The efficacy of once-daily fluticasone furoate/vilanterol in asthma is comparable with morning or evening dosing

Respiratory Medicine

Volumn 107, Issue 12, 2013, Pages 1873-1880

  Kempsford, Rodger D ^a   Oliver, Amanda ^a   Bal, Joanne ^a   Tombs, Lee ^b   Quinn, Dean ^c  

^a GLAXOSMITHKLINE   (United Kingdom)

^b Synergy Statistics and Programming   (United Kingdom)

^c P3 Research   (New Zealand)

Author keywords

Asthma; Efficacy; Evening dosing; Fluticasone furoate; Morning dosing; Vilanterol

Indexed keywords

FLUTICASONE FUROATE PLUS VILANTEROL; PLACEBO;

ADULT; AGED; ARTICLE; ASTHMA; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOSAGE SCHEDULE COMPARISON; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG WITHDRAWAL; DRY POWDER INHALER; EPISTAXIS; EVENING DOSAGE; FEMALE; HEADACHE; HUMAN; LUNG FUNCTION; MALE; MORNING DOSAGE; PEAK EXPIRATORY FLOW; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS;

ASTHMA; EFFICACY; EVENING DOSING; FLUTICASONE FUROATE; MORNING DOSING; VILANTEROL;

ADMINISTRATION, INHALATION; ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANALYSIS OF VARIANCE; ANDROSTADIENES; ASTHMA; BENZYL ALCOHOLS; CHLOROBENZENES; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; FORCED EXPIRATORY VOLUME; HUMANS; MALE; MIDDLE AGED; PEAK EXPIRATORY FLOW RATE; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84890310895     PISSN: 09546111     EISSN: 15323064     Source Type: Journal    
DOI: 10.1016/j.rmed.2013.07.002     Document Type: Article

References (37)

1. From the Global Strategy for Asthma Management and Prevention Global initiative for asthma (GINA) 2012 Available from: http://www.ginasthma.org/ [accessed 20.03.13]
2. National Institutes of Health. Guidelines for the diagnosis and management of asthma. Bethesda, MD: National Institutes of Health National Heart, Lung and Blood Institute. NHBLI/WHO originally printed July 1997. Revised June 2002; August 2007. NIH publication no: 07-4051.
3. Seretide Accuhaler fluticasone propionate/salmeterol inhalation powder summary of product characteristics [online]. Available from: http://www.medicines.org.uk/EMC/medicine/2317/SPC/ Seretide+100%2c+250%2c+500+Accuhaler/#PRODUCTINFO [accessed 20.03.13].
4. Symbicort Turbohaler budesonide/formoterol inhalation powder summary of product characteristics [online]. Available from: http://www.medicines.org.uk/ emc/medicine/4820/SPC#PRODUCTINFO [accessed 20.03.13].
5. ® mometasone furoate/formoterol powder for inhalation prescribing information [online]. Available from: https://www.merck.com/product/usa/pi-circulars/d/dulera/dulera-pi.pdf [accessed 21.05.13].
6. 2-adrenoreceptor agonist Core Evid 4 2009 37 41
7. M. Cazzola, and M.G. Matera Emerging inhaled bronchodilators: an update Eur Respir J 34 2009 757 769
8. C. LaForce, M. Alexander, R. Deckelmann, L.M. Fabbri, Z. Aisanov, and R. Cameron Indacaterol provides sustained 24 h bronchodilation on once-daily dosing in asthma: a 7-day dose-ranging study Allergy 63 2008 103 111
9. D. Price, A. Robertson, K. Bullen, C. Rand, R. Horne, and H. Staudinger Improved adherence with once-daily versus twice-daily dosing of mometasone furoate administered via a dry powder inhaler: a randomized open-label study BMC Pulm Med 10 2010 1
10. E.R. Bleecker, J. Lötvall, P.M. O'Byrne, A. Woodcock, W.W. Busse, and R. Forth Efficacy of fluticasone furoate (FF) as a monotherapy and in combination with vilanterol (VI) over 12 weeks in patients with persistent asthma Eur Respir J 40 Suppl. 56 2012 S370
11. P.M. O'Byrne, E.R. Bleecker, E.D. Bateman, W.W. Busse, A. Woodcock, and R. Forth Efficacy and safety of fluticasone furoate (FF)/vilanterol (VI) once daily (OD) for 24 weeks in persistent asthma Eur Respir J 40 Suppl. 56 2012 S313
12. Woodcock A, Bleecker ER, Lötvall J, O'Byrne P, Bateman ED, Medley H, et al. Efficacy and safety of fluticasone furoate/vilanterol compared with fluticasone propionate/- salmeterol combination in adults and adolescent patients with persistent asthma. Chest Jul 11. http://dx.doi.org/10.1378/chest. 13-0178. [Epub ahead of print].
13. J. Lötvall, P. Bakke, L. Bjermer, S. Steinshamn, C. Crim, and L. Sanford Efficacy and safety of 4 weeks' treatment with combined fluticasone furoate/vilanterol in a single inhaler given once daily in COPD: a placebo-controlled randomised trial BMJ Open 2 2012 e000370
14. J.A. Boscia, K.K. Pudi, M.T. Zvarich, L. Sanford, S.K. Siederer, and C. Crim Effect of once-daily fluticasone furoate/vilanterol on 24-hour pulmonary function in patients with chronic obstructive pulmonary disease: a randomized, three-way, incomplete block, crossover study Clin Ther 34 2012 1655 1666
15. D.J. Pincus, S.J. Szefler, L.M. Ackerson, and R.J. Martin Chronotherapy of asthma with inhaled steroids: the effect of dosage timing on drug efficacy J Allergy Clin Immunol 95 1995 1172 1178
16. W.R. Beam, D.E. Weiner, and R.J. Martin Timing of prednisone and alterations in airways inflammation in nocturnal asthma Am Rev Respir Dis 146 1992 1524 1530
17. P.M.A. Calverley, A. Lee, L. Towse, J. van Noord, T.J. Witek, and S. Kelsen Effect of tiotropium bromide on circadian variation in airflow limitation in chronic obstructive pulmonary disease Thorax 58 2003 855 860
18. M.H. Smolensky, J.P. McGovern, P.H. Scott, and A. Reinberg Chronobiology and asthma. II. Body-time-dependent differences in the kinetics and effects of bronchodilator medications J Asthma 24 1987 91 134
19. M.F. Muers Diurnal variation in asthma Arch Dis Child 59 1984 898 901
20. J.P. Karpel, W.W. Busse, M.J. Noonan, M.E. Monahan, B. Lutsky, and H. Staudinger Effects of mometasone furoate given once daily in the evening on lung function and symptom control in persistent asthma Ann Pharmacother 39 2005 1977 1983
21. R.J. Martin, and S. Banks-Schlegal Chronobiology of asthma. NHBLI workshop summary Am J Crit Care Med 158 1998 1002 1007
22. A. Woodcock, E.D. Bateman, W.W. Busse, J. Lötvall, N.G. Snowise, and R. Forth Efficacy in asthma of once-daily treatment with fluticasone furoate: a randomized, placebo-controlled trial Respir Res 12 2011 132
23. A.H. Jones, C.G. Langdon, P.S. Lee, S.A. Lingham, J.P. Nankani, and R.M. Follows Pulmicort Turbohaler once daily as initial prophylactic therapy for asthma Respir Med 88 1994 293 299
24. M. Noonan, J.P. Karpel, G.W. Bensch, J.W. Ramsdell, D.R. Webb, and K.B. Nolop Comparison of once-daily to twice-daily treatment with mometasone furoate dry powder inhaler Ann Allergy Asthma Immunol 86 2001 36 43
25. K. Wu, N. Goyal, J.G. Stark, and G. Hochhaus Evaluation of the administration time effect on the cumulative cortisol suppression and cumulative lymphocytes suppression for once-daily inhaled corticosteroids: a population modeling/simulation approach J Clin Pharmacol 48 2008 1069 1080
26. J.L. Hankinson, J.R. Odencrantz, and K.B. Fedan Spirometric reference values from a sample of the general U.S. population Am J Respir Crit Care Med 159 1999 179 187
27. M.R. Miller, J. Hankinson, V. Brusasco, F. Burgos, R. Casaburi, and A. Coates Standardisation of spirometry. Series "ATS/ERS task force: standardisation of lung function testing" Eur Respir J 26 2005 319 338
28. N.C. Santanello, J. Zhang, B. Seidenberg, T.F. Reiss, and B.L. Barber What are minimal important changes for asthma measures in a clinical trial? Eur Respir J 14 1999 23 27
29. R. Jaeschke, J. Singer, and G.H. Guyatt Measurement of health status: ascertaining the minimal clinically important difference Control Clin Trials 10 1989 407 415
30. H. Magnussen, C. Verkindre, D. Jack, D. Jadayel, M. Henley, R. Woessner on behalf of the INPUT Study Investigators Indacaterol once-daily is equally effective dosed in the evening or morning in COPD Respir Med 104 2010 1869 1876
31. D.S. Postma, C. Sevette, Y. Martinat, N. Schlösser, J. Aumann, and H. Kafé Treatment of asthma by the inhaled corticosteroid ciclesonide given either in the morning or evening Eur Respir J 17 2001 1083 1088
32. K. Phillips, J. Oborne, S. Lewis, T.W. Harrison, and A.E. Tattersfield Time course of action of two inhaled corticosteroids, fluticasone propionate and budesonide Thorax 59 2004 26 30
33. A. D'Urzo, J.P. Karpel, W.W. Busse, L.-P. Boulet, M.E. Monahan, and B. Lutsky Efficacy and safety of mometasone furoate administered once-daily in the evening in patients with persistent asthma dependent on inhaled corticosteroids Curr Med Res Opin 21 2005 10.1185/030079905X56402
34. B. Meibohm, G. Hochhaus, S. Rohatagi, H. Möllmann, J. Barth, and M. Wagner Dependency of cortisol suppression on the administration time of inhaled corticosteroids J Clin Pharmacol 37 1997 704 710
35. W.W. Busse, E.R. Bleecker, E.D. Bateman, J. Lötvall, R. Forth, and A.M. Davis Fluticasone furoate demonstrates efficacy in patients with asthma symptomatic on medium doses of inhaled corticosteroid therapy: an 8-week randomised, placebo-controlled trial Thorax 67 2012 35 41
36. A. Allen, I. Schenkenberger, R. Trivedi, J. Cole, W. Hicks, and N. Gul Inhaled fluticasone furoate/vilanterol does not affect hypothalamic-pituitary- adrenal axis function in adolescent and adult asthma: randomised, double-blind, placebo-controlled study Clin Respir J 2013 Apr 12 10.1111/crj.12026 [Epub ahead of print]
37. F.J. Martinez, J. Boscia, G. Feldman, C. Scott-Wilson, S. Kilbride, and L. Fabbri Fluticasone furoate/vilanterol (100/25; 200/25 μg) improves lung function in COPD: a randomised trial Respir Med 107 2013 550 559