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Trial record 31 of 857 for:    ALBUTEROL

A 12-week Study to Compare the Efficacy and Safety of Albuterol Spiromax® Versus a Placebo in People 12 Years and Older With Persistent Asthma

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: NCT01424813
Recruitment Status : Completed
First Posted : August 29, 2011
Results First Posted : May 20, 2015
Last Update Posted : June 26, 2015
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: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: Placebo MDPI
Drug: Albuterol MDPI
Enrollment 158
Recruitment Details  
Pre-assignment Details 384 patients screened; 180 patients were excluded on the basis of inclusion criteria, 4 due to exclusion criteria, 21 patients withdrew consent, 1 patient was lost to follow-up before the baseline visit, 6 patients had other reasons, and 14 patients failed to meet randomization criteria at the end of the run-in period.
Arm/Group Title Placebo MDPI Albuterol MDPI
Hide Arm/Group Description Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks. Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
Period Title: Overall Study
Started 79 79
Treated 79 [1] 78 [1]
Completed 74 77
Not Completed 5 2
Reason Not Completed
Withdrawal by Subject             3             0
Protocol Violation             1             0
not specified             1             2
[1]
Safety set and full analysis set
Arm/Group Title Placebo MDPI Albuterol MDPI Total
Hide Arm/Group Description Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks. Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 79 79 158
Hide Baseline Analysis Population Description
Randomized participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 79 participants 79 participants 158 participants
40.3  (16.84) 37.3  (16.89) 38.8  (16.88)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 79 participants 79 participants 158 participants
12-17 years 14 16 30
18-64 years 63 60 123
65+ years 2 3 5
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 79 participants 158 participants
Female
47
  59.5%
44
  55.7%
91
  57.6%
Male
32
  40.5%
35
  44.3%
67
  42.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 79 participants 79 participants 158 participants
White 59 55 114
Black 18 21 39
Asian 2 0 2
American Indian or Alaskan Native 0 0 0
Pacific Islander 0 0 0
Other 0 3 3
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 79 participants 79 participants 158 participants
Hispanic or Latino 3 6 9
Not Hispanic or Latino 76 73 149
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 79 participants 79 participants 158 participants
82.4  (21.34) 83.4  (24.20) 82.9  (22.75)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 79 participants 79 participants 158 participants
169.5  (9.47) 168.9  (9.27) 169.2  (9.35)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 79 participants 79 participants 158 participants
28.6  (6.92) 29.2  (8.22) 28.9  (7.58)
1.Primary Outcome
Title Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period
Hide Description

FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average (by the trapezoidal rule) of FEV1 AUC 0-6 measures adjusted for the baseline measure (i.e., change from baseline at each timepoint) recorded on days 1, 8 and 85 of the treatment period. The baseline for each study day was the average of the 2 pre-dose FEV1 measurements on that study day.

FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min.

Time Frame Day 1, Day 8 and Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set which includes all participants in the intent-to-treat (ITT) population who received at least 1 dose of study medication and had at least 1 post-baseline assessment.
Arm/Group Title Placebo MDPI Albuterol MDPI
Hide Arm/Group Description:
Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
Overall Number of Participants Analyzed 79 78
Mean (Standard Error)
Unit of Measure: L*hr
0.28  (0.091) 1.11  (0.092)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo MDPI, Albuterol MDPI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Significance at the 0.05 level.
Method mixed-model repeated-measures (MMRM)
Comments Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.57 to 1.08
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.128
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 1
Hide Description

FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. The baseline-adjustment refers to change from baseline at each post dose timepoint recorded on Day 1.

FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min.

Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo MDPI Albuterol MDPI
Hide Arm/Group Description:
Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
Overall Number of Participants Analyzed 79 78
Mean (95% Confidence Interval)
Unit of Measure: L*hr
0.52
(0.24 to 0.79)
1.58
(1.30 to 1.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo MDPI, Albuterol MDPI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially [day 1, then day 8, then day 85] and terminated if individual results were not significant at the 0.05 level.
Method mixed model repeated measures (MMRM)
Comments Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.68 to 1.46
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.198
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 8
Hide Description

FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. The baseline-adjustment refers to change from baseline at each post dose timepoint recorded on Day 8.

FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min.

Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set of participants with data at the time point
Arm/Group Title Placebo MDPI Albuterol MDPI
Hide Arm/Group Description:
Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
Overall Number of Participants Analyzed 78 78
Mean (95% Confidence Interval)
Unit of Measure: L*hr
0.26
(0.03 to 0.49)
0.99
(0.76 to 1.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo MDPI, Albuterol MDPI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially [day 1, then day 8, then day 85] and terminated if individual results were not significant at the 0.05 level.
Method mixed model repeated measures (MMRM)
Comments Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.41 to 1.06
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.164
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 85
Hide Description

FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. The baseline-adjustment refers to change from baseline at each post dose timepoint recorded on Day 85.

FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min.

Time Frame Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set of participants with data at the time point
Arm/Group Title Placebo MDPI Albuterol MDPI
Hide Arm/Group Description:
Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
Overall Number of Participants Analyzed 77 77
Mean (95% Confidence Interval)
Unit of Measure: L*hr
0.06
(-0.15 to 0.28)
0.74
(0.53 to 0.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo MDPI, Albuterol MDPI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially [day 1, then day 8, then day 85] and terminated if individual results were not significant at the 0.05 level.
Method mixed model repeated measures (MMRM)
Comments Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.38 to 0.99
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.154
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Participants With 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 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.
Time Frame Day 1 to Day 92
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set
Arm/Group Title Placebo MDPI Albuterol MDPI
Hide Arm/Group Description:
Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
Overall Number of Participants Analyzed 79 78
Measure Type: Number
Unit of Measure: participants
Any adverse event 25 22
Severe adverse events 1 1
Treatment-related AE 1 1
Deaths 0 0
Other serious AEs 0 0
Withdrawn from study due to AEs 0 0
6.Secondary Outcome
Title Physical Examination Findings Shifts From Baseline to Endpoint by Treatment Group
Hide Description Physical exam was recorded as normal or abnormal based on physician assessment. Format for results is: Test Baseline/Endpoint HEENT = head, eyes, ears, nose, throat
Time Frame Day 1 (Baseline), Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only participants with both baseline and endpoint physical examination findings are summarized. Two placebo participants were missing endpoint physical examinations.
Arm/Group Title Placebo MDPI Albuterol MDPI
Hide Arm/Group Description:
Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
Overall Number of Participants Analyzed 77 78
Measure Type: Number
Unit of Measure: participants
General appearance Normal/Normal 76 76
General appearance Normal/Abnormal 0 0
General appearance Abnormal/Normal 1 1
General appearance Abnormal/Abnormal 0 1
HEENT Normal/Normal 46 50
HEENT Normal/Abnormal 12 5
HEENT Abnormal/Normal 11 12
HEENT Abnormal/Abnormal 8 11
Chest and Lungs Normal/Normal 66 67
Chest and Lungs Normal/Abnormal 8 4
Chest and Lungs Abnormal/Normal 2 7
Chest and Lungs Abnormal/abnormal 1 0
Heart Normal/Normal 76 77
Heart Normal/Abnormal 0 0
Heart Abnormal/Normal 1 1
Heart Abnormal/Abnormal 0 0
Abdomen Normal/Normal 75 77
Abdomen Normal/Abnormal 1 0
Abdomen Abnormal/Normal 0 1
Abdomen Abnormal/Abnormal 1 0
Musculoskeletal Normal/Normal 74 76
Musculoskeletal Normal/Abnormal 0 1
Musculoskeletal Abnormal/Normal 3 1
Musculoskeletal Abnormal/Abnormal 0 0
Skin Normal/Normal 75 73
Skin Normal/Abnormal 0 1
Skin Abnormal/Normal 2 4
Skin Abnormal/Abnormal 0 0
Lymph nodes Normal/Normal 77 78
Lymph nodes Normal/Abnormal 0 0
Lymph nodes Abnormal/Normal 0 0
Lymph nodes Abnormal/Abnormal 0 0
Neurological Normal/Normal 76 78
Neurological Normal/Abnormal 1 0
Neurological Abnormal/Normal 0 0
Neurological Abnormal/Abnormal 0 0
7.Secondary Outcome
Title Participants With Clinically Significant Vital Sign Assessments
Hide Description

For both standard and serial vital signs, participants were seated for at least 5 minutes before vital signs were assessed. Heart rate was obtained prior to the blood pressure measurement. Serial heart rate and blood pressure were conducted in the sitting position prior to the spirometry assessment; baseline measures were taken pre-dose at -30 ± 5 and -5 minutes on Day 1. Day 85 serial vital sign measures were taken in the sitting position prior to spirometry assessments pre-dose at -30 ± 5 and -5 minutes, then post-dose at 30 (±5) minutes, 1hr (± 10 min), 2hr (± 10 min), 3hr (± 10 min), 4hr (± 10 min), 5hr (± 10 min) and 6 hr (± 10 min).

Serial heart rate and blood pressure measurements that were elevated to the following criteria were considered clinically significant:

Systolic blood pressure: > 160 beats/minute Diastolic blood pressure: >100 beats/minute Heart rate: >120 beats/minute

Time Frame Day 8, Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Placebo MDPI Albuterol MDPI
Hide Arm/Group Description:
Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
Overall Number of Participants Analyzed 79 78
Measure Type: Number
Unit of Measure: participants
Systolic blood pressure - high 3 0
Diastolic blood pressure - high 3 1
Heart rate - high 0 1
8.Other Pre-specified Outcome
Title Percent Change From Baseline in FEV1 AUC 0-6 Over the 12-week Treatment Period
Hide Description [Not Specified]
Time Frame Day 1, Day 8, Day 85
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Percent Change From Baseline in FEV1 AUC 0-6
Hide Description [Not Specified]
Time Frame Day 1
Outcome Measure Data Not Reported
10.Other Pre-specified Outcome
Title Percent Change From Baseline in FEV1 AUC
Hide Description [Not Specified]
Time Frame Day 8
Outcome Measure Data Not Reported
11.Other Pre-specified Outcome
Title Percent Change From Baseline in FEV1 AUC
Hide Description [Not Specified]
Time Frame Day 85
Outcome Measure Data Not Reported
12.Other Pre-specified Outcome
Title Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose Over the 12-week Treatment Period
Hide Description [Not Specified]
Time Frame Day 1, Day 8, Day 85
Outcome Measure Data Not Reported
13.Other Pre-specified Outcome
Title Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 1
Hide Description [Not Specified]
Time Frame Day 1
Outcome Measure Data Not Reported
14.Other Pre-specified Outcome
Title Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 8
Hide Description [Not Specified]
Time Frame Day 8
Outcome Measure Data Not Reported
15.Other Pre-specified Outcome
Title Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 85
Hide Description [Not Specified]
Time Frame Day 85
Outcome Measure Data Not Reported
16.Other Pre-specified Outcome
Title Time to Onset of Effect (Change in FEV1 of 12% From Baseline Within 30 Minutes Postdose)
Hide Description [Not Specified]
Time Frame Day 1, Day 8, Day 85
Outcome Measure Data Not Reported
17.Other Pre-specified Outcome
Title Duration of Response Measured From the Time Post-dosing to the First Time After the Response Onset (Increase ≥12% Above Baseline) When the FEV1 Decreases to Less Than 12% Above Baseline (Within 6 Hours After Dosing) for Those Who Responded in 30 Minutes
Hide Description [Not Specified]
Time Frame Day 1, Day 8, Day 85
Outcome Measure Data Not Reported
18.Other Pre-specified Outcome
Title Time to Onset of Effect (Change in FEV1 of 15% From Baseline Within 30 Minutes Postdose)for Those Who Responded in 30 Minutes
Hide Description [Not Specified]
Time Frame Day 1, Day 8, Day 85
Outcome Measure Data Not Reported
19.Other Pre-specified Outcome
Title Duration of Response on Days 1, 8 and 85
Hide Description Duration of response measured from the time post-dosing to the first time after the response onset (increase ≥15% above baseline) when the FEV1 decreases to less than 15% above baseline (within 6 hours after dosing) for those who responded within 30 minutes
Time Frame Day 1, Day 8, Day 85
Outcome Measure Data Not Reported
20.Other Pre-specified Outcome
Title Percent of Symptom Free Days on the Patient Diary
Hide Description [Not Specified]
Time Frame Treatment days 1 through 85
Outcome Measure Data Not Reported
21.Other Pre-specified Outcome
Title Percent of Rescue Medication Free Days in the Patient Diary
Hide Description [Not Specified]
Time Frame Treatment days 1 through 85
Outcome Measure Data Not Reported
22.Other Pre-specified Outcome
Title Morning Peak Expiratory Flow Reading Reported on Patient Diary
Hide Description [Not Specified]
Time Frame Treatment days 1 through 85
Outcome Measure Data Not Reported
Time Frame Day 1 to Day 92
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Albuterol MDPI Placebo MDPI
Hide Arm/Group Description Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks. Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
All-Cause Mortality
Albuterol MDPI Placebo MDPI
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Albuterol MDPI Placebo MDPI
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/78 (0.00%)      0/79 (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 MDPI Placebo MDPI
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/78 (7.69%)      9/79 (11.39%)    
Infections and infestations     
Upper respiratory tract infection  1  3/78 (3.85%)  3 5/79 (6.33%)  5
Nervous system disorders     
Headache  1  3/78 (3.85%)  4 4/79 (5.06%)  5
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
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 215-591-3000
EMail: ustevatrials@tevapharm.com
Layout table for additonal information
Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT01424813     History of Changes
Other Study ID Numbers: ABS-AS-301
First Submitted: August 25, 2011
First Posted: August 29, 2011
Results First Submitted: May 1, 2015
Results First Posted: May 20, 2015
Last Update Posted: June 26, 2015