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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
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.
Age
13 - No limit years
Sex
ALL
Healthy Volunteers
No
Teva Investigational Site 14232
Birmingham, Alabama, United States
Teva Investigational Site 14302
Los Angeles, California, United States
Teva Investigational Site 14301
Stockton, California, United States
Teva Investigational Site 14236
Colorado Springs, Colorado, United States
Teva Investigational Site 14198
Denver, Colorado, United States
Teva Investigational Site 14220
New Haven, Connecticut, United States
Teva Investigational Site 14197
Aventura, Florida, United States
Teva Investigational Site 14306
Miami, Florida, United States
Teva Investigational Site 14215
Sarasota, Florida, United States
Teva Investigational Site 14304
Albany, Georgia, United States
Start Date
October 26, 2020
Primary Completion Date
October 4, 2021
Completion Date
October 4, 2021
Last Updated
March 19, 2026
333
ACTUAL participants
Albuterol eMDPI DS
DRUG
albuterol
DRUG
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
NCT07486401
NCT07219173
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT02327897