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Trial record 19 of 857 for:    ALBUTEROL

Efficacy and Safety Comparison of Albuterol Spiromax® and ProAir® Hydrofluoroalkane (HFA) in Pediatric Patients

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: NCT01899144
Recruitment Status : Completed
First Posted : July 15, 2013
Results First Posted : February 8, 2016
Last Update Posted : February 8, 2016
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: Albuterol Spiromax
Drug: ProAir HFA
Drug: Placebo
Enrollment 61
Recruitment Details Of the 102 patients screened, 61 patients at 14 centers in the US met entry criteria and were considered to be eligible for enrollment into the study. 41 patients were not enrolled: 33 were excluded due to inclusion criteria, 1 patient withdrew consent, 3 patients were lost to follow-up before the baseline visit, and 4 patients for other reasons.
Pre-assignment Details Participants were randomized in a 1:1:1:1:1:1:1:1:1:1 fashion into 10 treatment sequences with 6 participants in 9 of the sequences and 7 participants in the remaining sequence.
Arm/Group Title All Participants
Hide Arm/Group Description Participants were assigned to 1 of 10 possible treatment sequences for five treatments, separated by 2-7 days. Treatments were single inhalations of Albuterol MDPI 90 mcg, Albuterol MDPI 180 mcg, ProAir HFA MDI 90 mcg, ProAir HFA MDI 180 mcg, and placebo.
Period Title: Treatment Period 1
Started 61
Completed 61
Not Completed 0
Period Title: Treatment Period 2
Started 61
Completed 60 [1]
Not Completed 1
Reason Not Completed
Not specified             1
[1]
Last treatment taken by the patient who discontinued was placebo.
Period Title: Treatment Period 3
Started 60
Completed 58 [1]
Not Completed 2
Reason Not Completed
Not specified             2
[1]
Last treatment taken by patients who discontinued were ABS Spiromax 180 mcg and ABS Spiromax 90 mcg.
Period Title: Treatment Period 4
Started 58
Completed 58
Not Completed 0
Period Title: Treatment Period 5
Started 58
Completed 57 [1]
Not Completed 1
Reason Not Completed
Not specified             1
[1]
Last treatment taken by the patient who discontinued was ABS Spiromax 180 mcg.
Arm/Group Title All Participants
Hide Arm/Group Description Participants were assigned to 1 of 10 possible treatment sequences for five treatments, separated by 2-7 days. Treatments were single inhalations of Albuterol MDPI 90 mcg, Albuterol MDPI 180 mcg, ProAir HFA MDI 90 mcg, ProAir HFA MDI 180 mcg, and placebo.
Overall Number of Baseline Participants 61
Hide Baseline Analysis Population Description
Randomized participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 61 participants
9.0  (1.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants
Female
23
  37.7%
Male
38
  62.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 61 participants
White 28
Black 29
Other 4
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 61 participants
38.2  (12.8)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 61 participants
138.7  (10.2)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 61 participants
19.5  (4.35)
Duration of Asthma   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 61 participants
None 0
<3 months 0
3 to <6 months 0
6 months to <1 year 1
1 to <5 years 22
5 to <10 years 30
10 to <15 years 8
[1]
Measure Description: Time prior to study start when asthma was first diagnosed.
Duration of Previous Dry-Powder Inhaler (DPI) Experience  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 61 participants
None 46
<3 months 2
3 to <6 months 1
6 months to <1 year 3
1 to <5 years 9
5 to <10 years 0
10 to <15 years 0
Duration of Previous Metered-Dose Inhaler (MDI) Experience  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 61 participants
None 1
<3 months 1
3 to <6 months 0
6 months to <1 year 3
1 to <5 years 34
5 to <10 years 19
10 to <15 years 3
1.Primary Outcome
Title Baseline-Adjusted Area-Under-The-Percent-Predicted Forced Expiratory Volume In 1 Second (FEV1) Versus Time Curve Over 6 Hours Post-Dose
Hide Description

Percent predicted FEV1: measured FEV1 as a percent of the "predicted values" for the patients of similar characteristics. Predicted FEV1 values were computed and adjusted for age, height, and gender for patients aged 4-5 years (Eigen et al 2001) and for patients aged 6-11 years (Quanjer et al 1995) using ATS/European Thoracic Society (ERS) criteria applicable to pediatric patients (ATS/ERS 2007).

