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)

NCT03256695 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ABS-COPD-30065
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 40

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

Outcome Measures

Primary Outcomes (4)

• Clinical Exacerbation of COPD (CE-COPD) Rate: Percentage of Participants Who Experienced at Least 1 Moderate or Severe CE-COPD

  CE-COPD was an occurrence of either severe CE-COPD or moderate CE-COPD. Severe CE-COPD was defined as an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with systemic corticosteroids (SCS; at least 10 milligrams \[mg\] prednisone equivalent above baseline) and/or systemic antibiotics and a hospitalization for CE COPD. Moderate CE-COPD was defined as an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline), and/or systemic antibiotics, and an unscheduled encounter (such as a phone call, an office visit, an urgent care visit, or an emergency care visit) for a CE-COPD, but not a hospitalization.

  Baseline (Day 1) to Week 12

• Total Number of Albuterol Inhalations in the Days Preceding the Symptom Peak of a CE-COPD Event

  Severe CE-COPD: an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline) and/or systemic antibiotics and a hospitalization. Moderate CE-COPD: an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline), and/or systemic antibiotics, and an unscheduled encounter (such as a phone call, office visit, urgent care visit, or emergency care visit), but not a hospitalization. Total number of inhalations taken in 1 day(24-hour period on day prior to date of CE-COPD symptom peak) and at 3,5,7,10,14, and 21 days preceding the date of CE-COPD symptom peak were reported. If a participant experienced multiple CE-COPD events, number of inhalations preceding symptom peak of a subsequent event was counted since end of previous event. Average of inhalations of all events were presented.

  Baseline to Week 12

• Number of Days Prior to the Symptom Peak of a CE-COPD Event When Albuterol Use Increased

  CE-COPD: occurrence of moderate or severe CE-COPD. Severe CE-COPD: an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline) and/or systemic antibiotics and a hospitalization. Moderate CE-COPD: an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline), and/or systemic antibiotics, and an unscheduled encounter (such as a phone call, an office visit, an urgent care visit, or an emergency care visit), but not a hospitalization. Number of days of increased albuterol use prior to the symptom peak of a CE-COPD was reported for first increase of daily albuterol use; 2 and 4 inhalations in a single day from baseline. increased daily albuterol use was defined as single-day increase of greater than (\>) 20 percent (%) from baseline.

  Baseline to Week 12

• Number of Albuterol Uses in the 24 Hours Preceding a CE-COPD

  CE-COPD referred to occurrence of moderate or severe CE-COPD. Severe CE-COPD was defined as an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline) and/or systemic antibiotics and a hospitalization for CE COPD. Moderate CE-COPD was defined as an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline), and/or systemic antibiotics, and an unscheduled encounter (such as a phone call, an office visit, an urgent care visit, or an emergency care visit) for a CE-COPD, but not a hospitalization. Number of albuterol inhalations used in the 24 hours preceding a moderate or severe CE-COPD was 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 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.

Drug: Albuterol sulfate (ABS)

Interventions

Albuterol sulfate (ABS) DRUG

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

ABS eMDPI

Eligibility Criteria

• Age: 40 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 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.

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 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 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 (40)

Teva Investigational Site 14682

Andalusia, Alabama, 36420, United States

Location

Teva Investigational Site 14704

Anniston, Alabama, 36207, United States

Location

Teva Investigational Site 14712

Mobile, Alabama, 36608, United States

Location

Teva Investigational Site 14702

Peoria, Arizona, 85381, United States

Location

Teva Investigational Site 14706

Gold River, California, 95670, United States

Location

Teva Investigational Site 14720

Waterbury, Connecticut, 06708, United States

Location

Teva Investigational Site 14725

Brandon, Florida, 33511, United States

Location

Teva Investigational Site 14711

Daytona Beach, Florida, 32117, United States

Location

Teva Investigational Site 14699

DeLand, Florida, 32720, United States

Location

Teva Investigational Site 14694

Edgewater, Florida, 32132, United States

Location

Teva Investigational Site 14701

Miami, Florida, 33126, United States

Location

Teva Investigational Site 14689

Miami, Florida, 33135, United States

Location

Teva Investigational Site 14678

Miami, Florida, 33155, United States

Location

Teva Investigational Site 14688

Orlando, Florida, 32825, United States

Location

Teva Investigational Site 14679

Valparaiso, Indiana, 46383, United States

Location

Teva Investigational Site 14677

North Dartmouth, Massachusetts, 02747, United States

Location

Teva Investigational Site 14705

Chesterfield, Missouri, 63017, United States

Location

Teva Investigational Site 14717

Omaha, Nebraska, 68114, United States

Location

Teva Investigational Site 14684

Toms River, New Jersey, 08755, United States

Location

Teva Investigational Site 14710

Charlotte, North Carolina, 28207, United States

Location

Teva Investigational Site 14696

Gastonia, North Carolina, 28054, United States

Location

Teva Investigational Site 14722

Greensboro, North Carolina, 27408, United States

Location

Teva Investigational Site 14692

Winston-Salem, North Carolina, 27103, United States

Location

Teva Investigational Site 14708

Columbus, Ohio, 43215, United States

Location

Teva Investigational Site 14703

Dayton, Ohio, 45458, United States

Location

Teva Investigational Site 14680

Grove City, Ohio, 43123, United States

Location

Teva Investigational Site 14709

Toledo, Ohio, 43617, United States

Location

Teva Investigational Site 14724

Willoughby, Ohio, 44094, United States

Location

Teva Investigational Site 14683

Pittsburgh, Pennsylvania, 15243, United States

Location

Teva Investigational Site 14681

Charleston, South Carolina, 29406, United States

Location

Teva Investigational Site 14686

Easley, South Carolina, 29640, United States

Location

Teva Investigational Site 14719

Gaffney, South Carolina, 29341, United States

Location

Teva Investigational Site 14691

Greenville, South Carolina, 29615, United States

Location

Teva Investigational Site 14695

Mt. Pleasant, South Carolina, 29464, United States

Location

Teva Investigational Site 14715

Spartanburg, South Carolina, 29303, United States

Location

Teva Investigational Site 14718

Spartanburg, South Carolina, 29303, United States

Location

Teva Investigational Site 14707

Union, South Carolina, 29379, United States

Location

Teva Investigational Site 14716

San Antonio, Texas, 78229, United States

Location

Teva Investigational Site 14713

Richmond, Virginia, 23225, United States

Location

Teva Investigational Site 14687

Spokane, Washington, 99204, United States

Location

Related Publications (1)

• 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.

  PMID: 40355297 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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.

USMedInfo@tevapharm.com

1-888-483-8279

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: August 18, 2017
• First Posted: August 22, 2017
• Study Start: September 28, 2017
• Primary Completion: April 17, 2018
• Study Completion: April 17, 2018
• Last Updated: November 9, 2021
• Results First Posted: August 6, 2019

Record last verified: 2021-11

Locations

US (40)