Trial Outcomes & Findings for Safety Study of Albuterol Spiromax® in Subjects With Asthma (NCT NCT01698320)
NCT ID: NCT01698320
Last Updated: 2015-08-19
Results Overview
Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
364 participants
Primary outcome timeframe
Day 1 to Week 12
Results posted on
2015-08-19
Participant Flow
Of the 33 patients who were screened but not enrolled, 28 were excluded on the basis of inclusion/exclusion criteria, 2 patients withdrew consent, and 3 patients were lost to follow-up before the baseline visit.
Participant milestones
| Measure |
All Enrolled Subjects
Includes subjects who were enrolled in study and participated in the single-blind (subjects were blinded) run-in period in which subjects used the inhaler with placebo and maintained the diary for about one week prior to randomization and starting the 12-week double-blind period.
|
Placebo MDPI-Albuterol MDPI
During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.
|
Albuterol MDPI-Albuterol MDPI
During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.
|
|---|---|---|---|
|
Run-In Period (Week -1 to Day 0)
STARTED
|
364
|
0
|
0
|
|
Run-In Period (Week -1 to Day 0)
COMPLETED
|
337
|
0
|
0
|
|
Run-In Period (Week -1 to Day 0)
NOT COMPLETED
|
27
|
0
|
0
|
|
12-Week Double-Blind Period
STARTED
|
0
|
169
|
168
|
|
12-Week Double-Blind Period
Safety Population
|
0
|
170
|
168
|
|
12-Week Double-Blind Period
COMPLETED
|
0
|
165
|
156
|
|
12-Week Double-Blind Period
NOT COMPLETED
|
0
|
4
|
12
|
|
40-Week Open-Label Period
STARTED
|
0
|
165
|
156
|
|
40-Week Open-Label Period
COMPLETED
|
0
|
146
|
146
|
|
40-Week Open-Label Period
NOT COMPLETED
|
0
|
19
|
10
|
Reasons for withdrawal
| Measure |
All Enrolled Subjects
Includes subjects who were enrolled in study and participated in the single-blind (subjects were blinded) run-in period in which subjects used the inhaler with placebo and maintained the diary for about one week prior to randomization and starting the 12-week double-blind period.
|
Placebo MDPI-Albuterol MDPI
During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.
|
Albuterol MDPI-Albuterol MDPI
During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.
|
|---|---|---|---|
|
Run-In Period (Week -1 to Day 0)
Inclusion/exclusion criteria
|
24
|
0
|
0
|
|
Run-In Period (Week -1 to Day 0)
Withdrawal by Subject
|
1
|
0
|
0
|
|
Run-In Period (Week -1 to Day 0)
Lost to Follow-up
|
1
|
0
|
0
|
|
Run-In Period (Week -1 to Day 0)
Other
|
1
|
0
|
0
|
|
12-Week Double-Blind Period
Adverse Event
|
0
|
1
|
1
|
|
12-Week Double-Blind Period
Withdrawal by Subject
|
0
|
2
|
2
|
|
12-Week Double-Blind Period
Protocol Violation
|
0
|
0
|
2
|
|
12-Week Double-Blind Period
Pregnancy
|
0
|
1
|
1
|
|
12-Week Double-Blind Period
Sponsor requested subject withdrawal
|
0
|
0
|
2
|
|
12-Week Double-Blind Period
Lost to Follow-up
|
0
|
0
|
4
|
|
40-Week Open-Label Period
Adverse Event
|
0
|
3
|
2
|
|
40-Week Open-Label Period
Withdrawal by Subject
|
0
|
11
|
7
|
|
40-Week Open-Label Period
Pregnancy
|
0
|
2
|
1
|
|
40-Week Open-Label Period
Sponsor requested subject withdrawal
|
0
|
1
|
0
|
|
40-Week Open-Label Period
Lost to Follow-up
|
0
|
2
|
0
|
Baseline Characteristics
Safety Study of Albuterol Spiromax® in Subjects With Asthma
Baseline characteristics by cohort
| Measure |
Placebo MDPI-Albuterol MDPI
n=169 Participants
During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.
