Effectiveness of Albuterol Inhaler With Integrated Electronic Module Digital System
- Study Title
- A 12-Week Treatment Study to Evaluate the Effectiveness of Albuterol Multidose Dry Powder Inhaler With Integrated Electronic Module Digital System (eMDPI DS) in Patients 13 Years or Older With Asthma
- Teva Identifier
- ABS-AS-40138
- ClinicalTrials.gov Identifier
- NCT03890666
- Study Status
- Completed
- Trial Condition(s)
- Asthma
- Interventions
- Drug: Albuterol eMDPI DS | Drug: albuterol
- Study Description
- This is a 12-week treatment, multicenter, open-label, randomized, parFemale, Maleel group comparison feasibility study to evaluate the effectiveness of the Albuterol eMDPI Digital System (DS), including inhaler, App, DHP (Cloud solution), and dashboard, to optimize outcomes in patients 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 cFemale, Male (2 weeks following treatment completion). Patients with suboptimal asthma control will be enrolled in the study and randomized in a 1:1 ratio to 1 of 2 parFemale, Maleel groups stratified by investigational center: DS group patients utilizing the Albuterol eMDPI DS, including inhaler, App, DHP (Cloud solution), and dashboard, and CC group patients who will be treated with their standard of care albuterol-administering rescue inhalers and will not use the DS during the treatment period.
Key Participation Requirements
- Gender
- Female, Male
- Age group
- Child, Adult, Older Adult
- Age Range
- 13 Years and older
- Trial Duration
- October 26, 2020 - October 4, 2021
- Phase
- Phase 4
