Clinical trial NCT03256695: 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)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-22
Enrollment: 405
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Clinical Exacerbation of COPD (CE-COPD) Rate: Percentage of Participants Who Experienced at Least 1 Moderate or Severe CE-COPD
timeFrame: Baseline (Day 1) to Week 12
measure: Total Number of Albuterol Inhalations in the Days Preceding the Symptom Peak of a CE-COPD Event
timeFrame: Baseline to Week 12
measure: Number of Days Prior to the Symptom Peak of a CE-COPD Event When Albuterol Use Increased
timeFrame: Baseline to Week 12
measure: Number of Albuterol Uses in the 24 Hours Preceding a CE-COPD
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline up to Week 12
Other outcomes:
Locations:
city: Andalusia
country: United States
facility: Teva Investigational Site 14682
state: Alabama
city: Anniston
country: United States
facility: Teva Investigational Site 14704
state: Alabama
city: Mobile
country: United States
facility: Teva Investigational Site 14712
state: Alabama
city: Peoria
country: United States
facility: Teva Investigational Site 14702
state: Arizona
city: Gold River
country: United States
facility: Teva Investigational Site 14706
state: California
city: Waterbury
country: United States
facility: Teva Investigational Site 14720
state: Connecticut
city: Brandon
country: United States
facility: Teva Investigational Site 14725
state: Florida
city: Daytona Beach
country: United States
facility: Teva Investigational Site 14711
state: Florida
city: DeLand
country: United States
facility: Teva Investigational Site 14699
state: Florida
city: Edgewater
country: United States
facility: Teva Investigational Site 14694
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 14701
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 14689
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 14678
state: Florida
city: Orlando
country: United States
facility: Teva Investigational Site 14688
state: Florida
city: Valparaiso
country: United States
facility: Teva Investigational Site 14679
state: Indiana
city: North Dartmouth
country: United States
facility: Teva Investigational Site 14677
state: Massachusetts
city: Chesterfield
country: United States
facility: Teva Investigational Site 14705
state: Missouri
city: Omaha
country: United States
facility: Teva Investigational Site 14717
state: Nebraska
city: Toms River
country: United States
facility: Teva Investigational Site 14684
state: New Jersey
city: Charlotte
country: United States
facility: Teva Investigational Site 14710
state: North Carolina
city: Gastonia
country: United States
facility: Teva Investigational Site 14696
state: North Carolina
city: Greensboro
country: United States
facility: Teva Investigational Site 14722
state: North Carolina
city: Winston-Salem
country: United States
facility: Teva Investigational Site 14692
state: North Carolina
city: Columbus
country: United States
facility: Teva Investigational Site 14708
state: Ohio
city: Dayton
country: United States
facility: Teva Investigational Site 14703
state: Ohio
city: Grove City
country: United States
facility: Teva Investigational Site 14680
state: Ohio
city: Toledo
country: United States
facility: Teva Investigational Site 14709
state: Ohio
city: Willoughby
country: United States
facility: Teva Investigational Site 14724
state: Ohio
city: Pittsburgh
country: United States
facility: Teva Investigational Site 14683
state: Pennsylvania
city: Charleston
country: United States
facility: Teva Investigational Site 14681
state: South Carolina
city: Easley
country: United States
facility: Teva Investigational Site 14686
state: South Carolina
city: Gaffney
country: United States
facility: Teva Investigational Site 14719
state: South Carolina
city: Greenville
country: United States
facility: Teva Investigational Site 14691
state: South Carolina
city: Mount Pleasant
country: United States
facility: Teva Investigational Site 14695
state: South Carolina
city: Spartanburg
country: United States
facility: Teva Investigational Site 14715
state: South Carolina
city: Spartanburg
country: United States
facility: Teva Investigational Site 14718
state: South Carolina
city: Union
country: United States
facility: Teva Investigational Site 14707
state: South Carolina
city: San Antonio
country: United States
facility: Teva Investigational Site 14716
state: Texas
city: Richmond
country: United States
facility: Teva Investigational Site 14713
state: Virginia
city: Spokane
country: United States
facility: Teva Investigational Site 14687
state: Washington
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: