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

• Status: Completed
• Trial end date: 2021-10-04
• Target enrollment: 0
• Participant gender: All

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, 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 call (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 parallel 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Branded Pharmaceutical Products, R&D Inc.
• Treatments: Albuterol

Criteria

Inclusion Criteria:

• The patient has a documented diagnosis of asthma

• The patient is currently on treatment with an inhaled corticosteroid (ICS) with a long-acting beta2 antagonist (LABA).

• The patient 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 multidose dry powder inhaler with integrated electronic module (eMDPI).

• The patient 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 patient has any clinically significant uncontrolled medical condition (treated or untreated) other than asthma.

• The patient was hospitalized for severe asthma in the last 30 days.

• The patient has a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or Asthma-COPD Overlap (ACO).

• The patient is a current smoker or has a greater than 10 pack-year history of smoking.

• The patient is currently being treated with systemic corticosteroids (oral, intramuscular, or intravenous) or has been treated within the last 30 days.

• The patient has any treatment with biologics for asthma (eg, 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