Safety and efficacy of fluticasone/formoterol combination therapy in adolescent and adult patients with mild-to-moderate asthma: a randomised controlled trial

BMC Pulmonary Medicine

Volumn 12, Issue , 2012, Pages

  Nathan, Robert A ^a   D'Urzo, Anthony ^b   Blazhko, Viktor ^c   Kaiser, Kirsten ^d  

^a Asthma and Allergy Associates PC   (United States)

^b UNIVERSITY OF TORONTO   (Canada)

^c Kharkiv City Clinical Hospital #13   (Ukraine)

^d SkyePharma   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

FLUTICASONE PROPIONATE PLUS FORMOTEROL FUMARATE; PLACEBO; SALBUTAMOL;

ADOLESCENT; ADULT; ARTICLE; ASTHMA; CHILD; CONTROLLED STUDY; COUGHING; DIARRHEA; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; FORCED EXPIRATORY VOLUME; FORCED VITAL CAPACITY; HUMAN; LUNG FUNCTION TEST; MAJOR CLINICAL STUDY; MALE; METERED DOSE INHALER; MULTICENTER STUDY; PEAK EXPIRATORY FLOW; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SCHOOL CHILD; TREATMENT DURATION; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION;

ADMINISTRATION, INHALATION; ADOLESCENT; ADULT; ANDROSTADIENES; ASTHMA; BRONCHODILATOR AGENTS; CHILD; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; ETHANOLAMINES; EUROPE; FEMALE; HUMANS; MALE; MIDDLE AGED; NORTH AMERICA; RESPIRATORY FUNCTION TESTS; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84867547348     PISSN: None     EISSN: 14712466     Source Type: Journal    
DOI: 10.1186/1471-2466-12-67     Document Type: Article

References (37)

