Status:
COMPLETED
A 24-Week Treatment Study to Compare Standard of Care Versus the eMDPI DS in Participants 13 Years or Older With Asthma
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Asthma
Eligibility:
All Genders
13+ years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to demonstrate the effectiveness of the Digital System (DS) in improving asthma control compared to the Standard of Care (SoC) group. The secondary objective is...
Detailed Description
Study duration will be approximately 27 weeks including a one-week screening period, 24 week treatment period, and a 2 week follow-up period.
Eligibility Criteria
Inclusion
- The participant has a documented diagnosis of asthma established at the investigational center at the time of informed consent or the investigator confirms a diagnosis of asthma.
- The participant is currently on treatment with a moderate- to high-dose inhaled corticosteroid (ICS) with long-acting beta agonist (LABA).
- The participant has an Asthma Control Test score of less than 19 at the screening or baseline visit.
- The participant is willing to discontinue all other maintenance ICS with LABA medications and rescue medications and replace them with the study-provided fluticasone propionate/salmeterol (FS) multidose dry powder inhaler with integrated electronic module (eMDPI) and Albuterol eMDPI, respectively, for the duration of the trial, if randomized to the Digital System group. All other asthma maintenance medications, except for ICS with LABA, may be continued.
- Additional criteria apply, please contact the investigator for more information.
Exclusion
- The participant is currently being treated prior to enrollment with a digital inhaler system, including the Digihaler system or an external "bolt on" digital system designed to monitor inhaler usage, such as the Propeller Health or Adherium systems.
- The participant has any clinically significant uncontrolled medical condition (treated or untreated) other than asthma, which in the view of the investigator would preclude participation.
- The participant was hospitalized for severe asthma in the last 30 days.
- The participant has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the patient's ability to participate in this study.
- Additional criteria apply, please contact the investigator for more information.
Key Trial Info
Start Date :
February 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2022
Estimated Enrollment :
427 Patients enrolled
Trial Details
Trial ID
NCT04677959
Start Date
February 16 2021
End Date
March 10 2022
Last Update
March 14 2023
Active Locations (46)
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1
Teva Investigational Site 14971
Phoenix, Arizona, United States, 85018
2
Teva Investigational Site 14974
Fountain Valley, California, United States, 92708
3
Teva Investigational Site 14982
Los Angeles, California, United States, 90025
4
Teva Investigational Site 14945
San Diego, California, United States, 92120