Asthma Clinical Trial
Official title:
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
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
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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