NCT03890666

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

CONNected Electronic Inhalers Asthma Control Trial 1 ("CONNECT 1"), a 12-Week Treatment, Multicenter, Open-Label, Randomized, Parallel Group Comparison, Feasibility Study to Evaluate the Effectiveness of the Albuterol eMDPI Digital System, to Optimize Outcomes in Patients at Least 13 Years of Age or Older With Asthma

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 333 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Albuterol eMDPI DS	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)
DRUG	albuterol	Standard of care albuterol-administering rescue inhaler

Timeline

• Start date: 2020-10-26
• Primary completion: 2021-10-04
• Completion: 2021-10-04
• First posted: 2019-03-26
• Last updated: 2026-03-19
• Results posted: 2022-10-27

Locations

29 sites across 1 country: United States

Regulatory

• FDA-regulated drug study