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NCT03380429 · ClinicalTrials.gov registry record · Phase 4
A Clinical Study to Evaluate the Effect of the Connected Inhaler System (CIS) on Adherence to Maintenance Therapy in Poorly Controlled Asthmatic Subjects
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 437
- Enrollment target
NCT03380429 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 437 participants.
The verdict
NCT03380429, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 437 participants
- Enrollment target
Study Summary
GlaxoSmithKline (GSK) in collaboration with Propeller Health has developed a sensor, which can clip on to the ELLIPTA® dry powder inhaler (DPI) and monitor the time and date that the ELLIPTA DPI cover is fully opened and closed. Additionally, a sensor will be attached to the rescue medication metered dose inhaler (MDI). The data from both sensors will be fed back to the subject via an application (app) on smart phone and will be reviewed by the subject's health care professional (HCP) via an online dashboard. The sensors, app, dashboard and systems to provide data comprise the CIS. This study will be the first to evaluate the effect of CIS on adherence to maintenance therapy in subjects with uncontrolled asthma. This is an open-label, randomized, parallel group study in asthmatic subjects currently on a fixed dose inhaled corticosteroid (ICS)/long-acting beta 2 agonist (LABA) maintenance therapy. Eligible subjects will receive RELVAR®/BREO® maintenance therapy via ELLIPTA DPI and salbutamol rescue medication via MDI with sensors attached to both inhalers during the run-in period, which may last for up to 3 months. Eligible subjects will then be randomized into five treatment arms depending on whether the data, from RELVAR/BREO ELLIPTA or RELVAR/BREO ELLIPTA and salbutamol MDI, is fed back to the subject or subject and HCP, or not at all. The treatment period for the study is approximately 6 months and there will be a follow-up period one week post last visit. The total duration of a subject in the study will be approximately 9 months. RELVAR, BREO and ELLIPTA are registered trademarks of GlaxoSmithKline group of companies.
Interventions
- DRUG Salbutamol
- DRUG RELVAR/BREO
- DEVICE Smart phone app
- DEVICE HCP Dashboard
- DEVICE Sensors
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 437 participants |
| Start Date | 2018-01-31 |
| Est. Completion | 2019-01-24 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03380429
The ClinicalTrials.gov registry entry for NCT03380429 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 437 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Salbutamol is the first listed.
NCT03380429 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03380429 about?
NCT03380429 is a clinical study titled "A Clinical Study to Evaluate the Effect of the Connected Inhaler System (CIS) on Adherence to Maintenance Therapy in Poorly Controlled Asthmatic Subjects". GlaxoSmithKline (GSK) in collaboration with Propeller Health has developed a sensor, which can clip on to the ELLIPTA® dry powder inhaler (DPI) and monitor the time and date that the ELLIPTA DPI cover is fully opened and closed. Additionally, a sensor will be attached to the rescue medication metere...
What is the current status of trial NCT03380429?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 437 participants. The study started on 2018-01-31. Estimated completion is 2019-01-24.
What interventions are being tested in trial NCT03380429?
The interventions under investigation include: Salbutamol (DRUG), RELVAR/BREO (DRUG), Smart phone app (DEVICE), HCP Dashboard (DEVICE), Sensors (DEVICE).
Who is sponsoring clinical trial NCT03380429?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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