Trial Outcomes & Findings for A Study to Evaluate the Effect of of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Sun Pharmaceuticals Industries Limited) (NCT NCT03528577)
NCT ID: NCT03528577
Last Updated: 2021-01-22
Results Overview
The primary pharmacodynamic endpoint is the post-dose PC20, which is the provocative concentration of methacholine challenge agent required to reduce the forced expiry volume in one second (FEV1) by 20%, following the administration of different doses of albuterol (or placebo) by inhalation. Primary analysis group -pharmacodynamic population.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
128 participants
Primary outcome timeframe
Approximately 15 minutes after last inhalation of study product
Results posted on
2021-01-22
Participant Flow
Treatments were administered according to a four-treatment, four-period, four-sequence design. 124 eligible subjects were randomized to each one of the four sequences: ABCD Sequence Sequence 1 : A B C D Sequence 2: D C B A Sequence 3: C A D B Sequence 4: B D A C
Participant milestones
| Measure |
Total
Treatment A: Zero-dose : Two different Reference Placebo inhalers and two different Test Placebo inhalers
Treatment B: 90 mcg of Reference : One Reference inhaler, one Reference Placebo inhaler, and two different Test Placebo inhalers
Treatment C: 180 mcg of Reference Two different Reference inhalers and two different Test Placebo inhalers
Treatment D: 90 mcg of Test One Test inhaler, one Test Placebo inhaler, and two different Reference Placebo inhalers
|
|---|---|
|
Sequence 1
STARTED
|
128
|
|
Sequence 1
COMPLETED
|
126
|
|
Sequence 1
NOT COMPLETED
|
2
|
|
Sequence 2
STARTED
|
128
|
|
Sequence 2
COMPLETED
|
125
|
|
Sequence 2
NOT COMPLETED
|
3
|
|
Sequence 3
STARTED
|
128
|
|
Sequence 3
COMPLETED
|
127
|
|
Sequence 3
NOT COMPLETED
|
1
|
|
Sequence 4
STARTED
|
128
|
|
Sequence 4
COMPLETED
|
125
|
|
Sequence 4
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Total
Treatment A: Zero-dose : Two different Reference Placebo inhalers and two different Test Placebo inhalers
Treatment B: 90 mcg of Reference : One Reference inhaler, one Reference Placebo inhaler, and two different Test Placebo inhalers
Treatment C: 180 mcg of Reference Two different Reference inhalers and two different Test Placebo inhalers
Treatment D: 90 mcg of Test One Test inhaler, one Test Placebo inhaler, and two different Reference Placebo inhalers
|
|---|---|
|
Sequence 1
Failed Spirometry
|
1
|
|
Sequence 1
Restricted medication
|
1
|
|
Sequence 2
Adverse Event
|
1
|
|
Sequence 2
Withdrawal by Subject
|
1
|
|
Sequence 2
Failed Spirometry
|
1
|
|
Sequence 3
Failed Spirometry
|
1
|
|
Sequence 4
Failed Spirometry
|
2
|
|
Sequence 4
Adverse Event
|
1
|
Baseline Characteristics
A Study to Evaluate the Effect of of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Sun Pharmaceuticals Industries Limited)
Baseline characteristics by cohort
| Measure |
Overall Baseline
n=128 Participants
Summary of Demographic Data and Baseline Characteristics (Safety Population)
|
|---|---|
|
Age, Continuous
|
34.7 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
96 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Tobacco Use
|
0 Participants
n=5 Participants
|
|
Number of years patient has suffered from symptoms caused by asthma
|
23.62 years
STANDARD_DEVIATION 13.17 • n=5 Participants
|
|
FEV1 (Pre-saline)
|
3.20 Litre
STANDARD_DEVIATION 0.72 • n=5 Participants
|
|
FEV1 (Post-saline)
|
3.23 Litre
STANDARD_DEVIATION 0.74 • n=5 Participants
|
|
PC20 FEV1
|
0.95 mg/mL
STANDARD_DEVIATION 1.36 • n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 15 minutes after last inhalation of study productPopulation: The statistical analysis was performed based on the Dose-Scale approach. This approach was referenced in FDA's draft Guidance on albuterol sulfate metered/inhalation and described in FDA's draft Guidance on Orlistat capsule. The PC20 data from various treatments (such as placebo, 90 mcg Test, 90 mcg Reference and 180 mcg Reference) from different study period was pooled to perform the Dose-Scale model using NONMEM. Therefore, per test arm values were not reported.