|
Albuterol MDPI-Albuterol MDPI
n=168 Participants
During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.
|
Total
n=337 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.1 years
STANDARD_DEVIATION 15.14 • n=5 Participants
|
36.6 years
STANDARD_DEVIATION 15.04 • n=7 Participants
|
36.8 years
STANDARD_DEVIATION 15.07 • n=5 Participants
|
|
Age, Customized
12-17 years
|
19 participants
n=5 Participants
|
25 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Age, Customized
18-64 years
|
143 participants
n=5 Participants
|
135 participants
n=7 Participants
|
278 participants
n=5 Participants
|
|
Age, Customized
65+ years
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
129 participants
n=5 Participants
|
125 participants
n=7 Participants
|
254 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
35 participants
n=5 Participants
|
38 participants
n=7 Participants
|
73 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
25 participants
n=5 Participants
|
28 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
144 participants
n=5 Participants
|
140 participants
n=7 Participants
|
284 participants
n=5 Participants
|
|
Weight
|
82.3 kg
STANDARD_DEVIATION 21.09 • n=5 Participants
|
81.2 kg
STANDARD_DEVIATION 21.4 • n=7 Participants
|
81.8 kg
STANDARD_DEVIATION 21.22 • n=5 Participants
|
|
Height
|
167.4 cm
STANDARD_DEVIATION 8.67 • n=5 Participants
|
168.6 cm
STANDARD_DEVIATION 9.52 • n=7 Participants
|
168.0 cm
STANDARD_DEVIATION 9.11 • n=5 Participants
|
|
Body Mass Index
|
29.2 kg/m^2
STANDARD_DEVIATION 6.96 • n=5 Participants
|
28.5 kg/m^2
STANDARD_DEVIATION 6.81 • n=7 Participants
|
28.8 kg/m^2
STANDARD_DEVIATION 6.88 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Week 12Population: Safety population
Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Outcome measures
| Measure |
Placebo MDPI-Albuterol MDPI
n=170 Participants
During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.
|
Albuterol MDPI-Albuterol MDPI
n=168 Participants
During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.
|
|---|---|---|
|
Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period)
Any adverse event
|
105 participants
|
84 participants
|
|
Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period)
Severe adverse event
|
6 participants
|
3 participants
|
|
Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period)
Treatment-related adverse event
|
1 participants
|
5 participants
|
|
Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period)
Deaths
|
0 participants
|
0 participants
|
|
Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period)
Other serious adverse events
|
1 participants
|
0 participants
|
|
Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period)
Withdrawn from treatment due to adverse events
|
1 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Weeks 13-52Population: Safety population
Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Outcome measures
| Measure |
Placebo MDPI-Albuterol MDPI
n=165 Participants
During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.
|
Albuterol MDPI-Albuterol MDPI
n=156 Participants
During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.
|
|---|---|---|
|
Participants With Adverse Experiences During Weeks 13-52 (Open-Label Period)
Any adverse event
|
106 participants
|
94 participants
|
|
Participants With Adverse Experiences During Weeks 13-52 (Open-Label Period)
Severe adverse event
|
12 participants
|
13 participants
|
|
Participants With Adverse Experiences During Weeks 13-52 (Open-Label Period)
Treatment-related adverse event
|
2 participants
|
1 participants
|
|
Participants With Adverse Experiences During Weeks 13-52 (Open-Label Period)
Deaths
|
0 participants
|
0 participants
|
|
Participants With Adverse Experiences During Weeks 13-52 (Open-Label Period)
Other serious adverse events
|
3 participants
|
4 participants
|
|
Participants With Adverse Experiences During Weeks 13-52 (Open-Label Period)
Withdrawn from treatment due to adverse events
|
2 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Weeks 0 (screening visit), 12, and 52Population: Safety population. Participants with assessments at each time point are reported.
