Comparison of the clinical efficacy and safety of salmeterol/fluticasone propionate versus current care in the management of persistent asthma in Korea

ABSTRACT

Objectives: In the Asia-Pacific region there is a general preference for prescribing oral over inhaled medications for the treatment of asthma. This study compared inhaled salmeterol/fluticasone propionate therapy (SFC) with physician-determined current care (CC) in the management of persistent asthma in Korea.

Methods: Adult patients with a documented history of reversibility in FEV₁ (≥ 12%) or PEF (≥ 15%), were randomised in a 2:1 ratio to unblinded treatment with SFC (50/250 μg bd or 50/500 μg bd) via Diskus (N = 284) or CC (N = 140) for 52 weeks. Morning peak expiratory flow (PEF) (primary endpoint), exacerbations, asthma symptoms and patient-reported outcome measures were recorded.

Trial registration: GSK study number:100614.

Results: At baseline, mean morning PEF in the SFC and CC group was 374 and 401 L/min respectively. The adjusted mean morning PEF at 52 weeks was 423 ± 3 and 396 ± 4 L/min for SFC and CC respectively (treatment difference of 27 ± 5 in favour of SFC; 95% CI 17, 37; p < 0.0001). The mean rate of exacerbations over 52 weeks was significantly lower in the SFC group (SFC/CC odds ratio 0.57; 95% CI 0.44, 0.74; p < 0.0001). Treatment with SFC also resulted in a significantly greater improvement in asthma symptoms, in the number of patients assessed to have well controlled asthma (Asthma Control Test score ≥ 20), and in a clinically significant improvement in overall Quality of Life. The incidence of adverse events was low and similar between the two groups and events were of the type expected in this population.

Conclusions: The results of this open-label, randomised study showed that SFC provided greater asthma control than CC in the management of persistent asthma.

Key words: :

• Salmeterol/fluticasone propionate combination
• Current care
• Persistent asthma

Acknowledgements

Declaration of interest: This study was funded by GlaxoSmithKline (GSK) and GSK were involved in the study design and writing of the manuscript. A.W. and R.C. are employees of GSK and hold GSK shares. K-S.J., S-T.U., Y-C.L., J-J.S. and S-K.P. have no conflicts of interest to declare. All authors reviewed the data analysis and were involved in the interpretation of the data and the writing of the manuscript.

The authors also thank the following: Sally Anderton (GSK employee) for her advice on the statistical analyses; Namrata Taak, Nam-Hee Kwon and Raj Sharma (all GSK employees) and Kate Hollingworth (on behalf of GSK) for their help in preparing the manuscript.

Thanks are extended to all the participating investigators in this clinical study (GSK study number 100614): Seung-Hoon Jang, Ki-Woon Kwon, Jin-Woo Jeon, Jae-Myung Lee, Young-Mok Lee, Yang-Ki Kim, Ki-Up Kim, Shin-Young Ki, Suk-Hwan Yoon, Ki-Won Jeon, Jeong-Seon Song, Ki-Tae Cheon, Deok-Su Cho, Min-Ki Lee, Yun-Seong Kim, Soo-Keol Lee, Joo-In Kim, Dong-Seung Yeo, Bong-Chun Lee, Hyo-Kyung Park, Hyun-Min Kwon, Seung-Chul Yu and Woo-Je Jung.

Notes

* Diskus is a Trademark of GlaxoSmithKline, London, United Kingdom

* Asthma Control Test is a trademark of QualityMetric incorporated © 2002