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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: Completed Phase 4 study, sponsored by GlaxoSmithKline.
NCT03380429 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 437 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Daily adherence is defined as the participant taking one dose of Relvar/Breo ELLIPTA, within a 24-hour period, starting at 12.00 anti-meridiem (a.m.) each day of the treatment period. The percentage of ELLIPTA doses taken were determined by the clip-on sensor attached to ELLIPTA, which records the time and date when the ELLIPTA cover was opened and closed. Analysis was carried out by Analysis of Covariance (ANCOVA) model. Least Square mean percentage of ELLIPTA doses taken (daily adherence) betw
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 |
What the finished NCT03380429 record still lists
NCT03380429 is an interventional study that assigns participants to a tested intervention. The registered 437 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (16% lower).
The record links to 0 conditions, and to 5 interventions - of which Salbutamol is the first listed.
NCT03380429 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03380429's enrollment target sits among peer trials
437 191st of 2000 higher than 1,809 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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