Clinical Drug Investigation

, Volume 28, Issue 3, pp 169–181 | Cite as

Salmeterol/Fluticasone Propionate via Diskus™ Once Daily versus Fluticasone Propionate Twice Daily in Patients with Mild Asthma not Previously Receiving Maintenance Corticosteroids

Original Research Article

Abstract

Background and objective:

The efficacy and safety of twice-daily inhaled salmeterol/fluticasone propionate combination (SFC) therapy have been well established in the treatment of adults and adolescents with asthma. Once-daily administration of SFC could also be appropriate in patients with mild persistent asthma. This study aimed to investigate whether once-daily SFC 50 μg/100 μg was at least as effective as fluticasone propionate (FP) 100 μg twice daily, and more effective than twice-daily placebo, over 52 weeks as initial maintenance therapy in patients with mild persistent asthma.

Methods:

This was a randomized, double-blind, double-dummy, placebo-controlled, multicentre, parallel-group study carried out in primary and secondary care. Patients aged between 12 and 79 years with a documented clinical history of asthma for ≥6 months who were currently receiving inhaled short-acting β2-adrenoceptor agonists only were enrolled. Patients were randomized to receive either once-daily inhaled SFC 50 μg/100 μg, twice-daily inhaled FP 100 μg (i.e. twice the dose of FP compared with SFC) or placebo for 52 weeks. The primary efficacy endpoints were mean morning peak expiratory flow (PEF), as recorded by patients prior to the use of bronchodilator or study medication, and the rate of investigator-recorded asthma exacerbations.

Results:

Patients receiving twice-daily FP and once-daily SFC showed greater improvements in mean morning PEF compared with those receiving placebo (FP, difference in means 20.1 L/min; 95% CI 14.7, 25.5; p < 0.001; SFC, difference in means 14.8 L/min; 95% CI 9.4, 20.2; p < 0.001). The difference in adjusted mean PEF between once-daily SFC and twice-daily FP was —5.3 L/min (95% CI −9.1,−1.6). PEF results showed that once-daily SFC was non-inferior to twice-daily FP. Over 52 weeks, there was a 35% reduction in exacerbation rates with once-daily SFC, which in this respect demonstrated superiority over placebo (p < 0.001). Non-inferiority between once-daily SFC and twice-daily FP with respect to exacerbation rates was not shown. Once-daily SFC significantly improved clinic forced expiratory flow between 25% and 75% of forced vital capacity (difference in means 0.129 L/s; p < 0.001) and clinic PEF (difference in means 10.8 L/min; p < 0.001) compared with twice-daily FP. Both treatments were well tolerated and the safety profile of each was similar to that seen with placebo.

Conclusion:

In patients with mild persistent asthma not previously receiving maintenance therapy, once-daily SFC 50 μg/100 μg is an effective treatment compared with placebo, and was non-inferior to twice-daily FP 100 μg with respect to mean morning PEF. However, in this study, once-daily SFC was not as efficacious as twice-daily FP in reducing asthma exacerbation rates. This study confirms the benefits of regular maintenance treatment in patients with mild persistent asthma.

Keywords

Asthma Fluticasone Propionate Salmeterol Peak Expiratory Flow Mometasone Furoate 

Notes

Acknowledgements

Funding for this study was provided by GlaxoSmithKline Research and Development Ltd (protocol SAS30024). The authors would like to thank their fellow investigators. The authors also thank Dr Cheryl Jenkins, an employee of Innovex Medical Communications, for writing assistance and manuscript management.

Alexander Chuchalin has no conflicts of interest that are directly relevant to the content of this study. Loretta Jacques and Lucy Frith are employees of GlaxoSmithKline, the sponsor of the study.

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Copyright information

© Adis Data Information BV 2008

Authors and Affiliations

  • Alexander Chuchalin
    • 1
  • Loretta Jacques
    • 2
  • Lucy Frith
    • 2
  1. 1.Pulmonology Research InstituteMoscowRussia
  2. 2.GlaxoSmithKline Research and Development LimitedGreenfordUK

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