Efficacy in asthma of once-daily treatment with fluticasone furoate: A randomized, placebo-controlled trial

Respiratory Research

Volumn 12, Issue , 2011, Pages

  Woodcock, Ashley ^a   Bateman, Eric D ^b   Busse, William W ^c   Lötvall, Jan ^d   Snowise, Neil G ^e   Forth, Richard ^f   Jacques, Loretta ^e   Haumann, Brett ^e   Bleecker, Eugene R ^g  

^a UNIVERSITY OF MANCHESTER   (United Kingdom)

^b UNIVERSITY OF CAPE TOWN   (South Africa)

^c UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

^d UNIVERSITY OF GOTHENBURG   (Sweden)

^e GLAXOSMITHKLINE   (United Kingdom)

^f Respiratory and Immuno Inflammation Medicines Development Center   (United States)

^g WAKE FOREST UNIVERSITY HEALTH SCIENCES   (United States)

Author keywords

Asthma; ICS; Once daily

Indexed keywords

FLUTICASONE FUROATE; PLACEBO; ANDROSTANE DERIVATIVE;

ADULT; ANGIONEUROTIC EDEMA; ARTICLE; ASTHMA; BRONCHITIS; CEREBROVASCULAR ACCIDENT; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; DYSPHONIA; EVENING DOSAGE; FEMALE; FORCED EXPIRATORY VOLUME; HEADACHE; HEART ATRIUM FIBRILLATION; HUMAN; INFLUENZA; MAJOR CLINICAL STUDY; MALE; MILD PERSISTENT ASTHMA; MODERATE PERSISTENT ASTHMA; MORNING DOSAGE; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SORE THROAT; SPONTANEOUS ABORTION; THRUSH; UPPER RESPIRATORY TRACT INFECTION; CHEMICALLY INDUCED DISORDER; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; DOUBLE BLIND PROCEDURE; DRUG ADMINISTRATION; DRUG EFFECT; MIDDLE AGED; PATHOPHYSIOLOGY; PHASE 2 CLINICAL TRIAL; PHYSIOLOGY; TREATMENT OUTCOME;

ADULT; ANDROSTADIENES; ASTHMA; BRONCHITIS; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; FORCED EXPIRATORY VOLUME; HEADACHE; HUMANS; MALE; MIDDLE AGED; TREATMENT OUTCOME;

EID: 80053557166     PISSN: 14659921     EISSN: 1465993X     Source Type: Journal    
DOI: 10.1186/1465-9921-12-132     Document Type: Article

References (37)

1. Bahadori K, Doyle-Waters MM, Marra C, Lynd L, Alasaly K, Swiston J, FitzGerald JM. Economic burden of asthma: a systematic review. BMC Pulm Med 2009, 9:24. 10.1186/1471-2466-9-24, 2698859, 19454036.
2. Global Initiative for Asthma (GINA) Global Strategy for Asthma Management and Prevention. 2009, Global Initiative for Asthma (GINA)., http://www.ginasthma.org
3. Masoli M, Fabian D, Holt S, Beasley R. Global Initiative for Asthma (GINA) Program: The global burden of asthma: executive summary of the GINA Dissemination Committee report. Allergy 2004, 59:469-478. 10.1111/j.1398-9995.2004.00526.x, 15080825.
4. Barnes PJ, Pedersen S, Busse WW. Efficacy and safety of inhaled corticosteroids. New developments. Am J Respir Crit Care Med 1998, 157:S1-S53.
5. Pauwels RA, Löfdahl CG, Postma DS, Tattersfield AE, O'Byrne P, Barnes PJ, Ullman A. Effect of inhaled formoterol and budesonide on exacerbations of asthma. Formoterol and Corticosteroids Establishing Therapy (FACET) International Study Group. N Engl J Med 1997, 337:1405-1411. 10.1056/NEJM199711133372001, 9358137.
6. Suissa S, Ernst P, Benayoun S, Baltzan M, Cai B. Low-dose inhaled corticosteroids and the prevention of death from asthma. N Engl J Med 2000, 343:332-336. 10.1056/NEJM200008033430504, 10922423.
7. Rabe KF, Adachi M, Lai CK, Soriano JB, Vermeire PA, Weiss KB, Weiss ST. Worldwide severity and control of asthma in children and adults: the global asthma insights and reality surveys. J Allergy Clin Immunol 2004, 114:40-47. 10.1016/j.jaci.2004.04.042, 15241342.
8. Mintz M, Gilsenan AW, Bui CL, Ziemiecki R, Stanford RH, Lincourt W, Ortega H. Assessment of asthma control in primary care. Curr Med Res Opin 2009, 25:2523-2531. 10.1185/03007990903218655, 19708765.
9. Kandane-Rathnayake RK, Matheson MC, Simpson JA, Tang ML, Johns DP, Mészáros D, Wood-Baker R, Feather I, Morrison S, Jenkins MA, Giles GG, Hopper J, Abramson MJ, Dharmage SC, Walters EH. Adherence to asthma management guidelines by middle-aged adults with current asthma. Thorax 2009, 64:1025-1031. 10.1136/thx.2009.118430, 19703827.
10. Hermosa JL, Sánchez CB, Rubio MC, Mínguez MM, Walther JL. Factors associated with the control of severe asthma. J Asthma 2010, 47:124-130. 10.3109/02770900903518835, 20170317.
11. Price D, Robertson A, Bullen K, Rand C, Horne R, Staudinger H. 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 2010, 10:1. 10.1186/1471-2466-10-1, 2822814, 20051135.
12. Campbell LM, Watson DG, Venables TL, Taylor MD, Richardson PDI. Once daily budesonide turbohaler compared with placebo as initial prophylactic therapy for asthma. Br J Clin Res 1991, 2:111-122.
13. Jones AH, Langdon CG, Lee PS, Lingham SA, Nankani JP, Follows RM, Tollemar U, Richardson PD. Pulmicort Turbohaler once daily as initial prophylactic therapy for asthma. Respir Med 1994, 88:293-299. 10.1016/0954-6111(94)90059-0, 8036292.
14. Herjavecz I, Blomqvist P, Serrano A. Efficacy of once- and twice-daily administration of budesonide via Turbuhaler as initial therapy in patients with mild persistent asthma. Respir Med 1999, 93:230-235. 10.1016/S0954-6111(99)90018-5, 10464886.
15. Noonan M, Karpel JP, Bensch GW, Ramsdell JW, Webb DR, Nolop KB, Lutsky BN. Comparison of once-daily to twice-daily treatment with mometasone furoate dry powder inhaler. Ann Allergy Asthma Immunol 2001, 86:36-43. 10.1016/S1081-1206(10)62353-8, 11206236.
16. Postma DS, Sevette C, Martinat Y, Schlösser N, Aumann J, Kafé H. Treatment of asthma by the inhaled corticosteroid ciclesonide given either in the morning or evening. Eur Respir J 2001, 17:1083-1088. 10.1183/09031936.01.00099701, 11491148.
17. Biggadike K, Bledsoe RK, Hassell AM, Kirk BE, McLay IM, Shewchuk LM, Stewart EL. X-ray crystal structure of the novel enhanced-affinity glucocorticoid agonist fluticasone furoate in the glucocorticoid receptor-ligand binding domain. J Med Chem 2008, 51:3349-3352. 10.1021/jm800279t, 18522385.
18. Salter M, Biggadike K, Matthews JL, West MR, Haase MV, Farrow SN, Uings IJ, Gray DW. Pharmacological properties of the enhanced-affinity glucocorticoid fluticasone furoate in vitro and in an in vivo model of respiratory inflammatory disease. Am J Physiol Lung Cell Mol Physiol 2007, 293:L660-L667. 10.1152/ajplung.00108.2007, 17575011.
19. van den Berge M, Luijk B, Bareille P, Dallow N, Postma DS, Lammers JW. Prolonged protection of the new inhaled corticosteroid fluticasone furoate against AMP hyperresponsiveness in patients with asthma. Allergy 2010, 65:1531-1535. 10.1111/j.1398-9995.2010.02414.x, 20560909.
20. Bateman ED, Bleecker ER, Busse W, Lötvall J, Woodcock A, Forth R, Medley H, Jacques L, Haumann B. Fluticasone furoate (FF), a once-daily inhaled corticosteroid (ICS), demonstrates dose-response efficacy in patients symptomatic on non-steroidal asthma therapy [abstract]. European Respiratory Society 2010, [P1166], 204s.
21. Bleecker ER, Bateman ED, Busse W, Lötvall J, Woodcock A, Tomkins S, House KW, Jacques L, Haumann B. Fluticasone furoate (FF), an inhaled corticosteroid (ICS), is efficacious in asthma patients symptomatic on low doses of ICS therapy [abstract]. European Respiratory Society 2010, [P1167], 204s.
22. Busse W, Bleecker ER, Bateman ED, Lötvall J, Woodcock A, Forth R, Davis AM, Jacques L, Haumann B. Fluticasone furoate (FF), an inhaled corticosteroid (ICS), demonstrates efficacy in asthma patients symptomatic on moderate doses of ICS therapy [abstract]. European Respiratory Society 2010, [P1168], 204s.
23. National Institutes of Health Guidelines for the Diagnosis and Management of Asthma. National Institutes of Health National Heart, Lung and Blood Institute. Bethesda, MD, NHLBI/WHO Originally Printed July 1997, Revised June 2002; August 2007. NIH Publication no: 07-4051, National Institutes of Health.
24. Laszlo G. Standardisation of lung function testing: helpful guidance from the ATS/ERS Task Force. Thorax 2006, 61:744-746. 10.1136/thx.2006.061648, 2117098, 16936234.
25. Meltzer EO, Korenblat PE, Weinstein SF, Noonan M, Karafilidis J. Efficacy and safety evaluation of ciclesonide in mild-to-moderate persistent asthma previously treated with inhaled corticosteroids. Allergy Asthma Proc 2009, 30:293-303. 10.2500/aap.2009.30.3241, 19549431.
26. Berger WE, Kerwin E, Bernstein DI, Pedinoff A, Bensch G, Karafilidis J. Efficacy and safety evaluation of ciclesonide in subjects with mild-to-moderate asthma not currently using inhaled corticosteroids. Allergy Asthma Proc 2009, 30:304-314. 10.2500/aap.2009.30.3242, 19549432.
27. Asmanex Twisthaler Summary of product characteristics (SPC). Mometasone furoate inhalation powder. 2008, (revised 2010), Asmanex Twisthaler.
28. Pinnock H, Thomas M, Tsiligianni I, Lisspers K, Østrem A, Ställberg B, Yusuf O, Ryan D, Buffels J, Cals JW, Chavannes NH, Henrichsen SH, Langhammer A, Latysheva E, Lionis C, Litt J, van der Molen T, Zwar N, Williams S. The International Primary Care Respiratory Group (IPCRG) Research Needs Statement 2010. Prim Care Respir J 2010, 19(Suppl.1):S1-S20.
29. Friedman HS, Navaratnam P, McLaughlin J. Adherence and asthma control with mometasone furoate versus fluticasone propionate in adolescents and young adults with mild asthma. J Asthma 2010,
30. Suissa S, Ernst P, Kezouh A. Regular use of inhaled corticosteroids and the long term prevention of hospitalisation for asthma. Thorax 2002, 57:880-884. 10.1136/thorax.57.10.880, 1746208, 12324675.
31. Schatz M, Cook EF, Nakahiro R, Petitti D. Inhaled corticosteroids and allergy specialty care reduce emergency hospital use for asthma. J Allergy Clin Immunol 2003, 111:503-508. 10.1067/mai.2003.178, 12642829.
32. Lipworth BJ. Systemic adverse effects of inhaled corticosteroid therapy: A systematic review and meta-analysis. Arch Intern Med 1999, 159:941-955. 10.1001/archinte.159.9.941, 10326936.
33. Tabachnik E, Zadik Z. Diurnal cortisol secretion during therapy with inhaled beclomethasone dipropionate in children with asthma. J Pediatr 1991, 118:294-297. 10.1016/S0022-3476(05)80506-2, 1993964.
34. Reinberg A, Smolensky MH, D'Alonzo GE, McGovern JP. Chronobiology and asthma III. Timing corticotherapy to biological rhythms to optimize treatment goals. J Asthma 1988, 25:219-248. 10.3109/02770908809071368, 2846506.
35. Andersson N, Källén A, Thorsson L. A randomized controlled assessment of the effects of different dosing regimens of budesonide on the HPA-axis in healthy subjects. Br J Clin Pharmacol 2001, 51:325-328. 2014452, 11318767.
36. Kosoglou T, Cutler DL, Staudinger H, Herron JM. Once-daily evening dosing of mometasone furoate administered via a dry powder inhaler does not adversely affect the hypothalamic-pituitary-adrenal axis. Chest 2010, 137:115-121. 10.1378/chest.09-0235, 19749003.
37. Boulet LP. Once-daily inhaled corticosteroids for the treatment of asthma. Curr Opin Pulm Med 2004, 10:15-21. 10.1097/00063198-200401000-00004, 14749601.