A standard 12-lead ECG was performed at screening, week 12, and week 52 or early termination/discontinuation. The ECG recording methods were centralized and standardized across all study participants. A centralized cardiologist was responsible for providing all ECG interpretations.
Outcome measures
| Measure |
Placebo MDPI-Albuterol MDPI
n=170 Participants
During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.
|
Albuterol MDPI-Albuterol MDPI
n=168 Participants
During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.
|
|---|---|---|
|
Electrocardiogram (ECG) Results At Weeks 0, 12, and 52
Week 0: Normal
|
151 participants
|
154 participants
|
|
Electrocardiogram (ECG) Results At Weeks 0, 12, and 52
Week 0: Abnormal, not clinically relevant
|
19 participants
|
14 participants
|
|
Electrocardiogram (ECG) Results At Weeks 0, 12, and 52
Week 0: Abnormal, clinically relevant
|
0 participants
|
0 participants
|
|
Electrocardiogram (ECG) Results At Weeks 0, 12, and 52
Week 12: Normal (n=166, 155)
|
143 participants
|
140 participants
|
|
Electrocardiogram (ECG) Results At Weeks 0, 12, and 52
Week 12: Abnormal, not clinically relevant
|
23 participants
|
15 participants
|
|
Electrocardiogram (ECG) Results At Weeks 0, 12, and 52
Week 12: Abnormal, clinically relevant
|
0 participants
|
0 participants
|
|
Electrocardiogram (ECG) Results At Weeks 0, 12, and 52
Week 52: Normal (n=152, 161)
|
138 participants
|
148 participants
|
|
Electrocardiogram (ECG) Results At Weeks 0, 12, and 52
Week 52: Abnormal, not clinically relevant
|
23 participants
|
13 participants
|
|
Electrocardiogram (ECG) Results At Weeks 0, 12, and 52
Week 52: Abnormal, clinically relevant
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Week 0, Week 12 and Week 52Population: Safety population. Participants with assessments at each time point are reported.
Participants were seated at least 2 minutes before blood pressure measurements were obtained by either an electronic or manual sphygmomanometer. Week 12 values represent change from Week 0. Week 52 values represent change from Week 12.
Outcome measures
| Measure |
Placebo MDPI-Albuterol MDPI
n=170 Participants
During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.
|
Albuterol MDPI-Albuterol MDPI
n=168 Participants
During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.
|
|---|---|---|
|
Change From Baseline in Blood Pressure Measurements to Week 12 and Week 52
Systolic BP Week 12 (n=166, 155)
|
1.0 mmHg
Standard Deviation 11.27
|
0.2 mmHg
Standard Deviation 10.99
|
|
Change From Baseline in Blood Pressure Measurements to Week 12 and Week 52
Systolic BP Week 52 (n=159, 155)
|
-0.4 mmHg
Standard Deviation 11.54
|
0.7 mmHg
Standard Deviation 10.31
|
|
Change From Baseline in Blood Pressure Measurements to Week 12 and Week 52
Diastolic BP Week 12 (n=166, 155)
|
0.0 mmHg
Standard Deviation 9.16
|
0.3 mmHg
Standard Deviation 7.62
|
|
Change From Baseline in Blood Pressure Measurements to Week 12 and Week 52
Diastolic BP Week 52 (n=159, 155)
|
0.2 mmHg
Standard Deviation 9.14
|
1.0 mmHg
Standard Deviation 8.15
|
PRIMARY outcome
Timeframe: Week 0, Week 12 and Week 52Population: Safety population. Participants with assessments at each time point are reported.
Participants were seated at least 2 minutes before pulse measurements were obtained by radial pulse. Week 12 values represent change from Week 0. Week 52 values represent change from Week 12.
Outcome measures
| Measure |
Placebo MDPI-Albuterol MDPI
n=170 Participants
During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.
|
Albuterol MDPI-Albuterol MDPI
n=168 Participants
During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.
|
|---|---|---|
|
Change From Baseline in Pulse Measurements to Week 12 and Week 52
Pulse Week 12 (n=166, 155)
|
-0.1 beats/minute
Standard Deviation 9.40
|
0.9 beats/minute
Standard Deviation 9.53
|
|
Change From Baseline in Pulse Measurements to Week 12 and Week 52
Pulse Week 52 (n=159, 155)
|
-0.4 beats/minute
Standard Deviation 10.08
|
-0.3 beats/minute
Standard Deviation 9.77
|
PRIMARY outcome
Timeframe: Weeks 0, 12 and 52Population: Safety population. Participants with assessments at each time point are reported.
The physical exam was performed by a qualified healthcare professional, and when possible, the same qualified healthcare professional that performed the physical examination at study screening performed all the scheduled physical examinations. Abnormalities and clinical relevance were determined by the qualified healthcare professional. HEENT = head, eyes, ears, nose, throat
Outcome measures
| Measure |
Placebo MDPI-Albuterol MDPI
n=170 Participants
During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.
|
Albuterol MDPI-Albuterol MDPI
n=168 Participants
During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.
|
|---|---|---|
|
Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
General appearance - Week 0 (n=170, 167)
|
0 participants
|
0 participants
|
|
Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
General appearance - Week 12 (n=166, 155)
|
1 participants
|
0 participants
|
|
Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
General appearance - Week 52 (n=162, 161)
|
0 participants
|
0 participants
|
|
Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
HEENT - Week 0 (n=170, 167)
|
0 participants
|
0 participants
|
|
Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
HEENT - Week 12 (n=166, 155)
|
1 participants
|
1 participants
|
|
Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
HEENT - Week 52 (n=162, 161)
|
2 participants
|
2 participants
|
|
Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
Chest and lungs - Week 0 (n=170, 167)
|
0 participants
|
0 participants
|
|
Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
Chest and lungs - Week 12 (n=166, 155)
|
1 participants
|
1 participants
|
|
Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
Chest and lungs - Week 52 (n=162, 161)
|
3 participants
|
2 participants
|
|
Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
Heart - Week 0 (n=170, 167)
|
0 participants
|
0 participants
|
|
Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
Heart - Week 12 (n=166, 155)
|
0 participants
|
0 participants
|
|
Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
Heart - Week 52 (n=162, 161)
|
0 participants
|
0 participants
|
|
Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
Abdomen - Week 0 (n=168, 167)
|
0 participants
|
0 participants
|
|
Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
Abdomen - Week 12 (n=166, 155)
|
0 participants
|
0 participants
|
|
Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
Abdomen - Week 52 (n=162, 161)
|
0 participants
|
1 participants
|
|
Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
Musculoskeletal - Week 0 (n=169, 167)
|
0 participants
|
0 participants
|
|
Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
Musculoskeletal - Week 12 (n=166, 155)
|
0 participants
|
0 participants
|
|
Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
Musculoskeletal - Week 52 (n=162, 161)
|
0 participants
|
0 participants
|
|
Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
Skin - Week 0 (n=169, 167)
|
0 participants
|
0 participants
|
|
Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
Skin - Week 12 (n=167, 155)
|
0 participants
|
0 participants
|
|
Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
Skin - Week 52 (n=162, 161)
|
0 participants
|
0 participants
|
|
Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
Lymph Nodes - Week 0 (n=169, 167)
|
0 participants
|
0 participants
|
|
Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
Lymph Nodes - Week 120 (n=166, 155)
|
0 participants
|
0 participants
|
|
Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
Lymph Nodes - Week 52 (n=162, 161)
|
0 participants
|
0 participants
|
|
Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
Neurological - Week 0 (n=169, 167)
|
0 participants
|
0 participants
|
|
Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
Neurological - Week 12 (n=166, 155)
|
0 participants
|
0 participants
|
|
Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
Neurological - Week 52 (n=162, 161)
|
0 participants
|
0 participants
|
|
Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
Extremities/back - Week 0 (n=169, 167)
|
0 participants
|
0 participants
|
|
Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
Extremities/back - Week 12 (n=166, 155)
|
0 participants
|
0 participants
|
|
Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
Extremities/back - Week 52 (n=162, 160)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 52Device Ruggedness: Reports of any problems/malfunction of the device (e.g., lack of efficacy, problems/malfunction after the device is dropped or sustains physical impact).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 52Device In Vitro Evaluations - All used study inhalers will be collected and a random selection of inhalers will be tested as follows: * Fifty (50) Albuterol Spiromax® inhalers used during weeks 0-12 will be randomly selected for in vitro testing * Fifty (50) Albuterol Spiromax® inhalers used during weeks 12-52 will be randomly selected for in vitro performance testing
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 52Daily AM PEF will be recorded throughout the duration of the study to provide information on the subject's asthma status in order to assist in distinguishing between the use of back-up rescue medication related to an increased need for asthma symptom relief from that related to an issue with the Albuterol Spiromax® rescue inhaler.
Outcome measures
Outcome data not reported
Adverse Events
Albuterol MDPI - Double-blind Period
Serious events: 0 serious events
Other events: 51 other events
Deaths: 0 deaths
Placebo MDPI - Double-blind Period
Serious events: 1 serious events
Other events: 80 other events
Deaths: 0 deaths
Albuterol MDPI (Formerly Placebo) - Open Label Period
Serious events: 3 serious events
Other events: 64 other events
Deaths: 0 deaths
Albuterol MDPI (Formerly Albuterol) - Open Label Period
Serious events: 4 serious events
Other events: 67 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Albuterol MDPI - Double-blind Period
n=168 participants at risk
Albuterol multi-dose dry powder inhaler (MDPI or Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period.
|
Placebo MDPI - Double-blind Period
n=170 participants at risk
Placebo delivered using a multi-dose dry powder inhaler (MDPI or Spiromax) as 2 inhalations four times a day for the 12 week double-blind period.
|
Albuterol MDPI (Formerly Placebo) - Open Label Period
n=169 participants at risk
After completing 12 weeks of placebo QID treatment, participants continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg/inhalation as required (PRN).
|
Albuterol MDPI (Formerly Albuterol) - Open Label Period
n=168 participants at risk
After completing 12 weeks of albuterol QID treatment, participants continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg/inhalation as required (PRN).
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/168 • Day 1 to Week 52
|
0.00%
0/170 • Day 1 to Week 52
|
0.00%
0/169 • Day 1 to Week 52
|
0.60%
1/168 • Number of events 1 • Day 1 to Week 52
|
|
Infections and infestations
Cellulitis
|
0.00%
0/168 • Day 1 to Week 52
|
0.00%
0/170 • Day 1 to Week 52
|
0.00%
0/169 • Day 1 to Week 52
|
0.60%
1/168 • Number of events 1 • Day 1 to Week 52
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/168 • Day 1 to Week 52
|
0.00%
0/170 • Day 1 to Week 52
|
0.59%
1/169 • Number of events 1 • Day 1 to Week 52
|
0.00%
0/168 • Day 1 to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.00%
0/168 • Day 1 to Week 52
|
0.00%
0/170 • Day 1 to Week 52
|
0.00%
0/169 • Day 1 to Week 52
|
0.60%
1/168 • Number of events 1 • Day 1 to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/168 • Day 1 to Week 52
|
0.00%
0/170 • Day 1 to Week 52
|
0.00%
0/169 • Day 1 to Week 52
|
0.60%
1/168 • Number of events 1 • Day 1 to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/168 • Day 1 to Week 52
|
0.00%
0/170 • Day 1 to Week 52
|
0.59%
1/169 • Number of events 1 • Day 1 to Week 52
|
0.00%
0/168 • Day 1 to Week 52
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/168 • Day 1 to Week 52
|
0.59%
1/170 • Number of events 1 • Day 1 to Week 52
|
0.00%
0/169 • Day 1 to Week 52
|
0.00%
0/168 • Day 1 to Week 52
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/168 • Day 1 to Week 52
|
0.00%
0/170 • Day 1 to Week 52
|
0.59%
1/169 • Number of events 1 • Day 1 to Week 52
|
0.00%
0/168 • Day 1 to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/168 • Day 1 to Week 52
|
0.00%
0/170 • Day 1 to Week 52
|
0.59%
1/169 • Number of events 1 • Day 1 to Week 52
|
0.00%
0/168 • Day 1 to Week 52
|
Other adverse events
| Measure |
Albuterol MDPI - Double-blind Period
n=168 participants at risk
Albuterol multi-dose dry powder inhaler (MDPI or Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period.
|
Placebo MDPI - Double-blind Period
n=170 participants at risk
Placebo delivered using a multi-dose dry powder inhaler (MDPI or Spiromax) as 2 inhalations four times a day for the 12 week double-blind period.
|
Albuterol MDPI (Formerly Placebo) - Open Label Period
n=169 participants at risk
After completing 12 weeks of placebo QID treatment, participants continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg/inhalation as required (PRN).
|
Albuterol MDPI (Formerly Albuterol) - Open Label Period
n=168 participants at risk
After completing 12 weeks of albuterol QID treatment, participants continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg/inhalation as required (PRN).
|
|---|---|---|---|---|
|
Infections and infestations
Bronchitis
|
1.8%
3/168 • Number of events 4 • Day 1 to Week 52
|
5.3%
9/170 • Number of events 10 • Day 1 to Week 52
|
3.6%
6/169 • Number of events 7 • Day 1 to Week 52
|
3.6%
6/168 • Number of events 6 • Day 1 to Week 52
|
|
Infections and infestations
Influenza
|
1.8%
3/168 • Number of events 3 • Day 1 to Week 52
|
5.9%
10/170 • Number of events 11 • Day 1 to Week 52
|
0.59%
1/169 • Number of events 1 • Day 1 to Week 52
|
1.2%
2/168 • Number of events 2 • Day 1 to Week 52
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
10/168 • Number of events 12 • Day 1 to Week 52
|
10.0%
17/170 • Number of events 22 • Day 1 to Week 52
|
9.5%
16/169 • Number of events 20 • Day 1 to Week 52
|
11.9%
20/168 • Number of events 26 • Day 1 to Week 52
|
|
Infections and infestations
Sinusitis
|
4.8%
8/168 • Number of events 9 • Day 1 to Week 52
|
7.6%
13/170 • Number of events 14 • Day 1 to Week 52
|
5.9%
10/169 • Number of events 11 • Day 1 to Week 52
|
11.3%
19/168 • Number of events 23 • Day 1 to Week 52
|
|
Infections and infestations
Upper respiratory tract infection
|
13.7%
23/168 • Number of events 26 • Day 1 to Week 52
|
18.2%
31/170 • Number of events 36 • Day 1 to Week 52
|
16.0%
27/169 • Number of events 36 • Day 1 to Week 52
|
8.9%
15/168 • Number of events 16 • Day 1 to Week 52
|
|
Nervous system disorders
Headache
|
6.0%
10/168 • Number of events 19 • Day 1 to Week 52
|
7.1%
12/170 • Number of events 16 • Day 1 to Week 52
|
4.7%
8/169 • Number of events 25 • Day 1 to Week 52
|
6.0%
10/168 • Number of events 18 • Day 1 to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
7/168 • Number of events 8 • Day 1 to Week 52
|
7.1%
12/170 • Number of events 13 • Day 1 to Week 52
|
10.7%
18/169 • Number of events 19 • Day 1 to Week 52
|
6.5%
11/168 • Number of events 14 • Day 1 to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.2%
7/168 • Number of events 7 • Day 1 to Week 52
|
6.5%
11/170 • Number of events 11 • Day 1 to Week 52
|
5.9%
10/169 • Number of events 12 • Day 1 to Week 52
|
6.0%
10/168 • Number of events 10 • Day 1 to Week 52
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 1-215-591-3000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER