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

NCT02969408 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ABS-AS-30064
• Study Type: interventional
• Target: 397
• Locations: 1 country
• Sites: 44

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  Baseline up to week 12

Study Arms (1)

ABS eMDPI

EXPERIMENTAL

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

Interventions

Albuterol Sulfate DRUG

Albuterol sulfate will be administered as per the dose and schedule specified in the arm.

ABS eMDPI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

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

Study Sites (44)

Teva Investigational Site 13964

Litchfield Park, Arizona, 85340, United States

Location

Teva Investigational Site 13959

Bakersfield, California, 93301, United States

Location

Teva Investigational Site 13954

Los Angeles, California, 90048, United States

Location

Teva Investigational Site 13923

Orange, California, 92868, United States

Location

Teva Investigational Site 13961

Riverside, California, 92506, United States

Location

Teva Investigational Site 13933

Centennial, Colorado, 80112, United States

Location

Teva Investigational Site 13946

Clearwater, Florida, 33765, United States

Location

Teva Investigational Site 13921

Loxahatchee Groves, Florida, 33470, United States

Location

Teva Investigational Site 13942

Miami, Florida, 33176, United States

Location

Teva Investigational Site 13927

Miami, Florida, 33186, United States

Location

Teva Investigational Site 13948

Orlando, Florida, 32803, United States

Location

Teva Investigational Site 13934

Orlando, Florida, 32819, United States

Location

Teva Investigational Site 13931

Ormond Beach, Florida, 32174, United States

Location

Teva Investigational Site 13926

Sarasota, Florida, 34239, United States

Location

Teva Investigational Site 13963

Savannah, Georgia, 31406, United States

Location

Teva Investigational Site 13943

Michigan City, Indiana, 46360, United States

Location

Teva Investigational Site 13925

Overland Park, Kansas, 66210, United States

Location

Teva Investigational Site 13958

Fort Mitchell, Kentucky, 41017, United States

Location

Teva Investigational Site 13940

Owensboro, Kentucky, 42301, United States

Location

Teva Investigational Site 13937

Bangor, Maine, 04401, United States

Location

Teva Investigational Site 13965

St Louis, Missouri, 63141, United States

Location

Teva Investigational Site 13919

Missoula, Montana, 59808, United States

Location

Teva Investigational Site 13947

Bellevue, Nebraska, 68123-4303, United States

Location

Teva Investigational Site 13960

Brick, New Jersey, 08724, United States

Location

Teva Investigational Site 13932

Piscataway, New Jersey, 08854, United States

Location

Teva Investigational Site 13922

Verona, New Jersey, 07044, United States

Location

Teva Investigational Site 13945

Rochester, New York, 14618, United States

Location

Teva Investigational Site 13936

High Point, North Carolina, 27262, United States

Location

Teva Investigational Site 13953

Cincinnati, Ohio, 45231, United States

Location

Teva Investigational Site 13928

Edmond, Oklahoma, 73034, United States

Location

Teva Investigational Site 13955

Oklahoma City, Oklahoma, 73131, United States

Location

Teva Investigational Site 13949

East Providence, Rhode Island, 02914, United States

Location

Teva Investigational Site 13929

Charleston, South Carolina, 29407, United States

Location

Teva Investigational Site 13941

Greenville, South Carolina, 29607, United States

Location

Teva Investigational Site 13951

Greenville, South Carolina, 29615, United States

Location

Teva Investigational Site 13938

Spartanburg, South Carolina, 29303, United States

Location

Teva Investigational Site 13924

Knoxville, Tennessee, 37909, United States

Location

Teva Investigational Site 13962

Boerne, Texas, 78006, United States

Location

Teva Investigational Site 13920

Dallas, Texas, 75231, United States

Location

Teva Investigational Site 13930

Houston, Texas, 77099, United States

Location

Teva Investigational Site 13939

San Antonio, Texas, 78230, United States

Location

Teva Investigational Site 13957

San Antonio, Texas, 78251, United States

Location

Teva Investigational Site 13952

South Burlington, Vermont, 05403, United States

Location

Teva Investigational Site 13956

Fairfax, Virginia, 22030, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

ustevatrials@tevapharm.com

215-591-3000

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: November 21, 2016
• Study Start: February 13, 2017
• Primary Completion: February 2, 2018
• Study Completion: February 2, 2018
• Last Updated: November 9, 2021
• Results First Posted: May 3, 2019

Record last verified: 2021-11

Locations

US (44)