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)

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 (40 Years of Age or Older) With Chronic Obstructive Pulmonary Disease

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Albuterol sulfate (ABS)

• Study Type: Interventional
• Enrollment (Actual): 405
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Andalusia, Alabama, United States, 36420
      • Teva Investigational Site 14682
    • Anniston, Alabama, United States, 36207
      • Teva Investigational Site 14704
    • Mobile, Alabama, United States, 36608
      • Teva Investigational Site 14712
  • Arizona
    • Peoria, Arizona, United States, 85381
      • Teva Investigational Site 14702
  • California
    • Gold River, California, United States, 95670
      • Teva Investigational Site 14706
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Teva Investigational Site 14720
  • Florida
    • Brandon, Florida, United States, 33511
      • Teva Investigational Site 14725
    • Daytona Beach, Florida, United States, 32117
      • Teva Investigational Site 14711
    • DeLand, Florida, United States, 32720
      • Teva Investigational Site 14699
    • Edgewater, Florida, United States, 32132
      • Teva Investigational Site 14694
    • Miami, Florida, United States, 33126
      • Teva Investigational Site 14701
    • Miami, Florida, United States, 33135
      • Teva Investigational Site 14689
    • Miami, Florida, United States, 33155
      • Teva Investigational Site 14678
    • Orlando, Florida, United States, 32825
      • Teva Investigational Site 14688
  • Indiana
    • Valparaiso, Indiana, United States, 46383
      • Teva Investigational Site 14679
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
      • Teva Investigational Site 14677
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Teva Investigational Site 14705
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Teva Investigational Site 14717
  • New Jersey
    • Toms River, New Jersey, United States, 08755
      • Teva Investigational Site 14684
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Teva Investigational Site 14710
    • Gastonia, North Carolina, United States, 28054
      • Teva Investigational Site 14696
    • Greensboro, North Carolina, United States, 27408
      • Teva Investigational Site 14722
    • Winston-Salem, North Carolina, United States, 27103
      • Teva Investigational Site 14692
  • Ohio
    • Columbus, Ohio, United States, 43215
      • Teva Investigational Site 14708
    • Dayton, Ohio, United States, 45458
      • Teva Investigational Site 14703
    • Grove City, Ohio, United States, 43123
      • Teva Investigational Site 14680
    • Toledo, Ohio, United States, 43617
      • Teva Investigational Site 14709
    • Willoughby, Ohio, United States, 44094
      • Teva Investigational Site 14724
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15243
      • Teva Investigational Site 14683
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Teva Investigational Site 14681
    • Easley, South Carolina, United States, 29640
      • Teva Investigational Site 14686
    • Gaffney, South Carolina, United States, 29341
      • Teva Investigational Site 14719
    • Greenville, South Carolina, United States, 29615
      • Teva Investigational Site 14691
    • Mount Pleasant, South Carolina, United States, 29464
      • Teva Investigational Site 14695
    • Spartanburg, South Carolina, United States, 29303
      • Teva Investigational Site 14715
    • Spartanburg, South Carolina, United States, 29303
      • Teva Investigational Site 14718
    • Union, South Carolina, United States, 29379
      • Teva Investigational Site 14707
  • Texas
    • San Antonio, Texas, United States, 78229
      • Teva Investigational Site 14716
  • Virginia
    • Richmond, Virginia, United States, 23225
      • Teva Investigational Site 14713
  • Washington
    • Spokane, Washington, United States, 99204
      • Teva Investigational Site 14687

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 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 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.

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 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); ABS will be administered via eMDPI 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 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 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): September 28, 2017
• Primary Completion (Actual): April 17, 2018
• Study Completion (Actual): April 17, 2018

Study Registration Dates

• First Submitted: August 18, 2017
• First Submitted That Met QC Criteria: August 18, 2017
• First Posted (Actual): August 22, 2017

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; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; 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-COPD-30065

Drug and device information, study documents

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