The primary pharmacodynamic endpoint is the post-dose PC20, which is the provocative concentration of methacholine challenge agent required to reduce the forced expiry volume in one second (FEV1) by 20%, following the administration of different doses of albuterol (or placebo) by inhalation. Primary analysis group -pharmacodynamic population.
Outcome measures
| Measure |
Primary Analysis Group
n=126 Participants
This group included all randomized subjects who:
1. completed at least 1 of the 4 randomized treatment periods with an evaluable PC20FEV1.
2. were compliant with study treatment dosing procedures.
3. did not use any restricted concomitant medications.
4. did not have any other significant protocol deviations.
|
|---|---|
|
Pharmacodynamic Endpoint Post-dose PC20
|
114 mg/mL
Interval 52.8 to 162.0
|
Adverse Events
Treatment A
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Treatment B
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Treatment C
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Treatment D
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A
n=125 participants at risk
Zero-dose
|
Treatment B
n=125 participants at risk
90 mcg of Reference (PROAIR® HFA)
|
Treatment C
n=123 participants at risk
180 mcg of Reference (PROAIR® HFA)
|
Treatment D
n=126 participants at risk
90 mcg of Test (Albuterol Sulfate HFA Inhalation Aerosol)
|
|---|---|---|---|---|
|
Infections and infestations
influenza
|
0.80%
1/125 • Number of events 1 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/123 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/126 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
|
Infections and infestations
Nasopharyngitis
|
0.80%
1/125 • Number of events 1 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.80%
1/125 • Number of events 1 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.81%
1/123 • Number of events 1 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.79%
1/126 • Number of events 1 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.80%
1/125 • Number of events 1 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/123 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/126 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.81%
1/123 • Number of events 1 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/126 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
|
General disorders
chest discomfort
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.81%
1/123 • Number of events 1 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/126 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
|
Gastrointestinal disorders
gastroenteritis
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.81%
1/123 • Number of events 1 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.79%
1/126 • Number of events 1 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.81%
1/123 • Number of events 1 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/126 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
|
Infections and infestations
Upper respiratory tract infection
|
1.6%
2/125 • Number of events 2 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.81%
1/123 • Number of events 1 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/126 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
|
Investigations
FEV1/FVC ratio
|
0.80%
1/125 • Number of events 1 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/123 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/126 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/123 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.79%
1/126 • Number of events 1 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
0.80%
1/125 • Number of events 1 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/123 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/126 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.81%
1/123 • Number of events 1 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/126 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.81%
1/123 • Number of events 1 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.79%
1/126 • Number of events 1 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
|
Nervous system disorders
dizziness
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.81%
1/123 • Number of events 1 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/126 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
|
Nervous system disorders
headache
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.81%
1/123 • Number of events 1 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/126 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
|
Nervous system disorders
tension headache
|
0.80%
1/125 • Number of events 1 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.80%
1/125 • Number of events 1 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/123 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/126 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
|
Psychiatric disorders
anxiety
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.80%
1/125 • Number of events 1 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/123 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/126 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.81%
1/123 • Number of events 1 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/126 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/123 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.79%
1/126 • Number of events 1 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
|
Vascular disorders
accelerated hypertension
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.80%
1/125 • Number of events 1 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/123 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/126 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
|
Vascular disorders
flushing
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/125 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.81%
1/123 • Number of events 1 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
0.00%
0/126 • 6 weeks
It is the approximate duration over which adverse event data were collected
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER