Trial Outcomes & Findings for Efficacy of Albuterol SPIROMAX® in Adult and Adolescent Patients With Exercise-Induced Bronchoconstriction (EIB) (NCT NCT01791972)
NCT ID: NCT01791972
Last Updated: 2015-06-18
Results Overview
A centralized spirometry data collection system was used to reduce FEV1 variability between and within patients and between each participating study center. The percentage fall was defined as 100\*(baseline-post baseline)/baseline. The baseline FEV1 is the test day FEV1 measured 5 minutes before the exercise challenge (30 minutes postdose). FEV1 post exercise challenge were measured 5 (±5), 10 (±5), 15 (±5), 30 (±5), and 60 (±10) minutes after completion of the exercise challenge. The exercise challenge consisted of the participant running on a motor-driven treadmill (with adjustable speed and incline). The treadmill was set at a speed and incline sufficient to increase the participant's heart rate to ≥80% of the maximum rate for age (220 bpm-age in years) for a period of either 6, 7, or 8 minutes using a stepped-exercise protocol in accordance with ATS guidelines (American Thoracic Society 2000). Conditions were repeated for subsequent challenges.
COMPLETED
PHASE3
38 participants
Days 1 and 7; up to 60 minutes post-exercise challenge
2015-06-18
Participant Flow
A total of 64 patients with EIB were screened. Of the 26 patients who did not participate in the study, 23 were excluded on the basis of inclusion/exclusion criteria, 2 patients withdrew consent, and 1 patient was withdrawn for other reason(s) before the baseline visit.
Participant milestones
| Measure |
Albuterol Spiromax / Placebo Spiromax
Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on Day 1. Placebo Spiromax (2 inhalations), single dose on approximately Day 7.
|
Placebo Spiromax / Albuterol Spiromax
Placebo Spiromax, (2 inhalations), single dose on Day 1. Albuterol Spiromax 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on approximately Day 7.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Albuterol SPIROMAX® in Adult and Adolescent Patients With Exercise-Induced Bronchoconstriction (EIB)
Baseline characteristics by cohort
| Measure |
Albuterol Spiromax / Placebo Spiromax
n=19 Participants
Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on Day 1. Placebo Spiromax (2 inhalations), single dose on approximately Day 7.
|
Placebo Spiromax / Albuterol Spiromax
n=19 Participants
Placebo Spiromax, (2 inhalations), single dose on Day 1. Albuterol Spiromax 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on approximately Day 7.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.7 years
STANDARD_DEVIATION 7.11 • n=5 Participants
|
31.9 years
STANDARD_DEVIATION 8.87 • n=7 Participants
|
31.8 years
STANDARD_DEVIATION 7.93 • n=5 Participants
|
|
Age, Customized
<18 years
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Age, Customized
>=18 years
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
14 participants
n=5 Participants
|
16 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic and non-Latino
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Weight
|
82.7 kg
STANDARD_DEVIATION 15.54 • n=5 Participants
|
74.2 kg
STANDARD_DEVIATION 21.04 • n=7 Participants
|
78.4 kg
STANDARD_DEVIATION 18.75 • n=5 Participants
|
|
Height
|
171.4 cm
STANDARD_DEVIATION 12.06 • n=5 Participants
|
169.8 cm
STANDARD_DEVIATION 11.46 • n=7 Participants
|
170.6 cm
STANDARD_DEVIATION 11.63 • n=5 Participants
|
|
Body Mass Index
|
28.1 kg/m^2
STANDARD_DEVIATION 4.00 • n=5 Participants
|
25.3 kg/m^2
STANDARD_DEVIATION 4.58 • n=7 Participants
|
26.7 kg/m^2
STANDARD_DEVIATION 4.47 • n=5 Participants
|
PRIMARY outcome
Timeframe: Days 1 and 7; up to 60 minutes post-exercise challengePopulation: Full analysis set
A centralized spirometry data collection system was used to reduce FEV1 variability between and within patients and between each participating study center. The percentage fall was defined as 100\*(baseline-post baseline)/baseline. The baseline FEV1 is the test day FEV1 measured 5 minutes before the exercise challenge (30 minutes postdose). FEV1 post exercise challenge were measured 5 (±5), 10 (±5), 15 (±5), 30 (±5), and 60 (±10) minutes after completion of the exercise challenge. The exercise challenge consisted of the participant running on a motor-driven treadmill (with adjustable speed and incline). The treadmill was set at a speed and incline sufficient to increase the participant's heart rate to ≥80% of the maximum rate for age (220 bpm-age in years) for a period of either 6, 7, or 8 minutes using a stepped-exercise protocol in accordance with ATS guidelines (American Thoracic Society 2000). Conditions were repeated for subsequent challenges.
Outcome measures
| Measure |
Albuterol Spiromax 180 mcg
n=38 Participants
Single dose of Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation)
|
Placebo Spiromax
n=38 Participants
Single dose of Placebo Spiromax (2 inhalations)
|
|---|---|---|
|
Maximum Percentage Fall From Baseline in Forced Expiratory Volume in 1 Second (FEV1) up to 60 Minutes After the Exercise Challenge
|
6.21 percentage change from baseline FEV1
Standard Error 1.443
|
22.38 percentage change from baseline FEV1
Standard Error 1.444
|
SECONDARY outcome
Timeframe: Days 1 and 7; up to 60 minutes post-exercise challengePopulation: Full analysis set
Participants were classified as protected if the maximum percentage decrease from baseline FEV1 after exercise was less than 10%. Data represents the percentage of participants who were classified as protected.
Outcome measures
| Measure |
Albuterol Spiromax 180 mcg
n=38 Participants
Single dose of Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation)
|
Placebo Spiromax
n=38 Participants
Single dose of Placebo Spiromax (2 inhalations)
|
|---|---|---|
|
Percentage of Participants Whose Maximum Percentage Decrease From the Baseline Forced Expiratory Volume in 1 Second (FEV1) Post-Exercise Challenge Was <10%
|
84.21 percentage of participants
|
15.79 percentage of participants
|
SECONDARY outcome
Timeframe: Days 1 and 7; up to 60 minutes post-exercise challengePopulation: Full analysis set
Participants were classified as unprotected if the maximum percentage decrease from baseline FEV1 after exercise was more than 20%. Data represents the number of participants who were classified as unprotected.
Outcome measures
| Measure |
Albuterol Spiromax 180 mcg
n=38 Participants
Single dose of Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation)
|
Placebo Spiromax
n=38 Participants
Single dose of Placebo Spiromax (2 inhalations)
|
|---|---|---|
|
Participants Whose Maximum Percentage Decrease From the Baseline Forced Expiratory Volume in 1 Second (FEV1) Post-Exercise Challenge Was >20%
|
1 participants
|
22 participants
|
Adverse Events
Albuterol Spiromax 180 mcg
Placebo Spiromax
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Teva Branded Pharmaceutical Products, R&D Inc.
Director, Clinical Research
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