A Study to Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Asthma

Asthma 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 (18 Years of Age or Older) With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02969408
• Other study ID #: ABS-AS-30064
• Status: Completed
• Phase: Phase 3
• Start date: February 13, 2017
• Est. completion date: February 2, 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 397
• Est. completion date: February 2, 2018
• Est. primary completion date: February 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Albuterol Sulfate
Albuterol sulfate will be administered as per the dose and schedule specified in the arm.

Locations

Country	Name	City	State
United States	Teva Investigational Site 13959	Bakersfield	California
United States	Teva Investigational Site 13937	Bangor	Maine
United States	Teva Investigational Site 13947	Bellevue	Nebraska
United States	Teva Investigational Site 13962	Boerne	Texas
United States	Teva Investigational Site 13960	Brick	New Jersey
United States	Teva Investigational Site 13933	Centennial	Colorado
United States	Teva Investigational Site 13929	Charleston	South Carolina
United States	Teva Investigational Site 13953	Cincinnati	Ohio
United States	Teva Investigational Site 13946	Clearwater	Florida
United States	Teva Investigational Site 13920	Dallas	Texas
United States	Teva Investigational Site 13949	East Providence	Rhode Island
United States	Teva Investigational Site 13928	Edmond	Oklahoma
United States	Teva Investigational Site 13956	Fairfax	Virginia
United States	Teva Investigational Site 13958	Fort Mitchell	Kentucky
United States	Teva Investigational Site 13941	Greenville	South Carolina
United States	Teva Investigational Site 13951	Greenville	South Carolina
United States	Teva Investigational Site 13936	High Point	North Carolina
United States	Teva Investigational Site 13930	Houston	Texas
United States	Teva Investigational Site 13924	Knoxville	Tennessee
United States	Teva Investigational Site 13964	Litchfield Park	Arizona
United States	Teva Investigational Site 13954	Los Angeles	California
United States	Teva Investigational Site 13921	Loxahatchee Groves	Florida
United States	Teva Investigational Site 13927	Miami	Florida
United States	Teva Investigational Site 13942	Miami	Florida
United States	Teva Investigational Site 13943	Michigan City	Indiana
United States	Teva Investigational Site 13919	Missoula	Montana
United States	Teva Investigational Site 13955	Oklahoma City	Oklahoma
United States	Teva Investigational Site 13923	Orange	California
United States	Teva Investigational Site 13934	Orlando	Florida
United States	Teva Investigational Site 13948	Orlando	Florida
United States	Teva Investigational Site 13931	Ormond Beach	Florida
United States	Teva Investigational Site 13925	Overland Park	Kansas
United States	Teva Investigational Site 13940	Owensboro	Kentucky
United States	Teva Investigational Site 13932	Piscataway	New Jersey
United States	Teva Investigational Site 13961	Riverside	California
United States	Teva Investigational Site 13945	Rochester	New York
United States	Teva Investigational Site 13965	Saint Louis	Missouri
United States	Teva Investigational Site 13939	San Antonio	Texas
United States	Teva Investigational Site 13957	San Antonio	Texas
United States	Teva Investigational Site 13926	Sarasota	Florida
United States	Teva Investigational Site 13963	Savannah	Georgia
United States	Teva Investigational Site 13952	South Burlington	Vermont
United States	Teva Investigational Site 13938	Spartanburg	South Carolina
United States	Teva Investigational Site 13922	Verona	New Jersey

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 Asthma Exacerbation (CAE) Rate: Percentage of Participants Who Experienced at Least 1 Moderate or Severe CAE	CAE was an occurrence of either severe CAE or moderate CAE. Severe CAE was defined as a CAE that involved worsening asthma such that the treating physician elected to administer prednisone (or equivalent glucocorticoid treatment) at least 10 milligrams (mg) prednisone equivalent above Baseline, for at least 3 days; and an unscheduled provider visit such as an office visit, urgent care visit, emergency care visit, or hospitalization.; Moderate CAE was defined as a CAE that involved worsening asthma such that the treating physician elected to administer prednisone (or equivalent glucocorticoid treatment) at least 10 mg prednisone equivalent above Baseline, for at least 3 days, or an unscheduled provider visit such as an office visit, urgent care visit, emergency care visit, or hospitalization associated with an increase in asthma therapy that did not qualify for severe CAE as defined above.	Baseline (Day 1) to Week 12
Primary	Total Number of Inhalations in the Days Preceding the Peak of a Severe CAE	Severe CAE was defined as a CAE that involved worsening asthma such that the treating physician elected to administer prednisone (or equivalent glucocorticoid treatment) at least 10 mg prednisone equivalent above Baseline, for at least 3 days; and an unscheduled provider visit such as an office visit, urgent care visit, emergency care visit, or hospitalization. Total number of inhalations taken in 1 day (that is, the 24-hour period on the day prior to the date of the CAE symptom peak) and at 3, 5, 7, 10, 14, and 21 days preceding the date of the severe CAE symptom peak were reported.	Baseline to Week 12
Primary	Number of Days Prior to the Peak of a Severe CAE When Albuterol Use Increased	Severe CAE was defined as a CAE that involved worsening asthma such that the treating physician elected to administer prednisone (or equivalent glucocorticoid treatment) at least 10 mg prednisone equivalent above Baseline, for at least 3 days; and an unscheduled provider visit such as an office visit, urgent care visit, emergency care visit, or hospitalization. Number of days prior to the peak of a severe CAE when albuterol use first increased to greater than (>) 4, >12, and >20 inhalations was reported. Participants were counted in more than 1 category (that is, all of the >20 inhalation participants were also counted in the >12 category, and in the >4 category).	Baseline to Week 12
Primary	Number of Albuterol Uses in the 24 Hours Preceding a Severe CAE	Severe CAE was defined as a CAE that involved worsening asthma such that the treating physician elected to administer prednisone (or equivalent glucocorticoid treatment) at least 10 mg prednisone equivalent above Baseline, for at least 3 days; and an unscheduled provider visit such as an office visit, urgent care visit, emergency care visit, or hospitalization. Number of albuterol inhalations used in the 24 hours preceeding a severe CAE is 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