Trial Outcomes & Findings for Assessment of the Safety, Efficacy, PK, and Extrapulmonary Pharmacodynamics (PD) of Albuterol Sulfate Pressurized Inhalation Suspension (Hereafter Referred to as AS MDI) Compared to Proventil as an Active Control in Subjects With Asthma (NCT NCT03371459)
NCT ID: NCT03371459
Last Updated: 2019-07-23
Results Overview
Forced expiratory volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
At the two study treatment visits, FEV1 (forced expiratory volume in 1 second) will be measured prior to drug administration and 5 times, once at 30 minutes after each of the 5 doses
Results posted on
2019-07-23
Participant Flow
Subjects who met all screening and randomization requirements were eligible for rand to Tx Period, comprised of Visits 2 and 3 . Eligible subj were rand via IWRS to receive 2 cumulative-dose Tx's in one of 2 possible Tx sequences: AS MDI, given as 1+1+2+4+8 actuations of AS MDI 90 μg, Proventil, given as 1+1+2+4+8 actuations of Proventil 90 μg
Participant milestones
| Measure |
Treatment Sequence A
AS MDI 90 ug then Proventil 90 ug
|
Treatment Sequence B
Proventil 90 ug then AS MDI 90 ug
|
|---|---|---|
|
Period 1
STARTED
|
23
|
23
|
|
Period 1
COMPLETED
|
23
|
23
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Washout
STARTED
|
23
|
23
|
|
Washout
COMPLETED
|
23
|
22
|
|
Washout
NOT COMPLETED
|
0
|
1
|
|
Period 2
STARTED
|
23
|
22
|
|
Period 2
COMPLETED
|
23
|
22
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment Sequence A
AS MDI 90 ug then Proventil 90 ug
|
Treatment Sequence B
Proventil 90 ug then AS MDI 90 ug
|
|---|---|---|
|
Washout
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
mITT Population
Baseline characteristics by cohort
| Measure |
mITT Population
n=46 Participants
The mITT Analysis Set is defined as a subset of the ITT Analysis Set including subjects who received treatment and had post-treatment efficacy data from both Treatment Periods. Data judged to be impacted by major protocol deviations are determined prior to database lock in a blinded fashion and excluded per the statistical protocol deviation plan. Statistical tabulations and analyses are by randomized treatment, but data obtained after subjects received an incorrect treatment are excluded from the affected periods
|
|---|---|
|
Age, Continuous
|
34.2 Years
STANDARD_DEVIATION 7.4 • n=45 Participants • mITT Population
|
|
Sex: Female, Male
Female
|
22 Participants
n=45 Participants • mITT Population
|
|
Sex: Female, Male
Male
|
23 Participants
n=45 Participants • mITT Population
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=45 Participants • mITT Population
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=45 Participants • mITT Population
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=45 Participants • mITT Population
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=45 Participants • mITT Population
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=45 Participants • mITT Population
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=45 Participants • mITT Population
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=45 Participants • mITT Population
|
|
Race (NIH/OMB)
White
|
34 Participants
n=45 Participants • mITT Population
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=45 Participants • mITT Population
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=45 Participants • mITT Population
|
PRIMARY outcome
Timeframe: At the two study treatment visits, FEV1 (forced expiratory volume in 1 second) will be measured prior to drug administration and 5 times, once at 30 minutes after each of the 5 dosesForced expiratory volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation
Outcome measures
| Measure |
AS MDI
n=45 Participants
AS MDI 90 μg 1+1+2+4+8 inhalations of 90 μg per inhalation
|
Proventil
n=45 Participants
Proventil 1+1+2+4+8 inhalations of 90 μg per inhalation
|
|---|---|---|
|
Baseline-adjusted FEV1 30 Minutes After Each Cumulative Dose
Cumulative Dose - 180 μg
|
0.548 Liter
Interval 0.432 to 0.665
|
0.586 Liter
Interval 0.469 to 0.702
|
|
Baseline-adjusted FEV1 30 Minutes After Each Cumulative Dose
Cumulative Dose - 360 μg
|
0.619 Liter
Interval 0.502 to 0.737
|
0.647 Liter
Interval 0.529 to 0.765
|
|
Baseline-adjusted FEV1 30 Minutes After Each Cumulative Dose
Cumulative Dose - 720 μg
|
0.659 Liter
Interval 0.544 to 0.775
|
0.690 Liter
Interval 0.575 to 0.805
|
|
Baseline-adjusted FEV1 30 Minutes After Each Cumulative Dose
Dose 1 - 90 μg
|
0.421 Liter
Interval 0.3 to 0.543
|
0.488 Liter
Interval 0.367 to 0.61
|
|
Baseline-adjusted FEV1 30 Minutes After Each Cumulative Dose
Cumulative Dose - 1440 μg
|
0.721 Liter
Interval 0.602 to 0.84
|
0.805 Liter
Interval 0.686 to 0.925
|
SECONDARY outcome
Timeframe: Over 6 hours post dose on Day 1The baseline-adjusted FEV1 AUC0-6 is the area under the curve for change from baseline calculated using the trapezoidal rule and normalized by dividing the AUC by the length of follow up post the last cumulative dose (typically 6 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose) normalized for length of follow up).
Outcome measures
| Measure |
AS MDI
n=45 Participants
AS MDI 90 μg 1+1+2+4+8 inhalations of 90 μg per inhalation
|
Proventil
n=45 Participants
Proventil 1+1+2+4+8 inhalations of 90 μg per inhalation
|
|---|---|---|
|
Baseline-adjusted FEV1 AUC0-6 After the Last Cumulative Dose
|
0.561 Liter
Interval 0.448 to 0.674
|
0.602 Liter
Interval 0.489 to 0.715
|
Adverse Events
AS MDI
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Proventil
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AS MDI
n=45 participants at risk
AS MDI 90 μg 1+1+2+4+8 inhalations of 90 μg per inhalation
|
Proventil
n=46 participants at risk
Proventil 1+1+2+4+8 inhalations of 90 μg per inhalation
|
|---|---|---|
|
General disorders
Feeling Jittery
|
6.7%
3/45 • Number of events 3 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug
Serious Adverse Events were collected from the time the subject signed informed consent until study completion for a maximum of 44 days. This reporting time frame includes the screening period, the two active treatment periods, and the follow up period (i.e. 3-7 days after last dose of study drug).
|
13.0%
6/46 • Number of events 6 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug
Serious Adverse Events were collected from the time the subject signed informed consent until study completion for a maximum of 44 days. This reporting time frame includes the screening period, the two active treatment periods, and the follow up period (i.e. 3-7 days after last dose of study drug).
|
|
Nervous system disorders
Tremor
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug
Serious Adverse Events were collected from the time the subject signed informed consent until study completion for a maximum of 44 days. This reporting time frame includes the screening period, the two active treatment periods, and the follow up period (i.e. 3-7 days after last dose of study drug).
|
4.3%
2/46 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug
Serious Adverse Events were collected from the time the subject signed informed consent until study completion for a maximum of 44 days. This reporting time frame includes the screening period, the two active treatment periods, and the follow up period (i.e. 3-7 days after last dose of study drug).
|
|
Nervous system disorders
Headache
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug
Serious Adverse Events were collected from the time the subject signed informed consent until study completion for a maximum of 44 days. This reporting time frame includes the screening period, the two active treatment periods, and the follow up period (i.e. 3-7 days after last dose of study drug).
|
0.00%
0/46 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug
Serious Adverse Events were collected from the time the subject signed informed consent until study completion for a maximum of 44 days. This reporting time frame includes the screening period, the two active treatment periods, and the follow up period (i.e. 3-7 days after last dose of study drug).
|
|
Investigations
Blood Potassium decreased
|
0.00%
0/45 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug
Serious Adverse Events were collected from the time the subject signed informed consent until study completion for a maximum of 44 days. This reporting time frame includes the screening period, the two active treatment periods, and the follow up period (i.e. 3-7 days after last dose of study drug).
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug
Serious Adverse Events were collected from the time the subject signed informed consent until study completion for a maximum of 44 days. This reporting time frame includes the screening period, the two active treatment periods, and the follow up period (i.e. 3-7 days after last dose of study drug).
|
|
Nervous system disorders
Dizziness
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug
Serious Adverse Events were collected from the time the subject signed informed consent until study completion for a maximum of 44 days. This reporting time frame includes the screening period, the two active treatment periods, and the follow up period (i.e. 3-7 days after last dose of study drug).
|
0.00%
0/46 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug
Serious Adverse Events were collected from the time the subject signed informed consent until study completion for a maximum of 44 days. This reporting time frame includes the screening period, the two active treatment periods, and the follow up period (i.e. 3-7 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/45 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug
Serious Adverse Events were collected from the time the subject signed informed consent until study completion for a maximum of 44 days. This reporting time frame includes the screening period, the two active treatment periods, and the follow up period (i.e. 3-7 days after last dose of study drug).
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug
Serious Adverse Events were collected from the time the subject signed informed consent until study completion for a maximum of 44 days. This reporting time frame includes the screening period, the two active treatment periods, and the follow up period (i.e. 3-7 days after last dose of study drug).
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug
Serious Adverse Events were collected from the time the subject signed informed consent until study completion for a maximum of 44 days. This reporting time frame includes the screening period, the two active treatment periods, and the follow up period (i.e. 3-7 days after last dose of study drug).
|
0.00%
0/46 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug
Serious Adverse Events were collected from the time the subject signed informed consent until study completion for a maximum of 44 days. This reporting time frame includes the screening period, the two active treatment periods, and the follow up period (i.e. 3-7 days after last dose of study drug).
|
Additional Information
Colin Reisner, MD FCCP, FAAAAI
Pearl Therapeutics, Inc, a Member of the AstraZeneca Group
Phone: 9739750321
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent it's opinions, or the opinions of the publication committee, if these differ with the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER