Clinical trial NCT02969408: A Study to Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Asthma
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 (18 Years of Age or Older) With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2016-11-21
Enrollment: 397
Sex: ALL
Minimum age (years): 18
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 albuterol sulfate (ABS) eMDPI and clinical asthma exacerbation (CAE) in adult participants at least 18 years of age with exacerbation-prone asthma. The ABS eMDPI dose will be 90 micrograms (mcg), 1 to 2 inhalations every 4 hours as needed, but participant dosing will not be limited to this dosing regimen. The purpose of this study is to evaluate the relationship between albuterol dosing and CAE.


Eligibility criteria: Inclusion Criteria:

* The participant has had at least 1 episode of a severe CAE over the past 12 months before screening. If on a biologic (for example, omalizumab, mepolizumab, or reslizumab) and/or post-bronchial thermoplasty, exacerbation has occurred after these interventions.
* The participant is using a moderate-dose inhaled corticosteroid (ICS) equivalent to at least 440 mcg daily of fluticasone propionate.
* The participant's baseline asthma therapy regimen, including oral corticosteroids, leukotriene antagonists, 5-lipoxygenase inhibitors, long-acting beta agonist (LABA), long-acting muscarinic agent, or cromolyn, biologicals, theophylline, or mepolizumab, is allowed.
* 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 short-acting beta 2 agonist (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 at least 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 asthma.
* The participant has used an investigational drug within 5 half-lives of it being discontinued or 1 month of baseline visit, 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). 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 Asthma Exacerbation (CAE) Rate: Percentage of Participants Who Experienced at Least 1 Moderate or Severe CAE
timeFrame: Baseline (Day 1) to Week 12
measure: Total Number of Inhalations in the Days Preceding the Peak of a Severe CAE
timeFrame: Baseline to Week 12
measure: Number of Days Prior to the Peak of a Severe CAE When Albuterol Use Increased
timeFrame: Baseline to Week 12
measure: Number of Albuterol Uses in the 24 Hours Preceding a Severe CAE
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: Litchfield Park
country: United States
facility: Teva Investigational Site 13964
state: Arizona
city: Bakersfield
country: United States
facility: Teva Investigational Site 13959
state: California
city: Los Angeles
country: United States
facility: Teva Investigational Site 13954
state: California
city: Orange
country: United States
facility: Teva Investigational Site 13923
state: California
city: Riverside
country: United States
facility: Teva Investigational Site 13961
state: California
city: Centennial
country: United States
facility: Teva Investigational Site 13933
state: Colorado
city: Clearwater
country: United States
facility: Teva Investigational Site 13946
state: Florida
city: Loxahatchee Groves
country: United States
facility: Teva Investigational Site 13921
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 13942
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 13927
state: Florida
city: Orlando
country: United States
facility: Teva Investigational Site 13948
state: Florida
city: Orlando
country: United States
facility: Teva Investigational Site 13934
state: Florida
city: Ormond Beach
country: United States
facility: Teva Investigational Site 13931
state: Florida
city: Sarasota
country: United States
facility: Teva Investigational Site 13926
state: Florida
city: Savannah
country: United States
facility: Teva Investigational Site 13963
state: Georgia
city: Michigan City
country: United States
facility: Teva Investigational Site 13943
state: Indiana
city: Overland Park
country: United States
facility: Teva Investigational Site 13925
state: Kansas
city: Fort Mitchell
country: United States
facility: Teva Investigational Site 13958
state: Kentucky
city: Owensboro
country: United States
facility: Teva Investigational Site 13940
state: Kentucky
city: Bangor
country: United States
facility: Teva Investigational Site 13937
state: Maine
city: Saint Louis
country: United States
facility: Teva Investigational Site 13965
state: Missouri
city: Missoula
country: United States
facility: Teva Investigational Site 13919
state: Montana
city: Bellevue
country: United States
facility: Teva Investigational Site 13947
state: Nebraska
city: Brick
country: United States
facility: Teva Investigational Site 13960
state: New Jersey
city: Piscataway
country: United States
facility: Teva Investigational Site 13932
state: New Jersey
city: Verona
country: United States
facility: Teva Investigational Site 13922
state: New Jersey
city: Rochester
country: United States
facility: Teva Investigational Site 13945
state: New York
city: High Point
country: United States
facility: Teva Investigational Site 13936
state: North Carolina
city: Cincinnati
country: United States
facility: Teva Investigational Site 13953
state: Ohio
city: Edmond
country: United States
facility: Teva Investigational Site 13928
state: Oklahoma
city: Oklahoma City
country: United States
facility: Teva Investigational Site 13955
state: Oklahoma
city: East Providence
country: United States
facility: Teva Investigational Site 13949
state: Rhode Island
city: Charleston
country: United States
facility: Teva Investigational Site 13929
state: South Carolina
city: Greenville
country: United States
facility: Teva Investigational Site 13941
state: South Carolina
city: Greenville
country: United States
facility: Teva Investigational Site 13951
state: South Carolina
city: Spartanburg
country: United States
facility: Teva Investigational Site 13938
state: South Carolina
city: Knoxville
country: United States
facility: Teva Investigational Site 13924
state: Tennessee
city: Boerne
country: United States
facility: Teva Investigational Site 13962
state: Texas
city: Dallas
country: United States
facility: Teva Investigational Site 13920
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site 13930
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 13939
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 13957
state: Texas
city: South Burlington
country: United States
facility: Teva Investigational Site 13952
state: Vermont
city: Fairfax
country: United States
facility: Teva Investigational Site 13956
state: Virginia
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: