Exhibit 99.3
Ease of use of a two-strip dry powder inhaler (DPI) to deliver fluticasone furoate/vilanterol (FF/VI) and FF alone in asthma
Poster No. P701
Svedsater H(1), Jacques L(2), Goldfrad C(3), Bleecker ER(4), O’Byrne PM(5), Woodcock A(6)
(1)Global Health Outcomes, GlaxoSmithKline, Stockley Park, UK; (2)Respiratory Medicines Development Centre, GlaxoSmithKline, Uxbridge, UK; (3)Quantitative Sciences Division, GlaxoSmithKline, Uxbridge, UK; (4)Center for Genomics and Personalized Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA; (5)Michael G DeGroote School of Medicine, McMaster University, Hamilton, Canada; (6) Institute of Inflammation and Repair, University of Manchester, Manchester, UK
INTRODUCTION
· Difficulty in inhaler use, and incorrect use, are associated with two types of poor adherence to prescribed asthma treatment(1),(2)
· intentional non-adherence: the patient chooses not to take the medication
· non-intentional (unconscious) non-adherence: the patient does not receive the prescribed dose of medication because of incorrect inhaler use.
· The ELLIPTA™ DPI is a handheld inhaler with built-in dose counter, approved for the delivery of fluticasone furoate (FF) alone and in combination with vilanterol (VI), and in development for other new inhaled therapies
· US approval granted for FF/VI treatment of COPD on 10 May 2013.
OBJECTIVES
· To assess the perception of the ease of use of the ELLIPTA DPI among patients with asthma participating in randomised clinical trials.
· To assess participating patients’ competence in the use of the ELLIPTA DPI, as judged by trial investigators.
METHODS
· All participants completed one of the following studies of FF/VI or FF dosed once daily via the ELLIPTA DPI (Figure 1).
Figure 1. The ELLIPTA DPI
ELLIPTA™ is a trade mark of the GlaxoSmithKline group of companies
· Clinical studies from which participants (Table 1) were recruited
· HZA106827 (NCT01165138), a 12-week study of FF/VI 100/25mcg, FF 100mcg and placebo
· FFA114496 (NCT01431950), a 24-week study of FF 100mcg and FF 200mcg
· FFA115283 (NCT01436071), a 12-week study of FF 50mcg and placebo.
Table 1. Participant demographics and lung function characteristics
|
| HZA106827 |
| FFA114496 |
| FFA115283 |
|
Age, years |
| 39.7 (16.6) |
| 46.4 (15.4) |
| 35.2 (15.1) |
|
Female sex, n (%) |
| 353 (58) |
| 148 (68) |
| 133 (60) |
|
Duration of asthma, years |
| 12.1 (11.4) |
| 20.5 (15.5) |
| 16.6 (12.0) |
|
Pre-bronchodilator FEV1, L |
| 2.23 (0.60) |
| 1.97 (0.58) |
| 2.49 (0.69) |
|
% predicted FEV1, L |
| 67.59 (11.22) |
| 65.32 (12.33) |
| 76.02 (11.37) |
|
% FEV1 reversibility to salbutamol |
| 28.7 (18.3) |
| 32.3 (18.5) |
| 24.5 (10.1) |
|
Data for intent-to-treat population. All data are mean (SD) unless otherwise stated
Lung function data were recorded at the screening visit
FEV1, forced expiratory volume in one second
Inhaler user assessment
· Trial investigators assessed patients’ competence in the usage of the ELLIPTA DPI at baseline, and again at Week 2 and Week 4 of the treatment period.
· Patients who did not use the DPI correctly were provided with additional instruction in its use.
RESULTS
Ease of use questionnaire (Table 3)
· Across the three trials, 94% of patients reported the ELLIPTA DPI to be easy or very easy to use.
· 96% reported that it was easy or very easy to tell how many doses of medication were left in the inhaler using the ELLIPTA DPI’s built-in dose counter.
Table 3. Ease of use questionnaire results
|
| HZA106827 |
| FFA114496 |
| FFA115283 |
| Total |
|
n |
| 570 |
| 213 |
| 206 |
| 989 |
|
How do you rate the ease of use of the inhaler?
Very easy |
| 362 (64) |
| 146 (69) |
| 132 (64) |
| 640 (65) |
|
Easy |
| 157 (28) |
| 64 (30) |
| 68 (33) |
| 289 (29) |
|
Neutral |
| 43 (8) |
| 3 (1) |
| 4 (2) |
| 50 (5) |
|
Difficult |
| 7 (1) |
| 0 |
| 2 (<1) |
| 9 (1) |
|
Very difficult |
| 1 (<1) |
| 0 |
| 0 |
| 1 (<1) |
|
How easily are you able to tell how many doses of medication are left in the inhaler?
Very easy |
| 419 (74) |
| 169 (79) |
| 144 (70) |
| 732 (74) |
|
Easy |
| 126 (22) |
| 42 (20) |
| 51 (25) |
| 219 (22) |
|
Neutral |
| 22 (4) |
| 2 (<1) |
| 8 (4) |
| 32 (3) |
|
Difficult |
| 3 (<1) |
| 0 |
| 1 (<1) |
| 4 (1) |
|
Very difficult |
| 0 |
| 0 |
| 2 (<1) |
| 2 (<1) |
|
All data are n (%)
Inhaler use assessment (Table 4)
· 95% of patients used the ELLIPTA DPI correctly as adjudicated by the investigator after a single demonstration of correct usage at the baseline (Week 0) visit.
· >99% of patients used the DPI correctly at Week 2 and at Week 4.
REFERENCES
(1) Horne R. Prim Care Respir J 2011;20:118–9.
(2) Cochrane GM, et al. Respir Med 1999;93:763–9.
ACKNOWLEDGEMENTS
· The presenting author, Henrik Svedsater, declares the following real or perceived conflicts of interest during the last 3 years in relation to this presentation: is an employee of and holds stock in GlaxoSmithKline.
· This study was funded by GlaxoSmithKline (HO-11-762).
· Editorial support (in the form of writing assistance, assembling tables and figures, collating author comments, grammatical editing and referencing) was provided by Ian Grieve, PhD at Gardiner-Caldwell Communications (Macclesfield, UK) and was funded by GlaxoSmithKline.
Table 4. Inhaler use assessment results
|
| HZA106827 |
| FFA114496 |
| FFA115283 |
| Total |
|
|
|
|
|
|
|
|
|
|
|
Week 0* |
|
|
|
|
|
|
|
|
|
n |
| 609 |
| 218 |
| 222 |
| 1049 |
|
Patient used inhaler correctly |
| 578 (95) |
| 206 (94) |
| 216 (97) |
| 1000 (95) |
|
One further instruction required |
| 22 (4) |
| 11 (5) |
| 5 (2) |
| 38 (4) |
|
Two further instructions required |
| 8 (1) |
| 1 (<1) |
| 1 (<1) |
| 10 (1) |
|
>2 further instructions required |
| 1 (<1) |
| 0 |
| 0 |
| 1 (<1) |
|
Week 2 |
|
|
|
|
|
|
|
|
|
n |
| 593 |
| 215 |
| 216 |
| 1024 |
|
Patient used inhaler correctly |
| 593 (100) |
| 211 (98) |
| 216 (100) |
| 1020 (>99) |
|
One further instruction required |
| 0 |
| 3 (1) |
| 0 |
| 3 (<1) |
|
Two further instructions required |
| 0 |
| 1 (<1) |
| 0 |
| 1 (<1) |
|
>2 further instructions required |
| 0 |
| 0 |
| 0 |
| 0 |
|
Week 4 |
|
|
|
|
|
|
|
|
|
n |
| 569 |
| 213 |
| 206 |
| 988 |
|
Patient used inhaler correctly |
| 569 (100) |
| 210 (99) |
| 205 (>99) |
| 984 (>99) |
|
One further instruction required |
| 0 |
| 3 (1) |
| 1 (<1) |
| 4 (<1) |
|
Two further instructions required |
| 0 |
| 0 |
| 0 |
| 0 |
|
>2 further instructions required |
| 0 |
| 0 |
| 0 |
| 0 |
|
*After one demonstration of correct usage at the baseline clinic visit
CONCLUSIONS
· Patients with asthma participating in clinical trials using the ELLIPTA DPI found the inhaler to be easy to use, and its dose counter to be intuitive and clearly readable.
· Few instances of incorrect use of the DPI were reported.
· The findings reported here suggest that the ELLIPTA DPI is perceived positively and used correctly by patients with asthma.
|
|
| Placeholder |
Presented at the European Respiratory Society Annual Congress, Barcelona, Spain, 7–11 September 2013