Study ID: ABS-AS-40138
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 Range
- 13 Years and older
Trial Duration
- October 26, 2020 - October 4, 2021
Phase
- Phase 4
Additional info
Study Type
Interventional
