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Trial record 27 of 857 for:    ALBUTEROL

A Study to Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Asthma

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ClinicalTrials.gov Identifier: NCT02969408
Recruitment Status : Completed
First Posted : November 21, 2016
Results First Posted : May 3, 2019
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Asthma
Intervention Drug: Albuterol Sulfate
Enrollment 397
Recruitment Details  
Pre-assignment Details A total of 449 participants with exacerbation-prone asthma were screened, of which 397 participants at 45 investigational centers in the US met entry criteria and were considered to be eligible for enrollment into the study.
Arm/Group Title ABS eMDPI
Hide Arm/Group Description Participants received 90 micrograms (mcg) of albuterol sulfate (ABS) via a multidose dry powder inhaler (MDPI) with an eModule (eMDPI) (sitting on the upper part of the device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other asthma and non-asthma medications as advised by their physician without changes unless deemed necessary by their physician.
Period Title: Overall Study
Started 397
Used ABS eMDPI at Least Once 370
Completed 381
Not Completed 16
Reason Not Completed
Adverse Event             2
Withdrawal by Subject             8
Lost to Follow-up             4
Protocol Violation             1
Other than specified             1
Arm/Group Title ABS eMDPI
Hide Arm/Group Description Participants received 90 mcg of ABS via eMDPI (sitting on the upper part of the device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other asthma and non-asthma medications as advised by their physician without changes unless deemed necessary by their physician.
Overall Number of Baseline Participants 397
Hide Baseline Analysis Population Description
The intent-to-treat (ITT) analysis set included all enrolled participants regardless of whether a participant took any investigational medicinal product (IMP).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 397 participants
50.1  (14.93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 397 participants
Female
318
  80.1%
Male
79
  19.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 397 participants
Hispanic or Latino
99
  24.9%
Not Hispanic or Latino
298
  75.1%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
American Indian or Alaska Native Number Analyzed 397 participants
4
   1.0%
Asian Number Analyzed 397 participants
3
   0.8%
Native Hawaiian or Other Pacific Islander Number Analyzed 397 participants
1
   0.3%
Black or African American Number Analyzed 397 participants
74
  18.6%
White Number Analyzed 397 participants
313
  78.8%
Other Number Analyzed 397 participants
2
   0.5%
Number of Asthma Exacerbations in the Past 12 Months   [1] 
Mean (Standard Deviation)
Unit of measure:  Exacerbations
Number Analyzed 394 participants
1.5  (1.29)
[1]
Measure Analysis Population Description: Here, 'number analyzed' signifies number of participants with asthma exacerbations.
1.Primary Outcome
Title Clinical Asthma Exacerbation (CAE) Rate: Percentage of Participants Who Experienced at Least 1 Moderate or Severe CAE
Hide Description

CAE was an occurrence of either severe CAE or moderate CAE. Severe CAE was defined as a CAE that involved worsening asthma such that the treating physician elected to administer prednisone (or equivalent glucocorticoid treatment) at least 10 milligrams (mg) prednisone equivalent above Baseline, for at least 3 days; and an unscheduled provider visit such as an office visit, urgent care visit, emergency care visit, or hospitalization.

Moderate CAE was defined as a CAE that involved worsening asthma such that the treating physician elected to administer prednisone (or equivalent glucocorticoid treatment) at least 10 mg prednisone equivalent above Baseline, for at least 3 days, or an unscheduled provider visit such as an office visit, urgent care visit, emergency care visit, or hospitalization associated with an increase in asthma therapy that did not qualify for severe CAE as defined above.

Time Frame Baseline (Day 1) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Arm/Group Title ABS eMDPI
Hide Arm/Group Description:
Participants received 90 mcg of ABS via eMDPI (sitting on the upper part of the device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other asthma and non-asthma medications as advised by their physician without changes unless deemed necessary by their physician.
Overall Number of Participants Analyzed 397
Measure Type: Number
Unit of Measure: percentage of participants
17
2.Primary Outcome
Title Total Number of Inhalations in the Days Preceding the Peak of a Severe CAE
Hide Description Severe CAE was defined as a CAE that involved worsening asthma such that the treating physician elected to administer prednisone (or equivalent glucocorticoid treatment) at least 10 mg prednisone equivalent above Baseline, for at least 3 days; and an unscheduled provider visit such as an office visit, urgent care visit, emergency care visit, or hospitalization. Total number of inhalations taken in 1 day (that is, the 24-hour period on the day prior to the date of the CAE symptom peak) and at 3, 5, 7, 10, 14, and 21 days preceding the date of the severe CAE symptom peak were reported.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all enrolled participants regardless of whether a participant took any IMP. Here, 'overall number of participants analyzed' signifies number of participants experiencing at least 1 severe CAE. Here, 'number analyzed' signifies participants who reported albuterol use in specified time interval.
Arm/Group Title ABS eMDPI
Hide Arm/Group Description:
Participants received 90 mcg of ABS via eMDPI (sitting on the upper part of the device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other asthma and non-asthma medications as advised by their physician without changes unless deemed necessary by their physician.
Overall Number of Participants Analyzed 37
Mean (Standard Deviation)
Unit of Measure: inhalations
Day 1 prior to CAE Number Analyzed 31 participants
5.9  (7.95)
Day 3 prior to CAE Number Analyzed 28 participants
6.1  (9.93)
Day 5 prior to CAE Number Analyzed 26 participants
3.6  (2.89)
Day 7 prior to CAE Number Analyzed 23 participants
4.0  (2.61)
Day 10 prior to CAE Number Analyzed 26 participants
4.5  (4.24)
Day 14 prior to CAE Number Analyzed 28 participants
3.2  (1.87)
Day 21 prior to CAE Number Analyzed 22 participants
4.0  (3.06)
3.Primary Outcome
Title Number of Days Prior to the Peak of a Severe CAE When Albuterol Use Increased
Hide Description Severe CAE was defined as a CAE that involved worsening asthma such that the treating physician elected to administer prednisone (or equivalent glucocorticoid treatment) at least 10 mg prednisone equivalent above Baseline, for at least 3 days; and an unscheduled provider visit such as an office visit, urgent care visit, emergency care visit, or hospitalization. Number of days prior to the peak of a severe CAE when albuterol use first increased to greater than (>) 4, >12, and >20 inhalations was reported. Participants were counted in more than 1 category (that is, all of the >20 inhalation participants were also counted in the >12 category, and in the >4 category).
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all enrolled participants regardless of whether a participant took any IMP. Here, 'overall number of participants analyzed'= number of participants experiencing at least 1 severe CAE. 'Number analyzed'= participants who had any single day prior to CAE where their albuterol use exceeded 4, 12, or 20 inhalations in that day.
Arm/Group Title ABS eMDPI
Hide Arm/Group Description:
Participants received 90 mcg of ABS via eMDPI (sitting on the upper part of the device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other asthma and non-asthma medications as advised by their physician without changes unless deemed necessary by their physician.
Overall Number of Participants Analyzed 37
Mean (Standard Deviation)
Unit of Measure: days
Albuterol use >4 inhalations Number Analyzed 29 participants
39.3  (26.79)
Albuterol use >12 inhalations Number Analyzed 9 participants
40.3  (26.95)
Albuterol use >20 inhalations Number Analyzed 6 participants
34.0  (30.84)
4.Primary Outcome
Title Number of Albuterol Uses in the 24 Hours Preceding a Severe CAE
Hide Description Severe CAE was defined as a CAE that involved worsening asthma such that the treating physician elected to administer prednisone (or equivalent glucocorticoid treatment) at least 10 mg prednisone equivalent above Baseline, for at least 3 days; and an unscheduled provider visit such as an office visit, urgent care visit, emergency care visit, or hospitalization. Number of albuterol inhalations used in the 24 hours preceeding a severe CAE is reported.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all enrolled participants regardless of whether a participant took any IMP. Here, 'overall number of participants analyzed' signifies number of participants who experienced at least 1 severe CAE and reported albuterol use in the 24 hours preceding a severe CAE.
Arm/Group Title ABS eMDPI
Hide Arm/Group Description:
Participants received 90 mcg of ABS via eMDPI (sitting on the upper part of the device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other asthma and non-asthma medications as advised by their physician without changes unless deemed necessary by their physician.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: inhalations
5.9  (7.95)
5.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description AE was defined 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 investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by investigator. SAEs included 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 participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of serious and non-serious AEs regardless of causality is located in ‘Reported Adverse Events module’.
Time Frame Baseline up to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Arm/Group Title ABS eMDPI
Hide Arm/Group Description:
Participants received 90 mcg of ABS via eMDPI (sitting on the upper part of the device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other asthma and non-asthma medications as advised by their physician without changes unless deemed necessary by their physician.
Overall Number of Participants Analyzed 397
Measure Type: Count of Participants
Unit of Measure: Participants
Any AEs
127
  32.0%
Severe AEs
41
  10.3%
Treatment-related AEs
2
   0.5%
Treatment-related severe AE
0
   0.0%
Serious AEs
6
   1.5%
AEs leading to discontinuation from study
2
   0.5%
CAE related AEs
73
  18.4%
Device-related AEs
3
   0.8%
AEs leading to death
0
   0.0%
Time Frame Baseline up to Week 12
Adverse Event Reporting Description ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
 
Arm/Group Title ABS eMDPI
Hide Arm/Group Description Participants received 90 mcg of ABS via eMDPI (sitting on the upper part of the device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other asthma and non-asthma medications as advised by their physician without changes unless deemed necessary by their physician.
All-Cause Mortality
ABS eMDPI
Affected / at Risk (%)
Total   0/397 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
ABS eMDPI
Affected / at Risk (%) # Events
Total   6/397 (1.51%)    
Cardiac disorders   
Acute myocardial infarction  1  1/397 (0.25%)  1
Myocardial infarction  1  1/397 (0.25%)  1
Gastrointestinal disorders   
Gastrooesophageal reflux disease  1  1/397 (0.25%)  1
Infections and infestations   
Gastroenteritis salmonella  1  1/397 (0.25%)  1
Pneumonia  1  1/397 (0.25%)  1
Injury, poisoning and procedural complications   
Facial bones fracture  1  1/397 (0.25%)  1
Fractured sacrum  1  1/397 (0.25%)  1
Humerus fracture  1  1/397 (0.25%)  1
Ilium fracture  1  1/397 (0.25%)  1
Pubis fracture  1  1/397 (0.25%)  1
Rib fracture  1  1/397 (0.25%)  1
Road traffic accident  1  1/397 (0.25%)  1
Metabolism and nutrition disorders   
Dehydration  1  1/397 (0.25%)  1
Hypokalaemia  1  1/397 (0.25%)  1
Nervous system disorders   
Migraine  1  1/397 (0.25%)  1
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure  1  1/397 (0.25%)  2
Asthma  1  2/397 (0.50%)  2
Pulmonary embolism  1  1/397 (0.25%)  1
Vascular disorders   
Deep vein thrombosis  1  1/397 (0.25%)  1
1
Term from vocabulary, MedDRA v19.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ABS eMDPI
Affected / at Risk (%) # Events
Total   68/397 (17.13%)    
Respiratory, thoracic and mediastinal disorders   
Asthma  1  68/397 (17.13%)  81
1
Term from vocabulary, MedDRA v19.1
Indicates events were collected by systematic assessment
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: NCT02969408     History of Changes
Other Study ID Numbers: ABS-AS-30064
First Submitted: November 17, 2016
First Posted: November 21, 2016
Results First Submitted: April 12, 2019
Results First Posted: May 3, 2019
Last Update Posted: May 3, 2019