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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
(N=609)

 

FFA114496
(N=219)

 

FFA115283
(N=222)

 

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.

 

 

 

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Presented at the European Respiratory Society Annual Congress, Barcelona, Spain, 7–11 September 2013