At a glance
ClinicalIndex Comparison Record- ✓Age ≥13 years
- ✓Documented diagnosis of asthma
- ✓Currently on ICS/LABA maintenance therapy
- ✓Currently using albuterol as rescue medication and willing to use study-provided Albuterol eMDPI exclusively
- ✕Any clinically significant uncontrolled medical condition other than asthma
- ✕Hospitalized for severe asthma within the last 30 days
- ✕COPD or Asthma-COPD Overlap (ACO) diagnosis
- ✕Current smoker or smoking history >10 pack-years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Albuterol eMDPI DS and albuterol for Asthma. Completed, enrolled 333 participants across 29 sites.
Detailed 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.
Study Details
Timeline
Interventions
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