CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 111 enrolled
Drug / intervention
SERETIDE MDI +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02416180
NCT02416180Phase 4Completed

An Open-label Study Investigating Critical and Overall Errors Following 14 Days of Treatment With SERETIDE Metered Dose Inhaler (EVOHALER) in Adult Subjects With Controlled Asthma Currently Using the SERETIDE DISKUS Inhaler

GlaxoSmithKline·interventional·Posted Apr 14, 2015·Updated May 30, 2017

In Brief

A Phase 4 clinical trial evaluating SERETIDE MDI, Placebo DISKUS Inhaler, and 1 other intervention for Asthma. Completed, enrolled 111 participants across 7 sites.

Detailed Summary

This study aims to explore the potential impact of switching inhalers by assessing the handling error rate (critical and non-critical) in controlled asthmatics currently treated with, and using correctly, SERETIDE via the DISKUS Inhaler who are switched to receiving SERETIDE via the Metered Dose Inhaler (MDI) (EVOHALER) without training by a Healthcare Professional (HCP). This will be a descriptive, multi-centre, open-label, non randomized 14 day study assessing MDI technique in subjects with controlled asthma (Asthma Control Test \[ACT\] score \>= 20 at Visit 1) currently treated with, and able to use correctly, SERETIDE via the DISKUS Inhaler. All the eligible subjects will be switched to an equivalent dose of SERETIDE via the MDI. Subjects will need to use the MDI inhaler in accordance the accompanying patient information leaflet (to be read prior to use) for approximately 14 days. No instruction, coaching or comment on inhaler technique will be provided by the HCP. MDI technique of subjects will be assessed at Visit 2 (after 14 days) and the errors will be recorded. Subject will revert back to using their SERETIDE DISKUS inhaler again from Visit 2. Subjects will be followed up by telephone for approximately 1 week after Visit 2. A maximum of 110 subjects will be enrolled such that approximately 100 evaluable subjects complete the study. The total duration of the study for each subject will be approximately 21 days. SERETIDE, EVOHALER and DISKUS are registered trademarks of the GlaxoSmithKline (GSK) group of companies

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesGermany
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 14, 2015
Enrollment StartJun 18, 2015
Primary CompletionAug 20, 2015
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 11.2 years ago

Interventions

SERETIDE MDIdevice

Commercially available SERETIDE MDI (EVOHALER) containing fluticasone propionate/salmeterol. Subjects will use MDI as 2 inhalations twice daily at the dose equivalent to their usual maintenance treatment of SERETIDE via DISKUS Inhaler.

Placebo DISKUS Inhalerdevice

Placebo dry powder inhaler to be used to demonstrate the use of DISKUS inhaler at Visit 1

Placebo MDIdevice

Clear liquid propellant inhaler to be used to demonstrate the use of MDI at Visit 2