The percent predicted FEV1 (PPFEV1) area under the curve (AUC)0-6 was calculated using the linear trapezoidal rule, and baseline adjustment was made by subtracting the average of the 2 pre-dose PPFEV1 values from each post-dose PPFEV1 determination.

Time Frame Treatment visits 1-5 (approximately days 1, 6, 11, 16, and 21); -35 and -5 minutes prior to dosing and 5 (±2), 15 (±5), 30 (±5), 45 (±5), 60 (±5), 120 (±5), 180 (±5), 240 (±5), 300 (±5), and 360 (±5) minutes after the completion of study drug administrati
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all participants in the ITT population who received at least 1 dose of study medication, had a baseline assessment, and had at least 1 post baseline assessment.
Arm/Group Title Albuterol Spiromax 90 mcg Albuterol Spiromax 180 mcg ProAir HFA 90 mcg ProAir HFA 180 mcg Placebo
Hide Arm/Group Description:

At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.

In this arm, one of the DPIs contains Albuterol Spiromax 90 mcg; the other three devices contained placebo.

At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.

In this arm, both of the DPIs contain Albuterol Spiromax 90 mcg for a total dose of 180 mcg; the MDIs contained placebo.

At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.

In this arm, one of the MDIs contains ProAir HFA 90 mcg; the other three devices contained placebo.

At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.

In this arm, both of the MDIs contain ProAir HFA 90 mcg for a total dose of 180 mcg; the DPIs contained placebo.

At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind. In this arm, all devices contain placebo.
Overall Number of Participants Analyzed 58 59 59 59 59
Mean (Standard Error)
Unit of Measure: %predicted FEV1*hour
46.6  (6.27) 48.0  (6.24) 37.9  (6.25) 49.1  (6.26) 25.4  (6.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albuterol Spiromax 180 mcg, Placebo
Comments

The mean difference between each active group and placebo was tested in a sequential manner:

  • Albuterol MDPI 180 mcg to placebo
  • Albuterol MDPI 90 mcg to placebo
  • ProAir HFA 180 mcg to placebo
  • ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 22.6
Confidence Interval (2-Sided) 95%
13.00 to 32.20
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.87
Estimation Comments Active - Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Albuterol Spiromax 90 mcg, Placebo
Comments

The mean difference between each active group and placebo was tested in a sequential manner:

  • Albuterol MDPI 180 mcg to placebo
  • Albuterol MDPI 90 mcg to placebo
  • ProAir HFA 180 mcg to placebo
  • ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 21.2
Confidence Interval (2-Sided) 95%
11.6 to 30.81
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.87
Estimation Comments Active - Placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ProAir HFA 180 mcg, Placebo
Comments

The mean difference between each active group and placebo was tested in a sequential manner:

  • Albuterol MDPI 180 mcg to placebo
  • Albuterol MDPI 90 mcg to placebo
  • ProAir HFA 180 mcg to placebo
  • ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 23.7
Confidence Interval (2-Sided) 95%
14.13 to 33.23
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.85
Estimation Comments Active - Placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ProAir HFA 90 mcg, Placebo
Comments

The mean difference between each active group and placebo was tested in a sequential manner:

  • Albuterol MDPI 180 mcg to placebo
  • Albuterol MDPI 90 mcg to placebo
  • ProAir HFA 180 mcg to placebo
  • ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0107
Comments [Not Specified]
Method ANOVA
Comments Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 12.5
Confidence Interval (2-Sided) 95%
2.93 to 22.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.85
Estimation Comments Active - Placebo
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Albuterol Spiromax 90 mcg, Albuterol Spiromax 180 mcg
Comments Pre-specified, exploratory analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7772
Comments 0.05 level of significance
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-11.00 to 8.23
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.88
Estimation Comments 90 mcg - 180 mcg
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection ProAir HFA 90 mcg, ProAir HFA 180 mcg
Comments Pre-specified, exploratory analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0226
Comments 0.05 level of significance
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.2
Confidence Interval (2-Sided) 95%
-20.80 to -1.59
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.87
Estimation Comments 90 mcg - 180 mcg
2.Secondary Outcome
Title Baseline-Adjusted Area-Under-The- Forced Expiratory Volume In 1 Second (FEV1) Versus Time Curve Over 6 Hours Post-Dose (FEV1 AUC0-6)
Hide Description FEV1 AUC0-6 was calculated using the linear trapezoidal rule, and baseline adjustment was made by subtracting the average of the 2 pre-dose FEV1 values from each post-dose FEV1 determination.
Time Frame Treatment visits 1-5 (approximately days 1, 6, 11, 16, and 21); -35 and -5 minutes prior to dosing and 5 (±2), 15 (±5), 30 (±5), 45 (±5), 60 (±5), 120 (±5), 180 (±5), 240 (±5), 300 (±5), and 360 (±5) minutes after the completion of study drug administrati
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Albuterol Spiromax 90 mcg Albuterol Spiromax 180 mcg ProAir HFA 90 mcg ProAir HFA 180 mcg Placebo
Hide Arm/Group Description:

At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.

In this arm, one of the DPIs contains Albuterol Spiromax 90 mcg; the other three devices contained placebo.

At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.

In this arm, both of the DPIs contain Albuterol Spiromax 90 mcg for a total dose of 180 mcg; the MDIs contained placebo.

At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.

In this arm, one of the MDIs contains ProAir HFA 90 mcg; the other three devices contained placebo.

At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.

In this arm, both of the MDIs contain ProAir HFA 90 mcg for a total dose of 180 mcg; the DPIs contained placebo.

At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind. In this arm, all devices contain placebo.
Overall Number of Participants Analyzed 58 59 59 59 59
Mean (Standard Error)
Unit of Measure: L*hour
0.88  (0.14) 0.93  (0.14) 0.74  (0.14) 0.93  (0.14) 0.48  (0.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albuterol Spiromax 180 mcg, Placebo
Comments

The mean difference between each active group and placebo was tested in a sequential manner:

  • Albuterol MDPI 180 mcg to placebo
  • Albuterol MDPI 90 mcg to placebo
  • ProAir HFA 180 mcg to placebo
  • ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.45
Confidence Interval (2-Sided) 95%
0.26 to 0.64
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments Active - Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Albuterol Spiromax 90 mcg, Placebo
Comments

The mean difference between each active group and placebo was tested in a sequential manner:

  • Albuterol MDPI 180 mcg to placebo
  • Albuterol MDPI 90 mcg to placebo
  • ProAir HFA 180 mcg to placebo
  • ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.40
Confidence Interval (2-Sided) 95%
0.21 to 0.59
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments Active - Placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ProAir HFA 180 mcg, Placebo
Comments

The mean difference between each active group and placebo was tested in a sequential manner:

  • Albuterol MDPI 180 mcg to placebo
  • Albuterol MDPI 90 mcg to placebo
  • ProAir HFA 180 mcg to placebo
  • ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.45
Confidence Interval (2-Sided) 95%
0.26 to 0.64
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments Active - Placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ProAir HFA 90 mcg, Placebo
Comments

The mean difference between each active group and placebo was tested in a sequential manner:

  • Albuterol MDPI 180 mcg to placebo
  • Albuterol MDPI 90 mcg to placebo
  • ProAir HFA 180 mcg to placebo
  • ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0062
Comments [Not Specified]
Method ANOVA
Comments Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.26
Confidence Interval (2-Sided) 95%
0.08 to 0.45
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments Active - Placebo
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Albuterol Spiromax 90 mcg, Albuterol Spiromax 180 mcg
Comments Pre-specified, exploratory analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6342
Comments 0.05 level of significance
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-0.23 to 0.14
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments 90 mcg - 180 mcg
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection ProAir HFA 90 mcg, ProAir HFA 180 mcg
Comments Pre-specified, exploratory analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0488
Comments 0.05 level of significance
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.38 to 0.00
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments 90 mcg - 180 mcg
3.Secondary Outcome
Title Participants With Treatment-Emergent Adverse Events
Hide Description

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 as mild (no limitation of usual activities), moderate, or severe (inability to carry out usual 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.

Time Frame Day 1 up to Day 35
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all randomized patients who received at least 1 dose of randomized study medication. In this population, treatment was assigned based upon the treatment patients actually receive regardless of the treatment to which they were randomized.
Arm/Group Title Albuterol Spiromax 90 mcg Albuterol Spiromax 180 mcg ProAir HFA 90 mcg ProAir HFA 180 mcg Placebo
Hide Arm/Group Description:

At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.

In this arm, one of the DPIs contains Albuterol Spiromax 90 mcg; the other three devices contained placebo.

At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.

In this arm, both of the DPIs contain Albuterol Spiromax 90 mcg for a total dose of 180 mcg; the MDIs contained placebo.

At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.

In this arm, one of the MDIs contains ProAir HFA 90 mcg; the other three devices contained placebo.

At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.

In this arm, both of the MDIs contain ProAir HFA 90 mcg for a total dose of 180 mcg; the DPIs contained placebo.

At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind. In this arm, all devices contain placebo.
Overall Number of Participants Analyzed 61 61 61 61 61
Measure Type: Number
Unit of Measure: participants
Treatment-related AE 0 2 5 1 1
Severe TEAE 0 0 0 0 0
Related TEAE 0 0 0 0 0
Death 0 0 0 0 0
Serious AE 0 0 0 0 0
TEAE leading to withdrawal 0 0 0 0 0
Time Frame Day 1 up to Day 35
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Albuterol Spiromax 90 mcg Albuterol Spiromax 180 mcg ProAir HFA 90 mcg ProAir HFA 180 mcg Placebo
Hide Arm/Group Description

At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.

In this arm, one of the DPIs contains Albuterol Spiromax 90 mcg; the other three devices contained placebo.

At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.

In this arm, both of the DPIs contain Albuterol Spiromax 90 mcg for a total dose of 180 mcg; the MDIs contained placebo.

At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.

In this arm, one of the MDIs contains ProAir HFA 90 mcg; the other three devices contained placebo.

At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.

In this arm, both of the MDIs contain ProAir HFA 90 mcg for a total dose of 180 mcg; the DPIs contained placebo.

At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind. In this arm, all devices contain placebo.
All-Cause Mortality
Albuterol Spiromax 90 mcg Albuterol Spiromax 180 mcg ProAir HFA 90 mcg ProAir HFA 180 mcg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Albuterol Spiromax 90 mcg Albuterol Spiromax 180 mcg ProAir HFA 90 mcg ProAir HFA 180 mcg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/61 (0.00%)   0/61 (0.00%)   0/61 (0.00%)   0/61 (0.00%)   0/61 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Albuterol Spiromax 90 mcg Albuterol Spiromax 180 mcg ProAir HFA 90 mcg ProAir HFA 180 mcg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/61 (0.00%)   0/61 (0.00%)   3/61 (4.92%)   0/61 (0.00%)   0/61 (0.00%) 
Nervous system disorders           
Headache  1  0/61 (0.00%)  0/61 (0.00%)  3/61 (4.92%)  0/61 (0.00%)  0/61 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
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
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Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc
Phone: 215-591-3000
EMail: ustevatrials@tevapharm.com
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Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT01899144     History of Changes
Other Study ID Numbers: ABS-AS-202
First Submitted: July 8, 2013
First Posted: July 15, 2013
Results First Submitted: January 6, 2016
Results First Posted: February 8, 2016
Last Update Posted: February 8, 2016