A 24-Week Treatment Study to Compare Standard of Care Versus the eMDPI DS in Participants 13 Years or Older With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Fluticasone propionate/salmeterol (FS); Albuterol; Standard of Care Asthma Medication; Standard of Care Rescue Medication
Intervention description: FS administered via electronic multidose dry powder inhaler (eMDPI) Digital System (DS) with component devices including smart device application (App), Digital Health Platform (DHP), and provider-facing dashboard; Albuterol administered via electronic multidose dry powder inhaler (eMDPI) Digital System (DS) with component devices including smart device application (App), Digital Health Platform (DHP), and provider-facing dashboard; Current inhaled corticosteroid(ICS)/Long-acting beta agonist(LABA) and any additional controller medication for asthma; Current rescue medication
Intervention MeSH terms: Fluticasone; Xhance; Albuterol; Salmeterol Xinafoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 427.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No

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 to describe the asthma management actions by investigational
      center health care providers (iHCPs) for all participants in both groups, to evaluate
      short-acting beta2 agonist (SABA) usage and the number of SABA-free days in the DS group, to
      evaluate adherence patterns to maintenance treatment (FS eMDPI) in the DS group, to assess
      behavioral correlates of responsiveness to digital health technology among participants for
      all participants in both groups, to evaluate work productivity and activity impairment in
      asthma participants in both groups, to assess the usability and acceptability of the DS by
      participants in the DS group and the investigational center personnel, and to evaluate the
      safety of FS eMDPI and Albuterol eMDPI.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.