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

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Albuterol Sulfate

• Study Type: Interventional
• Enrollment (Actual): 397
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Litchfield Park, Arizona, United States, 85340
      • Teva Investigational Site 13964
  • California
    • Bakersfield, California, United States, 93301
      • Teva Investigational Site 13959
    • Los Angeles, California, United States, 90048
      • Teva Investigational Site 13954
    • Orange, California, United States, 92868
      • Teva Investigational Site 13923
    • Riverside, California, United States, 92506
      • Teva Investigational Site 13961
  • Colorado
    • Centennial, Colorado, United States, 80112
      • Teva Investigational Site 13933
  • Florida
    • Clearwater, Florida, United States, 33765
      • Teva Investigational Site 13946
    • Loxahatchee Groves, Florida, United States, 33470
      • Teva Investigational Site 13921
    • Miami, Florida, United States, 33176
      • Teva Investigational Site 13942
    • Miami, Florida, United States, 33186
      • Teva Investigational Site 13927
    • Orlando, Florida, United States, 32803
      • Teva Investigational Site 13948
    • Orlando, Florida, United States, 32819
      • Teva Investigational Site 13934
    • Ormond Beach, Florida, United States, 32174
      • Teva Investigational Site 13931
    • Sarasota, Florida, United States, 34239
      • Teva Investigational Site 13926
  • Georgia
    • Savannah, Georgia, United States, 31406
      • Teva Investigational Site 13963
  • Indiana
    • Michigan City, Indiana, United States, 46360
      • Teva Investigational Site 13943
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Teva Investigational Site 13925
  • Kentucky
    • Fort Mitchell, Kentucky, United States, 41017
      • Teva Investigational Site 13958
    • Owensboro, Kentucky, United States, 42301
      • Teva Investigational Site 13940
  • Maine
    • Bangor, Maine, United States, 04401
      • Teva Investigational Site 13937
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Teva Investigational Site 13965
  • Montana
    • Missoula, Montana, United States, 59808
      • Teva Investigational Site 13919
  • Nebraska
    • Bellevue, Nebraska, United States, 68123-4303
      • Teva Investigational Site 13947
  • New Jersey
    • Brick, New Jersey, United States, 08724
      • Teva Investigational Site 13960
    • Piscataway, New Jersey, United States, 08854
      • Teva Investigational Site 13932
    • Verona, New Jersey, United States, 07044
      • Teva Investigational Site 13922
  • New York
    • Rochester, New York, United States, 14618
      • Teva Investigational Site 13945
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Teva Investigational Site 13936
  • Ohio
    • Cincinnati, Ohio, United States, 45231
      • Teva Investigational Site 13953
  • Oklahoma
    • Edmond, Oklahoma, United States, 73034
      • Teva Investigational Site 13928
    • Oklahoma City, Oklahoma, United States, 73131
      • Teva Investigational Site 13955
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Teva Investigational Site 13949
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Teva Investigational Site 13929
    • Greenville, South Carolina, United States, 29607
      • Teva Investigational Site 13941
    • Greenville, South Carolina, United States, 29615
      • Teva Investigational Site 13951
    • Spartanburg, South Carolina, United States, 29303
      • Teva Investigational Site 13938
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • Teva Investigational Site 13924
  • Texas
    • Boerne, Texas, United States, 78006
      • Teva Investigational Site 13962
    • Dallas, Texas, United States, 75231
      • Teva Investigational Site 13920
    • Houston, Texas, United States, 77099
      • Teva Investigational Site 13930
    • San Antonio, Texas, United States, 78230
      • Teva Investigational Site 13939
    • San Antonio, Texas, United States, 78251
      • Teva Investigational Site 13957
  • Vermont
    • South Burlington, Vermont, United States, 05403
      • Teva Investigational Site 13952
  • Virginia
    • Fairfax, Virginia, United States, 22030
      • Teva Investigational Site 13956

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABS eMDPI; 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.	Drug: Albuterol Sulfate; Albuterol sulfate will be administered as per the dose and schedule specified in the arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Day 1) to Week 12
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.	Baseline to Week 12
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).	Baseline to Week 12
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.	Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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'.	Baseline up to week 12

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2017
• Primary Completion (Actual): February 2, 2018
• Study Completion (Actual): February 2, 2018

Study Registration Dates

• First Submitted: November 17, 2016
• First Submitted That Met QC Criteria: November 17, 2016
• First Posted (Estimate): November 21, 2016

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 5, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol
• Other Study ID Numbers: ABS-AS-30064

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No