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COMPLETED Phase 4

A 24-Week Treatment Study to Compare Standard of Care Versus the eMDPI DS in Participants 13 Years or Older With Asthma

NCT04677959 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 427 participants
Start Date 2021-02-16
Est. Completion 2022-03-10
Phase Phase 4

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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. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 427 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 103 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04677959 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Florida, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04677959?

This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 103 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial