A 24-Week Treatment Study to Compare Standard of Care Versus the eMDPI DS in Participants 13 Years or Older With Asthma
Public ClinicalTrials.gov record NCT04677959. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
CONNected Electronic Inhalers Asthma Control Trial 2 ("CONNECT 2"), a 24-Week Treatment, Multicenter, Open-Label, Randomized, Parallel Group Comparison, Feasibility Study of Standard of Care Treatment Versus the eMDPI Digital System, to Optimize Outcomes in Patients at Least 13 Years of Age or Older With Asthma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to demonstrate the effectiveness of the Digital System (DS) in improving asthma control compared to the Standard of Care (SoC) group. The secondary objective is to describe the asthma management actions by investigational center health care providers (iHCPs) for all participants in both groups, to evaluate short-acting beta2 agonist (SABA) usage and the number of SABA-free days in the DS group, to evaluate adherence patterns to maintenance treatment (FS eMDPI) in the DS group, to assess behavioral correlates of responsiveness to digital health technology among participants for all participants in both groups, to evaluate work productivity and activity impairment in asthma participants in both groups, to assess the usability and acceptability of the DS by participants in the DS group and the investigational center personnel, and to evaluate the safety of FS eMDPI and Albuterol eMDPI.
Study identification
- NCT ID
- NCT04677959
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 427 participants
Conditions and interventions
Conditions
Interventions
- Fluticasone propionate/salmeterol (FS) Drug
- Albuterol Drug
- Standard of Care Asthma Medication Drug
- Standard of Care Rescue Medication Drug
Drug
Eligibility (public fields only)
- Age range
- 13 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 15, 2021
- Primary completion
- Mar 3, 2022
- Completion
- Mar 9, 2022
- Last update posted
- Mar 13, 2023
2021 – 2022
United States locations
- U.S. sites
- 46
- U.S. states
- 22
- U.S. cities
- 40
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Teva Investigational Site 14971 | Phoenix | Arizona | 85018 | — |
| Teva Investigational Site 14974 | Fountain Valley | California | 92708 | — |
| Teva Investigational Site 14982 | Los Angeles | California | 90025 | — |
| Teva Investigational Site 14945 | San Diego | California | 92120 | — |
| Teva Investigational Site 14946 | San Diego | California | 92123 | — |
| Teva Investigational Site 14966 | Colorado Springs | Colorado | 80907 | — |
| Teva Investigational Site 14962 | Wheat Ridge | Colorado | 80033 | — |
| Teva Investigational Site 14943 | Aventura | Florida | 33180 | — |
| Teva Investigational Site 14969 | Boynton Beach | Florida | 33472 | — |
| Teva Investigational Site 14978 | Cutler Bay | Florida | 33189 | — |
| Teva Investigational Site 14955 | Fort Lauderdale | Florida | 33308 | — |
| Teva Investigational Site 14984 | Hialeah | Florida | 33012 | — |
| Teva Investigational Site 14979 | Hialeah | Florida | 33016 | — |
| Teva Investigational Site 14953 | Miami | Florida | 33135 | — |
| Teva Investigational Site 14975 | Miami | Florida | 33166-6817 | — |
| Teva Investigational Site 14944 | Miami | Florida | 33173 | — |
| Teva Investigational Site 14970 | Miami | Florida | 33216 | — |
| Teva Investigational Site 14960 | Miami Lakes | Florida | 33014 | — |
| Teva Investigational Site 14981 | Sarasota | Florida | 34239 | — |
| Teva Investigational Site 14951 | Tallahassee | Florida | 32308-4355 | — |
| Teva Investigational Site 14942 | Savannah | Georgia | 31406 | — |
| Teva Investigational Site 14947 | Boise | Idaho | 83706 | — |
| Teva Investigational Site 14961 | Glenview | Illinois | 60026 | — |
| Teva Investigational Site 14972 | Springfield | Illinois | 62704 | — |
| Teva Investigational Site 14950 | Lexington | Kentucky | 40509 | — |
| Teva Investigational Site 14949 | Owensboro | Kentucky | 42301 | — |
| Teva Investigational Site 14976 | Bangor | Maine | 04401 | — |
| Teva Investigational Site 14983 | White Marsh | Maryland | 21162 | — |
| Teva Investigational Site 14964 | Farmington Hills | Michigan | 48336 | — |
| Teva Investigational Site 14990 | Bellevue | Nebraska | 68123-4303 | — |
| Teva Investigational Site 14977 | Lincoln | Nebraska | 68505 | — |
| Teva Investigational Site 14957 | Toms River | New Jersey | 08755 | — |
| Teva Investigational Site 14956 | Hollis | New York | 11423 | — |
| Teva Investigational Site 14954 | Gastonia | North Carolina | 28054 | — |
| Teva Investigational Site 14941 | Cincinnati | Ohio | 45221 | — |
| Teva Investigational Site 14968 | Toledo | Ohio | 43617 | — |
| Teva Investigational Site 14952 | Oklahoma City | Oklahoma | 73120 | — |
| Teva Investigational Site 14958 | Oklahoma City | Oklahoma | 73120 | — |
| Teva Investigational Site 14967 | Pittsburgh | Pennsylvania | 15241 | — |
| Teva Investigational Site 14988 | Providence | Rhode Island | 02906 | — |
| Teva Investigational Site 14989 | North Charleston | South Carolina | 29420 | — |
| Teva Investigational Site 14985 | Boerne | Texas | 78006 | — |
| Teva Investigational Site 14963 | Houston | Texas | 77081 | — |
| Teva Investigational Site 14948 | Waco | Texas | 76712 | — |
| Teva Investigational Site 14987 | Draper | Utah | 84020 | — |
| Teva Investigational Site 14965 | Murray | Utah | 84107 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04677959, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 13, 2023 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04677959 live on ClinicalTrials.gov.