A 12-Week Treatment Study to Evaluate the Effectiveness of Albuterol Multidose Dry Powder Inhaler With Integrated Electronic Module Digital System (eMDPI DS) in Participants13 Years or Older With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Albuterol eMDPI DS; albuterol
Intervention description: Albuterol sulfate electronic multidose dry powder inhaler (Albuterol eMDPI) DS with 4 component devices:
Device 1: Albuterol eMDPI
Device 2: Albuterol eMDPI Patient-facing smart device application (App)
Device 3: DHP Cloud solution)
Device 4: Provider-facing dashboard (dashboard); Standard of care albuterol-administering rescue inhaler
Intervention MeSH terms: Albuterol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 333.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No

Summary:

      This is a 12-week treatment, multicenter, open-label, randomized, parallel group comparison
      feasibility study to evaluate the effectiveness of the Albuterol eMDPI Digital System (DS),
      including inhaler, App, digital health platform (DHP) (Cloud solution), and dashboard, to
      optimize outcomes in participants at least 13 years of age or older with asthma.

      The study will consist of a screening visit, a 12-week open-label treatment period, and a
      follow-up telephone call (2 weeks following treatment completion).

      Participants with suboptimal asthma control will be enrolled in the study and randomized in a
      1:1 ratio to 1 of 2 parallel groups stratified by investigational center: DS group
      participants utilizing the Albuterol eMDPI DS, including inhaler, App, DHP (Cloud solution),
      and dashboard, and CC group participants who will be treated with their standard of care
      albuterol-administering rescue inhalers and will not use the DS during the treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant has a documented diagnosis of asthma

          -  The participant is currently on treatment with an inhaled corticosteroid (ICS) with a
             long-acting beta2 antagonist (LABA).

          -  The participant is currently using inhaled albuterol sulfate as rescue medication and
             is willing to discontinue all other rescue medications and replace them with the study
             provided Albuterol eMDPI.

          -  The participant can read and communicate in English and is familiar with and is
             willing to use his/her own smart device and download and use the App.

               -  Additional criteria apply, please contact the investigator for more information

        Exclusion Criteria:

          -  The participant has any clinically significant uncontrolled medical condition (treated
             or untreated) other than asthma.

          -  The participant was hospitalized for severe asthma in the last 30 days.

          -  The participant has a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or
             Asthma-COPD Overlap (ACO).

          -  The participant is a current smoker or has a greater than 10 pack-year history of
             smoking.

          -  The participant is currently being treated with systemic corticosteroids (oral,
             intramuscular, or intravenous) or has been treated within the last 30 days.

          -  The participant has any treatment with biologics for asthma (for example, omalizumab,
             anti-IL5, anti-IL5R, anti-IL4R), or has had such treatment within the last 90 days.

               -  Additional criteria apply, please contact the investigator for more information