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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Albuterol Sulfate
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The participant has had at least 1 episode of a severe CAE over the past 12 months before screening. If on a biologic (for example, omalizumab, mepolizumab, or reslizumab) and/or post-bronchial thermoplasty, exacerbation has occurred after these interventions.
  • The participant is using a moderate-dose inhaled corticosteroid (ICS) equivalent to at least 440 mcg daily of fluticasone propionate.
  • The participant's baseline asthma therapy regimen, including oral corticosteroids, leukotriene antagonists, 5-lipoxygenase inhibitors, long-acting beta agonist (LABA), long-acting muscarinic agent, or cromolyn, biologicals, theophylline, or mepolizumab, is allowed.
  • The participant must be willing and able to comply with study requirements as specified in the protocol, including the use of a wearable accelerometer for the subset of participants who consent to use of the device.
  • The participant is willing to discontinue all other rescue or maintenance short-acting beta 2 agonist (SABA) or antimuscarinic agents and replace them with the study-provided ABS eMDPI for the duration of the trial.

  • Women of childbearing potential (not surgically sterile or at least 2 years postmenopausal) must have exclusively same-sex partners or use a highly effective method of birth control and must agree to continue the use of this method for the duration of the study and for 30 days after discontinuation of the investigational medicinal product (IMP).

    • Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

  • The participant has any clinically significant medical condition (treated or untreated) that, in the opinion of the investigator, would interfere with participation in the study.
  • The participant has any other confounding underlying lung disorder other than asthma.
  • The participant has used an investigational drug within 5 half-lives of it being discontinued or 1 month of baseline visit, whichever is longer.
  • The participant is a pregnant or lactating woman, or plans to become pregnant during the study. Note: Any woman becoming pregnant during the study will be withdrawn from the study.
  • The participant is known to be allergic to albuterol or any of the excipients in the IMP or rescue medication formulation (that is, lactose). Dietary lactose intolerance does not exclude the participant from inclusion in the study or as per the investigator's medical discretion.

  • The participant has a history or presence of "silent" infections, including positive testing for human immunodeficiency virus types 1 and 2, hepatitis B, hepatitis C, and tuberculosis.

    • Additional criteria apply, please contact the investigator for more information

Sites / Locations

  • Teva Investigational Site 13964
  • Teva Investigational Site 13959
  • Teva Investigational Site 13954
  • Teva Investigational Site 13923
  • Teva Investigational Site 13961
  • Teva Investigational Site 13933
  • Teva Investigational Site 13946
  • Teva Investigational Site 13921
  • Teva Investigational Site 13942
  • Teva Investigational Site 13927
  • Teva Investigational Site 13948
  • Teva Investigational Site 13934
  • Teva Investigational Site 13931
  • Teva Investigational Site 13926
  • Teva Investigational Site 13963
  • Teva Investigational Site 13943
  • Teva Investigational Site 13925
  • Teva Investigational Site 13958
  • Teva Investigational Site 13940
  • Teva Investigational Site 13937
  • Teva Investigational Site 13965
  • Teva Investigational Site 13919
  • Teva Investigational Site 13947
  • Teva Investigational Site 13960
  • Teva Investigational Site 13932
  • Teva Investigational Site 13922
  • Teva Investigational Site 13945
  • Teva Investigational Site 13936
  • Teva Investigational Site 13953
  • Teva Investigational Site 13928
  • Teva Investigational Site 13955
  • Teva Investigational Site 13949
  • Teva Investigational Site 13929
  • Teva Investigational Site 13941
  • Teva Investigational Site 13951
  • Teva Investigational Site 13938
  • Teva Investigational Site 13924
  • Teva Investigational Site 13962
  • Teva Investigational Site 13920
  • Teva Investigational Site 13930
  • Teva Investigational Site 13939
  • Teva Investigational Site 13957
  • Teva Investigational Site 13952
  • Teva Investigational Site 13956

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ABS eMDPI

Arm Description

Participants will receive 90 mcg of ABS via an 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.

Outcomes

Primary Outcome Measures

Clinical Asthma Exacerbation (CAE) Rate: Percentage of Participants Who Experienced at Least 1 Moderate or Severe CAE
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.
Total Number of Inhalations in the Days Preceding the Peak of a Severe 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 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.
Number of Days Prior to the Peak of a Severe CAE When Albuterol Use Increased
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).
Number of Albuterol Uses in the 24 Hours Preceding a Severe 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 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.

Secondary Outcome Measures

Number of Participants With Adverse Events (AEs)
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'.

Full Information

First Posted
November 17, 2016
Last Updated
November 5, 2021
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02969408
Brief Title
A Study to Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Asthma
Official Title
A 12-Week, Open-Label Study to Evaluate the Relationship Between Use of Albuterol eMDPI, an Inhaled Short-Acting Beta Agonist "Rescue" Agent With an eModule, and Exacerbations in Patients (18 Years of Age or Older) With Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 13, 2017 (Actual)
Primary Completion Date
February 2, 2018 (Actual)
Study Completion Date
February 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a Phase 3B, 12-week, multicenter, open-label study to evaluate the relationship between albuterol sulfate (ABS) eMDPI and clinical asthma exacerbation (CAE) in adult participants at least 18 years of age with exacerbation-prone asthma. The ABS eMDPI dose will be 90 micrograms (mcg), 1 to 2 inhalations every 4 hours as needed, but participant dosing will not be limited to this dosing regimen. The purpose of this study is to evaluate the relationship between albuterol dosing and CAE.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
397 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABS eMDPI
Arm Type
Experimental
Arm Description
Participants will receive 90 mcg of ABS via an 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.
Intervention Type
Drug
Intervention Name(s)
Albuterol Sulfate
Intervention Description
Albuterol sulfate will be administered as per the dose and schedule specified in the arm.
Primary Outcome Measure Information:
Title
Clinical Asthma Exacerbation (CAE) Rate: Percentage of Participants Who Experienced at Least 1 Moderate or Severe CAE
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
Title
Total Number of Inhalations in the Days Preceding the Peak of a Severe CAE
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
Title
Number of Days Prior to the Peak of a Severe CAE When Albuterol Use Increased
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
Title
Number of Albuterol Uses in the 24 Hours Preceding a Severe CAE
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
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs)
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The participant has had at least 1 episode of a severe CAE over the past 12 months before screening. If on a biologic (for example, omalizumab, mepolizumab, or reslizumab) and/or post-bronchial thermoplasty, exacerbation has occurred after these interventions. The participant is using a moderate-dose inhaled corticosteroid (ICS) equivalent to at least 440 mcg daily of fluticasone propionate. The participant's baseline asthma therapy regimen, including oral corticosteroids, leukotriene antagonists, 5-lipoxygenase inhibitors, long-acting beta agonist (LABA), long-acting muscarinic agent, or cromolyn, biologicals, theophylline, or mepolizumab, is allowed. The participant must be willing and able to comply with study requirements as specified in the protocol, including the use of a wearable accelerometer for the subset of participants who consent to use of the device. The participant is willing to discontinue all other rescue or maintenance short-acting beta 2 agonist (SABA) or antimuscarinic agents and replace them with the study-provided ABS eMDPI for the duration of the trial. Women of childbearing potential (not surgically sterile or at least 2 years postmenopausal) must have exclusively same-sex partners or use a highly effective method of birth control and must agree to continue the use of this method for the duration of the study and for 30 days after discontinuation of the investigational medicinal product (IMP). Additional criteria apply, please contact the investigator for more information Exclusion Criteria: The participant has any clinically significant medical condition (treated or untreated) that, in the opinion of the investigator, would interfere with participation in the study. The participant has any other confounding underlying lung disorder other than asthma. The participant has used an investigational drug within 5 half-lives of it being discontinued or 1 month of baseline visit, whichever is longer. The participant is a pregnant or lactating woman, or plans to become pregnant during the study. Note: Any woman becoming pregnant during the study will be withdrawn from the study. The participant is known to be allergic to albuterol or any of the excipients in the IMP or rescue medication formulation (that is, lactose). Dietary lactose intolerance does not exclude the participant from inclusion in the study or as per the investigator's medical discretion. The participant has a history or presence of "silent" infections, including positive testing for human immunodeficiency virus types 1 and 2, hepatitis B, hepatitis C, and tuberculosis. Additional criteria apply, please contact the investigator for more information
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teva Medical Expert, MD
Organizational Affiliation
Teva Branded Pharmaceutical Products R&D, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Teva Investigational Site 13964
City
Litchfield Park
State/Province
Arizona
ZIP/Postal Code
85340
Country
United States
Facility Name
Teva Investigational Site 13959
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
Teva Investigational Site 13954
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Teva Investigational Site 13923
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Teva Investigational Site 13961
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Teva Investigational Site 13933
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Teva Investigational Site 13946
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Teva Investigational Site 13921
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Facility Name
Teva Investigational Site 13942
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Teva Investigational Site 13927
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Teva Investigational Site 13948
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Teva Investigational Site 13934
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
Teva Investigational Site 13931
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Teva Investigational Site 13926
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Teva Investigational Site 13963
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Teva Investigational Site 13943
City
Michigan City
State/Province
Indiana
ZIP/Postal Code
46360
Country
United States
Facility Name
Teva Investigational Site 13925
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Teva Investigational Site 13958
City
Fort Mitchell
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Teva Investigational Site 13940
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
Teva Investigational Site 13937
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Teva Investigational Site 13965
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Teva Investigational Site 13919
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Teva Investigational Site 13947
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123-4303
Country
United States
Facility Name
Teva Investigational Site 13960
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08724
Country
United States
Facility Name
Teva Investigational Site 13932
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States
Facility Name
Teva Investigational Site 13922
City
Verona
State/Province
New Jersey
ZIP/Postal Code
07044
Country
United States
Facility Name
Teva Investigational Site 13945
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Teva Investigational Site 13936
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Teva Investigational Site 13953
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Teva Investigational Site 13928
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
Facility Name
Teva Investigational Site 13955
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73131
Country
United States
Facility Name
Teva Investigational Site 13949
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Teva Investigational Site 13929
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Teva Investigational Site 13941
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Teva Investigational Site 13951
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Teva Investigational Site 13938
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Teva Investigational Site 13924
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Teva Investigational Site 13962
City
Boerne
State/Province
Texas
ZIP/Postal Code
78006
Country
United States
Facility Name
Teva Investigational Site 13920
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Teva Investigational Site 13930
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Teva Investigational Site 13939
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78230
Country
United States
Facility Name
Teva Investigational Site 13957
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78251
Country
United States
Facility Name
Teva Investigational Site 13952
City
South Burlington
State/Province
Vermont
ZIP/Postal Code
05403
Country
United States
Facility Name
Teva Investigational Site 13956
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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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