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)

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03256695
• Other study ID #: ABS-COPD-30065
• Status: Completed
• Phase: Phase 3
• Start date: September 28, 2017
• Est. completion date: April 17, 2018

Study information

• Verified date: November 2021
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 405
• Est. completion date: April 17, 2018
• Est. primary completion date: April 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Albuterol sulfate (ABS)
ABS will be administered via eMDPI as per the dose and schedule specified in the arm.

Locations

Country	Name	City	State
United States	Teva Investigational Site 14682	Andalusia	Alabama
United States	Teva Investigational Site 14704	Anniston	Alabama
United States	Teva Investigational Site 14725	Brandon	Florida
United States	Teva Investigational Site 14681	Charleston	South Carolina
United States	Teva Investigational Site 14710	Charlotte	North Carolina
United States	Teva Investigational Site 14705	Chesterfield	Missouri
United States	Teva Investigational Site 14708	Columbus	Ohio
United States	Teva Investigational Site 14703	Dayton	Ohio
United States	Teva Investigational Site 14711	Daytona Beach	Florida
United States	Teva Investigational Site 14699	DeLand	Florida
United States	Teva Investigational Site 14686	Easley	South Carolina
United States	Teva Investigational Site 14694	Edgewater	Florida
United States	Teva Investigational Site 14719	Gaffney	South Carolina
United States	Teva Investigational Site 14696	Gastonia	North Carolina
United States	Teva Investigational Site 14706	Gold River	California
United States	Teva Investigational Site 14722	Greensboro	North Carolina
United States	Teva Investigational Site 14691	Greenville	South Carolina
United States	Teva Investigational Site 14680	Grove City	Ohio
United States	Teva Investigational Site 14678	Miami	Florida
United States	Teva Investigational Site 14689	Miami	Florida
United States	Teva Investigational Site 14701	Miami	Florida
United States	Teva Investigational Site 14712	Mobile	Alabama
United States	Teva Investigational Site 14695	Mount Pleasant	South Carolina
United States	Teva Investigational Site 14677	North Dartmouth	Massachusetts
United States	Teva Investigational Site 14717	Omaha	Nebraska
United States	Teva Investigational Site 14688	Orlando	Florida
United States	Teva Investigational Site 14702	Peoria	Arizona
United States	Teva Investigational Site 14683	Pittsburgh	Pennsylvania
United States	Teva Investigational Site 14713	Richmond	Virginia
United States	Teva Investigational Site 14716	San Antonio	Texas
United States	Teva Investigational Site 14715	Spartanburg	South Carolina
United States	Teva Investigational Site 14718	Spartanburg	South Carolina
United States	Teva Investigational Site 14687	Spokane	Washington
United States	Teva Investigational Site 14709	Toledo	Ohio
United States	Teva Investigational Site 14684	Toms River	New Jersey
United States	Teva Investigational Site 14707	Union	South Carolina
United States	Teva Investigational Site 14679	Valparaiso	Indiana
United States	Teva Investigational Site 14720	Waterbury	Connecticut
United States	Teva Investigational Site 14724	Willoughby	Ohio
United States	Teva Investigational Site 14692	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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