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NCT04677959 · ClinicalTrials.gov registry record · Phase 4
A 24-Week Treatment Study to Compare Standard of Care Versus the eMDPI DS in Participants 13 Years or Older With Asthma
A Phase 4 study of Asthma, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 4
- Development phase
- 427
- Enrollment target
- 20
- Study locations
NCT04677959 is a Phase 4 study of Asthma that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 427 participants, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 4 states.
The verdict
NCT04677959, a Phase 4 study of Asthma, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 427 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Albuterol
- DRUG Fluticasone propionate/salmeterol (FS)
- DRUG Standard of Care Asthma Medication
- DRUG Standard of Care Rescue Medication
Study Locations (20)
Florida
- Teva Investigational Site 14943 - Aventura
- Teva Investigational Site 14969 - Boynton Beach
- Teva Investigational Site 14978 - Cutler Bay
- Teva Investigational Site 14955 - Fort Lauderdale
- Teva Investigational Site 14984 - Hialeah
- Teva Investigational Site 14979 - Hialeah
- Teva Investigational Site 14953 - Miami
- Teva Investigational Site 14975 - Miami
- Teva Investigational Site 14944 - Miami
- Teva Investigational Site 14970 - Miami
- Teva Investigational Site 14960 - Miami Lakes
- Teva Investigational Site 14981 - Sarasota
- Teva Investigational Site 14951 - Tallahassee
California
- Teva Investigational Site 14974 - Fountain Valley
- Teva Investigational Site 14982 - Los Angeles
- Teva Investigational Site 14945 - San Diego
- Teva Investigational Site 14946 - San Diego
Colorado
- Teva Investigational Site 14966 - Colorado Springs
- Teva Investigational Site 14962 - Wheat Ridge
Arizona
- Teva Investigational Site 14971 - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 427 participants |
| Start Date | 2021-02-16 |
| Est. Completion | 2022-03-10 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04677959
The ClinicalTrials.gov registry entry for NCT04677959 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 427 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (73% lower). The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 167 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 4 interventions - of which Albuterol is the first listed.
NCT04677959 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT04677959 about?
NCT04677959 is a clinical study titled "A 24-Week Treatment Study to Compare Standard of Care Versus the eMDPI DS in Participants 13 Years or Older With Asthma". 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) f...
What is the current status of trial NCT04677959?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 427 participants. The study started on 2021-02-16. Estimated completion is 2022-03-10.
What conditions does trial NCT04677959 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT04677959?
The interventions under investigation include: Albuterol (DRUG), Fluticasone propionate/salmeterol (FS) (DRUG), Standard of Care Asthma Medication (DRUG), Standard of Care Rescue Medication (DRUG).
Who is sponsoring clinical trial NCT04677959?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04677959 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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