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

NCT ID: NCT02969408

Last Updated: 2021-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 397 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-13
• Study Completion Date: 2018-02-02

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Albuterol Sulfate

Intervention Type: DRUG

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

Interventions

Albuterol Sulfate

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

Teva Investigational Site 13964

Litchfield Park, Arizona, United States

Teva Investigational Site 13959

Bakersfield, California, United States

Teva Investigational Site 13954

Los Angeles, California, United States

Teva Investigational Site 13923

Orange, California, United States

Teva Investigational Site 13961

Riverside, California, United States

Teva Investigational Site 13933

Centennial, Colorado, United States

Teva Investigational Site 13946

Clearwater, Florida, United States

Teva Investigational Site 13921

Loxahatchee Groves, Florida, United States

Teva Investigational Site 13942

Miami, Florida, United States

Teva Investigational Site 13927

Miami, Florida, United States

Teva Investigational Site 13948

Orlando, Florida, United States

Teva Investigational Site 13934

Orlando, Florida, United States

Teva Investigational Site 13931

Ormond Beach, Florida, United States

Teva Investigational Site 13926

Sarasota, Florida, United States

Teva Investigational Site 13963

Savannah, Georgia, United States

Teva Investigational Site 13943

Michigan City, Indiana, United States

Teva Investigational Site 13925

Overland Park, Kansas, United States

Teva Investigational Site 13958

Fort Mitchell, Kentucky, United States

Teva Investigational Site 13940

Owensboro, Kentucky, United States

Teva Investigational Site 13937

Bangor, Maine, United States

Teva Investigational Site 13965

St Louis, Missouri, United States

Teva Investigational Site 13919

Missoula, Montana, United States

Teva Investigational Site 13947

Bellevue, Nebraska, United States

Teva Investigational Site 13960

Brick, New Jersey, United States

Teva Investigational Site 13932

Piscataway, New Jersey, United States

Teva Investigational Site 13922

Verona, New Jersey, United States

Teva Investigational Site 13945

Rochester, New York, United States

Teva Investigational Site 13936

High Point, North Carolina, United States

Teva Investigational Site 13953

Cincinnati, Ohio, United States

Teva Investigational Site 13928

Edmond, Oklahoma, United States

Teva Investigational Site 13955

Oklahoma City, Oklahoma, United States

Teva Investigational Site 13949

East Providence, Rhode Island, United States

Teva Investigational Site 13929

Charleston, South Carolina, United States

Teva Investigational Site 13941

Greenville, South Carolina, United States

Teva Investigational Site 13951

Greenville, South Carolina, United States

Teva Investigational Site 13938

Spartanburg, South Carolina, United States

Teva Investigational Site 13924

Knoxville, Tennessee, United States

Teva Investigational Site 13962

Boerne, Texas, United States

Teva Investigational Site 13920

Dallas, Texas, United States

Teva Investigational Site 13930

Houston, Texas, United States

Teva Investigational Site 13939

San Antonio, Texas, United States

Teva Investigational Site 13957

San Antonio, Texas, United States

Teva Investigational Site 13952

South Burlington, Vermont, United States

Teva Investigational Site 13956

Fairfax, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ABS-AS-30064

Identifier Type: -

Identifier Source: org_study_id