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Trial record 10 of 857 for:    ALBUTEROL

Efficacy of Albuterol SPIROMAX® in Adult and Adolescent Patients With Exercise-Induced Bronchoconstriction (EIB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01791972
Recruitment Status : Completed
First Posted : February 15, 2013
Results First Posted : May 19, 2015
Last Update Posted : June 18, 2015
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Exercise-Induced Bronchoconstriction (EIB)
Interventions Drug: Albuterol Spiromax
Drug: Placebo Spiromax
Enrollment 38
Recruitment Details  
Pre-assignment Details 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study, 23 were excluded on the basis of inclusion/exclusion criteria, 2 patients withdrew consent, and 1 patient was withdrawn for other reason(s) before the baseline visit.
Arm/Group Title Albuterol Spiromax / Placebo Spiromax Placebo Spiromax / Albuterol Spiromax
Hide Arm/Group Description 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, (2 inhalations), single dose on Day 1. Albuterol Spiromax 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on approximately Day 7.
Period Title: Overall Study
Started 19 19
Completed 19 19
Not Completed 0 0
Arm/Group Title Albuterol Spiromax / Placebo Spiromax Placebo Spiromax / Albuterol Spiromax Total
Hide Arm/Group Description 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, (2 inhalations), single dose on Day 1. Albuterol Spiromax 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on approximately Day 7. Total of all reporting groups
Overall Number of Baseline Participants 19 19 38
Hide Baseline Analysis Population Description
Randomized participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 19 participants 38 participants
31.7  (7.11) 31.9  (8.87) 31.8  (7.93)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
<18 years 1 1 2
>=18 years 18 18 36
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
Female
9
  47.4%
10
  52.6%
19
  50.0%
Male
10
  52.6%
9
  47.4%
19
  50.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
White 14 16 30
Black 4 2 6
Asian 0 1 1
Other 1 0 1
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
Hispanic or Latino 2 2 4
Non-Hispanic and non-Latino 17 17 34
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 19 participants 19 participants 38 participants
82.7  (15.54) 74.2  (21.04) 78.4  (18.75)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 19 participants 19 participants 38 participants
171.4  (12.06) 169.8  (11.46) 170.6  (11.63)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 19 participants 19 participants 38 participants
28.1  (4.00) 25.3  (4.58) 26.7  (4.47)
1.Primary Outcome
Title Maximum Percentage Fall From Baseline in Forced Expiratory Volume in 1 Second (FEV1) up to 60 Minutes After the Exercise Challenge
Hide Description

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.

Time Frame Days 1 and 7; up to 60 minutes post-exercise challenge
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Albuterol Spiromax 180 mcg Placebo Spiromax
Hide Arm/Group Description:
Single dose of Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation)
Single dose of Placebo Spiromax (2 inhalations)
Overall Number of Participants Analyzed 38 38
Mean (Standard Error)
Unit of Measure: percentage change from baseline FEV1
6.21  (1.443) 22.38  (1.444)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albuterol Spiromax 180 mcg, Placebo Spiromax
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Significance level is 0.05.
Method mixed-effect analysis of covariance
Comments Fixed effects of sequence, trt group, period, and center, within period baseline FEV1 as a covariate, and random effect for patient within sequence.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -16.2
Confidence Interval (2-Sided) 95%
-20.19 to -12.14
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.982
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Whose Maximum Percentage Decrease From the Baseline Forced Expiratory Volume in 1 Second (FEV1) Post-Exercise Challenge Was <10%
Hide Description 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.
Time Frame Days 1 and 7; up to 60 minutes post-exercise challenge
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Albuterol Spiromax 180 mcg Placebo Spiromax
Hide Arm/Group Description:
Single dose of Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation)
Single dose of Placebo Spiromax (2 inhalations)
Overall Number of Participants Analyzed 38 38
Measure Type: Number
Unit of Measure: percentage of participants
84.21 15.79
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albuterol Spiromax 180 mcg, Placebo Spiromax
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Terms for treatment and period, computed with the generalized estimating equations (GEE) algorithm, which adjusts for potential correlation between measurements on the same patient. Significance level of 0.05.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.53 to 0.84
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.075
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Participants Whose Maximum Percentage Decrease From the Baseline Forced Expiratory Volume in 1 Second (FEV1) Post-Exercise Challenge Was >20%
Hide Description 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.
Time Frame Days 1 and 7; up to 60 minutes post-exercise challenge
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Albuterol Spiromax 180 mcg Placebo Spiromax
Hide Arm/Group Description:
Single dose of Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation)
Single dose of Placebo Spiromax (2 inhalations)
Overall Number of Participants Analyzed 38 38
Measure Type: Number
Unit of Measure: participants
1 22
Time Frame Days 1-14
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Albuterol Spiromax 180 mcg Placebo Spiromax
Hide Arm/Group Description Single dose of Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation) Single dose of Placebo Spiromax (2 inhalations)
All-Cause Mortality
Albuterol Spiromax 180 mcg Placebo Spiromax
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Albuterol Spiromax 180 mcg Placebo Spiromax
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/38 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Albuterol Spiromax 180 mcg Placebo Spiromax
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/38 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Teva Branded Pharmaceutical Products, R&D Inc.
Organization: Director, Clinical Research
Phone: 1-215-591-3000
EMail: ustevatrials@tevapharm.com
Layout table for additonal information
Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01791972     History of Changes
Other Study ID Numbers: ABS-AS-302
First Submitted: February 12, 2013
First Posted: February 15, 2013
Results First Submitted: May 1, 2015
Results First Posted: May 19, 2015
Last Update Posted: June 18, 2015