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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
111
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 dry powder inhaler to be used to demonstrate the use of DISKUS inhaler at Visit 1
Clear liquid propellant inhaler to be used to demonstrate the use of MDI at Visit 2
GSK Investigational Site
Frankfurt am Main, Hesse, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, Germany
GSK Investigational Site
Neu-Isenburg, Hesse, Germany
GSK Investigational Site
Reinfeld, Schleswig-Holstein, Germany
GSK Investigational Site
Berlin, Germany
GSK Investigational Site
Berlin, Germany
GSK Investigational Site
Berlin, Germany
Percentage of Participants Making at Least One Critical Error After the First Assessment of Metered Dose Inhaler (MDI) Technique on Day 14
Participant's inhaler use was assessed on Day 14 by the health care professional (HCP) against a predefined list of critical errors (CEs). Critical errors were defined as errors that were most likely to result in no or only minimal medication being inhaled. The participants were asked to demonstrate their usage of the MDI using a placebo demonstration MDI by HCP, critical or non-critical errors (N-CEs) and even no errors made by the participants while using the MDI were recorded. Critical errors in using the MDI were defined as: failure to remove the cap; failure to shake the device; failure to place the device in mouth; no dose actuated during an inhalation manoeuvre; dose coordination that was so poor that the patient was likely to have received no dose or only received minimal dose. 95% confidence interval (CI) is for the % of participants making at least one critical error after the first assessment of the MDI technique, and was calculated using the exact binomial distribution.
Time frame: Day 14
Percentage of Participants Making at Least One Overall Error After the First Assessment of MDI Technique on Day 14.
Inhaler use was assessed on Day 14 for overall errors. Overall errors included CEs or N-CEs. Demonstration of usage was with MDI and placebo, CE or N-CEs and even no errors were recorded. CEs were defined as: failure to remove the cap; failure to shake the device; failure to place the device in mouth; no dose actuated during an inhalation manoeuvre; dose coordination that was so poor that the patient was likely to have received no dose or only received minimal dose. N-CEs were defined as: failure to inhale within 5 seconds of shaking the device; no exhalation before an inhalation; the inhalation manoeuvre was not slow and/or was not deep; dose coordination was sub-optimal but patient likely to have received some dose; more than one actuation during an inhalation manoeuvre; did not hold breath. The exact 95% confidence interval is for percent of participants making at least one CE after the first assessment of the MDI technique, and was calculated using exact binomial distribution.
Time frame: Day 14
Number of Health Care Professional (HCP) Instructions Required on Day 14
Participant's inhaler use was assessed on Day 14 by the HCP against a predefined list of critical errors. If a participant made a critical error during this initial assessment, the HCP demonstrated the correct use of the inhaler to the participant and gave verbal instructions. The participant was then asked to demonstrate inhaler use. Any errors were recorded by the HCP. If the participant made a critical error then the HCP repeated the demonstration of inhaler use to the participant for a second time. If the participant continued to make a critical error in the use of the inhaler, the HCP demonstrated the correct use of the inhaler and gave verbal instructions one more time and the participant was then asked to demonstrate inhaler use. Instructions are only given to subjects who make a critical error. Any errors made after this final demonstration were recorded.
Time frame: Day 14
Time Taken to Correctly Completing Inhaler Use at Day 14
If a participant made a critical error during the initial assessment, the HCP demonstrated the correct use of the inhaler to the participant and gave verbal instructions. The HCP could have demonstrated the use of the inhaler a maximum of three times. Any errors made after this final demonstration were recorded. The time taken for the HCP to train the participant in the correct technique was recorded as T1: the time from when the participants started their demonstration of MDI use until they had completed their demonstration of MDI use (i.e., with no HCP support), T2: the time from when the HCP started to demonstrate/instruct device use until correct use was demonstrated by the participant (up to a maximum of three attempts only). T3 is defined as T1+T2, which is the time from when the participant started to demonstrate MDI use until correct use was demonstrated by the subject (up to a maximum of three attempts following demonstration by HCP).
Time frame: Day 14
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