDI Followed by Treatment With BDA MDI 160/180
n=31 Participants
Subjects randomized to receive single dose of placebo MDI at Visit 3/Period 1, and a single dose of BDA MDI (PT027) at Visit 4/Period 2.
Visit 3/Period 1 (Day 1) - Placebo metered-dose inhaler: Placebo inhalation aerosol single dose
Visit 4/Period 2 (Day 8 +/- 6 days) - Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol single dose
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
39.1 years
STANDARD_DEVIATION 12.28 • n=5 Participants
|
41.8 years
STANDARD_DEVIATION 11.31 • n=7 Participants
|
40.5 years
STANDARD_DEVIATION 11.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
31 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Height
|
167.0 Centimeters
STANDARD_DEVIATION 9.41 • n=5 Participants
|
170.7 Centimeters
STANDARD_DEVIATION 10.28 • n=7 Participants
|
168.9 Centimeters
STANDARD_DEVIATION 9.96 • n=5 Participants
|
|
Weight
|
81.3 Kilograms
STANDARD_DEVIATION 18.50 • n=5 Participants
|
84.4 Kilograms
STANDARD_DEVIATION 21.60 • n=7 Participants
|
82.9 Kilograms
STANDARD_DEVIATION 20.05 • n=5 Participants
|
|
Body Mass Index
|
29.0 Kilograms per meter squared
STANDARD_DEVIATION 5.51 • n=5 Participants
|
28.7 Kilograms per meter squared
STANDARD_DEVIATION 5.52 • n=7 Participants
|
28.8 Kilograms per meter squared
STANDARD_DEVIATION 5.47 • n=5 Participants
|
|
Maximal Heart Rate at Screening Visit 1
|
167.2 Beats per minute
STANDARD_DEVIATION 15.11 • n=5 Participants
|
164.1 Beats per minute
STANDARD_DEVIATION 12.71 • n=7 Participants
|
165.6 Beats per minute
STANDARD_DEVIATION 13.90 • n=5 Participants
|
|
Maximal Heart Rate at Screening Visit 2
|
166.3 Beats per minute
STANDARD_DEVIATION 15.83 • n=5 Participants
|
163.3 Beats per minute
STANDARD_DEVIATION 12.88 • n=7 Participants
|
164.8 Beats per minute
STANDARD_DEVIATION 14.34 • n=5 Participants
|
|
Pre-dose pre-ECT FEV₁
|
2.712 Liters
STANDARD_DEVIATION 0.5895 • n=5 Participants
|
2.608 Liters
STANDARD_DEVIATION 0.6409 • n=7 Participants
|
2.658 Liters
STANDARD_DEVIATION 0.6137 • n=5 Participants
|
|
Pre-dose pre-ECT FEV₁ % predicted normal
|
84.86 Percentage of predicted normal
STANDARD_DEVIATION 12.914 • n=5 Participants
|
78.24 Percentage of predicted normal
STANDARD_DEVIATION 6.567 • n=7 Participants
|
81.44 Percentage of predicted normal
STANDARD_DEVIATION 10.593 • n=5 Participants
|
|
Pre-dose pre-ECT FVC
|
3.823 Liters
STANDARD_DEVIATION 0.9770 • n=5 Participants
|
3.546 Liters
STANDARD_DEVIATION 1.0576 • n=7 Participants
|
3.680 Liters
STANDARD_DEVIATION 1.0204 • n=5 Participants
|
|
Pre-dose pre-ECT FEV₁/FVC
|
71.88 Percent
STANDARD_DEVIATION 8.143 • n=5 Participants
|
74.97 Percent
STANDARD_DEVIATION 9.051 • n=7 Participants
|
73.47 Percent
STANDARD_DEVIATION 8.692 • n=5 Participants
|
|
Time since diagnosis of asthma to randomization
|
25.19 years
n=5 Participants
|
28.59 years
n=7 Participants
|
27.36 years
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 60 minutes post exercise challengeLung 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
| Measure |
Treatment Intervention A - BDA MDI 160/180 - All Subjects
n=60 Participants
Analysis of subjects receiving Treatment Intervention A - BDA MDI 160/180
|
Treatment Intervention B - Placebo MDI - All Subjects
n=59 Participants
Analysis of subjects receiving Treatment Intervention B - Placebo MDI
|
|---|---|---|
|
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
|
5.45 Maximum percentage fall FEV₁
Interval 2.56 to 8.35
|
18.97 Maximum percentage fall FEV₁
Interval 16.06 to 21.88
|
SECONDARY outcome
Timeframe: Up to 60 minutes post exercise challengeThe 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% was determined.
Outcome measures
| Measure |
Treatment Intervention A - BDA MDI 160/180 - All Subjects
n=60 Participants
Analysis of subjects receiving Treatment Intervention A - BDA MDI 160/180
|
Treatment Intervention B - Placebo MDI - All Subjects
n=60 Participants
Analysis of subjects receiving Treatment Intervention B - Placebo MDI
|
|---|---|---|
|
Percentage of Subjects With a Maximum Percentage Fall in FEV₁ Post-exercise Challenge of <10%
|
47 Participants
|
17 Participants
|
Adverse Events
Treatment Intervention - BDA MDI 160/180 - All Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment Intervention - Placebo MDI - All Subjects
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 Intervention - BDA MDI 160/180 - All Subjects
n=60 participants at risk
Safety analysis of subjects receiving Treatment A - BDA MDI 160/180
|
Treatment Intervention - Placebo MDI - All Subjects
n=59 participants at risk
Safety analysis of subjects receiving Treatment B - Placebo MDI
|
|---|---|---|
|
Psychiatric disorders
Anxiety
|
0.00%
0/60 • Approximately one week for each treatment intervention.
Safety population included all subjects who received at least one treatment intervention.
|
1.7%
1/59 • Number of events 1 • Approximately one week for each treatment intervention.
Safety population included all subjects who received at least one treatment intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/60 • Approximately one week for each treatment intervention.
Safety population included all subjects who received at least one treatment intervention.
|
1.7%
1/59 • Number of events 1 • Approximately one week for each treatment intervention.
Safety population included all subjects who received at least one treatment intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Data or results obtained from this study must not be published without prior approval from the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER