Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT03256695

Last Updated: 2021-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 405 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-28
• Study Completion Date: 2018-04-17

Brief Summary

This is a Phase 3B, 12-week, multicenter, open-label study to evaluate the relationship between as-needed usage of albuterol eMDPI and Clinical Exacerbation-Chronic Obstructive Pulmonary Disease (CE-COPD) in adult participants at least 40 years of age with exacerbation-prone COPD.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

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

Study Groups

ABS eMDPI

Participants will receive 90 micrograms (mcg) of albuterol sulfate (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 is a rescue/reliever agent that includes an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants will be allowed to continue use of other COPD and non-COPD medications as advised by their physician without changes unless deemed necessary by their physician.

Group Type: EXPERIMENTAL

Albuterol sulfate (ABS)

Intervention Type: DRUG

ABS will be administered via eMDPI as per the dose and schedule specified in the arm.

Interventions

Albuterol sulfate (ABS)

ABS will be administered via eMDPI 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 moderate or severe CE-COPD over the past 12 months before screening.
• The participant must be able to demonstrate appropriate use of albuterol from the ABS eMDPI.
• The participant is currently using a short-acting beta agonist (SABA) reliever plus at least one of the following: long-acting beta agonist (LABA), an inhaled corticosteroid (ICS)/LABA, a long-acting muscarinic antagonist (LAMA), or a LABA/LAMA.
• 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 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 greater than or equal to [≥]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 COPD.
• The participant has used an investigational drug within 5 half-lives of it being discontinued or within1 month of Visit 2 (Baseline [Day 1]), 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 [milk protein]). 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: 40 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 14682

Andalusia, Alabama, United States

Teva Investigational Site 14704

Anniston, Alabama, United States

Teva Investigational Site 14712

Mobile, Alabama, United States

Teva Investigational Site 14702

Peoria, Arizona, United States

Teva Investigational Site 14706

Gold River, California, United States

Teva Investigational Site 14720

Waterbury, Connecticut, United States

Teva Investigational Site 14725

Brandon, Florida, United States

Teva Investigational Site 14711

Daytona Beach, Florida, United States

Teva Investigational Site 14699

DeLand, Florida, United States

Teva Investigational Site 14694

Edgewater, Florida, United States

Teva Investigational Site 14701

Miami, Florida, United States

Teva Investigational Site 14689

Miami, Florida, United States

Teva Investigational Site 14678

Miami, Florida, United States

Teva Investigational Site 14688

Orlando, Florida, United States

Teva Investigational Site 14679

Valparaiso, Indiana, United States

Teva Investigational Site 14677

North Dartmouth, Massachusetts, United States

Teva Investigational Site 14705

Chesterfield, Missouri, United States

Teva Investigational Site 14717

Omaha, Nebraska, United States

Teva Investigational Site 14684

Toms River, New Jersey, United States

Teva Investigational Site 14710

Charlotte, North Carolina, United States

Teva Investigational Site 14696

Gastonia, North Carolina, United States

Teva Investigational Site 14722

Greensboro, North Carolina, United States

Teva Investigational Site 14692

Winston-Salem, North Carolina, United States

Teva Investigational Site 14708

Columbus, Ohio, United States

Teva Investigational Site 14703

Dayton, Ohio, United States

Teva Investigational Site 14680

Grove City, Ohio, United States

Teva Investigational Site 14709

Toledo, Ohio, United States

Teva Investigational Site 14724

Willoughby, Ohio, United States

Teva Investigational Site 14683

Pittsburgh, Pennsylvania, United States

Teva Investigational Site 14681

Charleston, South Carolina, United States

Teva Investigational Site 14686

Easley, South Carolina, United States

Teva Investigational Site 14719

Gaffney, South Carolina, United States

Teva Investigational Site 14691

Greenville, South Carolina, United States

Teva Investigational Site 14695

Mt. Pleasant, South Carolina, United States

Teva Investigational Site 14715

Spartanburg, South Carolina, United States

Teva Investigational Site 14718

Spartanburg, South Carolina, United States

Teva Investigational Site 14707

Union, South Carolina, United States

Teva Investigational Site 14716

San Antonio, Texas, United States

Teva Investigational Site 14713

Richmond, Virginia, United States

Teva Investigational Site 14687

Spokane, Washington, United States

Countries

United States

References

Snyder LD, DePietro M, Reich M, Neely ML, Lugogo N, Pleasants R, Li T, Granovsky L, Brown R, Safioti G. Predictive machine learning algorithm for COPD exacerbations using a digital inhaler with integrated sensors. BMJ Open Respir Res. 2025 May 12;12(1):e002577. doi: 10.1136/bmjresp-2024-002577.

Reference Type: DERIVED

PMID: 40355297 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ABS-COPD-30065

Identifier Type: -

Identifier Source: org_study_id