1. Van Noord JA, Schreurs AJM, Mol SJM, Mulder PGH. Addition of salmeterol versus doubling the dose of fluticasone propionate in patients with mild to moderate asthma. Thorax 1999, 54:207-212.
2. Pauwels RA, Lofdahl CL, Postma DS, Tattersfield AE, O'Byrne P, Barnes PJ, Ullman A. Effect of inhaled formoterol and budesonide on exacerbations of asthma. N Eng J Med 1997, 337:1405-1411.
3. Ward C, Pais M, Bish R, Reid D, Feltis B, Johns D, Walters EH. Airway inflammation, basement membrane thickening and bronchial hyperresponsiveness in asthma. Thorax 2002, 57:309-316.
4. GINA report, global strategy for asthma management and prevention [http://www.ginasthma.com/] 2009 Accessed January 2011.
5. Naedele-Risha R, Dorinsky P, Craig TJ. Dual components of optimal asthma therapy: scientific and clinical rationale for the use of long-acting b-agonists with inhaled corticosteroids. J Am Osteopath Assoc 2001, 1001:526-533.
6. Ducharme FM, Lasserson TJ, Cates CJ. Long-acting beta2-agonists versus anti-leukotrienes as add-on therapy to inhaled corticosteroids for chronic asthma. Cochrane Database Syst Rev 2006, 4:CD003137.
7. Ducharme FM, Ni Chroinin M, Greenstone I, Lasserson TJ. Addition of long-acting beta2-agonists to inhaled corticosteroids versus same dose inhaled corticosteroids for chronic asthma in adults and children. Cochrane Database Syst Rev 2010, 5:CD005535.
8. Greening AP, Ind PW, Northfield M, Shaw G. Added salmeterol versus higher-dose corticosteroid in asthma patients with symptoms on existing inhaled corticosteroid. Lancet 1994, 344:219-224.
9. Woolcock A, Lundback B, Ringdal N, Jacques LA. Comparison of addition of salmeterol to inhaled steroids with doubling of the dose of inhaled steroids. Am J Respir Crit Care Med 1996, 153:1481-1488.
10. O'Byrne PM, Barnes PJ, Rodriguez-Roisin R, Runnerstrom E, Sandstrom T, Svensson K, Tattersfield A. Low dose inhaled budesonide and formoterol in mild persistent asthma. Am J Respir Crit Care Med 2001, 164:1392-1397.
11. Thomas M, Kay S, Pike J, Williams A, Rosenzweig JR, Hillyer EV, Price D. The asthma control test (ACT) as a predictor of GINA guideline-defined asthma control: analysis of a multinational cross-sectional survey. Prim Care Respir J 2009, 18(1):41-49.
12. Frois C, Wu EQ, Ray S, Colice GL. Inhaled corticosteroids or long-acting beta-agonists alone or in fixed-dose combinations in asthma treatment: a systematic review of fluticasone/budesonide and formoterol/salmeterol. Clin Ther 2009, 31(12):2779-2803.
13. Vaessen-Verberne AA, van den Berg NJ, van Nierop JC, Brackel HJ, Gerrits GP, Hop WC, Duiverman EJ, Group CS. Combination therapy salmeterol/fluticasone versus doubling dose of fluticasone in children with asthma. Am J Respir Crit Care Med 2010, 182:1221-1227.
14. Gappa M, Zachgo W, von Berg A, Kamin W, Stern-Sträter C, Steinkamp G, Group VS. Add-on salmeterol compared to double dose fluticasone in pediatric asthma: a double-blind, randomized trial (VIAPAED). Pediatr Pulmonol 2009, 44:1132-1142.
15. Barnes PJ. Scientific rationale for inhaled combination therapy with long-acting beta2-agonists and corticosteroids. Eur Respir J 2002, 19(1):182-191.
16. Barnes PJ. Scientific rationale for using a single inhaler for asthma control. Eur Respir J 2007, 29(3):587-595.
17. Roth M, Zhong J, S'ng CT, Tamm M. Effect of fluticasone and formoterol combination therapy on airway remodeling. Eur Resp J. 2011, 38(Suppl 55):307s.
18. Roth M, Zhong J, S'ng CT, Tamm M. The long-acting β2-agonist formoterol re-establishes the anti-proliferative effect of glucocorticoids in asthmatic airway smooth muscle cells (ASMC). Eur Resp J. 2011, 38(Suppl 55):612s.
19. Kavuru M, Melamed J, Gross G, Laforce C, House K, Prillaman B, Baitinger L, Woodring A, Shah T. Salmeterol and fluticasone propionate combined in a new powder inhalation device for the treatment of asthma: a randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol 2000, 105(6 Pt 1):1108-1116.
20. Ketchell RI, Jensen MW, Spina D, O'Connor BJ. Dose-related effects of formoterol on airway responsiveness to adenosine 5′-monophosphate and histamine. Eur Respir J 2002, 19(4):611-616.
21. Luijk B, Kempsford RD, Wright AM, Zanen P, Lammers JW. Duration of effect of single-dose inhaled fluticasone propionate on AMP-induced bronchoconstriction. Eur Respir J 2004, 23(4):559-564.
22. Adams NP, Bestall JC, Lasserson TJ, Jones P, Cates CJ. Fluticasone versus placebo for chronic asthma in adults and children. Cochrane Database Syst Rev 2008, (4):CD003135.
23. AstraZeneca UK Ltd Symbicort turbohaler 100/6, inhalation powder. Summary of product characteristics 2010, [http://www.medicines.org.uk] Accessed January 2011, AstraZeneca UK Ltd.
24. Politiek MJ, Boorsma M, Aalbers R. Comparison of formoterol, salbutamol and salmeterol in methacholine-induced severe bronchoconstriction. Eur Respir J 1999, 13(5):988-992.
25. Berger WE. The use of inhaled formoterol in the treatment of asthma. Ann Allergy Asthma Immunol 2006, 97(1):24-33.
26. Palmqvist M, Arvidsson P, Beckman O, Peterson S, Lotvall J. Onset of bronchodilation of budesonide/formoterol vs. salmeterol/fluticasone in single inhalers. Pulm Pharmacol Ther 2001, 14(1):29-34.
27. Lotvall J, Ankerst J. Long duration of airway but not systemic effects of inhaled formoterol in asthmatic patients. Respir Med 2008, 102(3):449-456.
28. Bodzenta-Lukaszyk A, Dymek A, McAulay K, Mansikka H. Fluticasone/formoterol combination therapy is as effective as fluticasone/salmeterol in the treatment of asthma, but has a more rapid onset of action: an open-label, randomized study. BMC Pulm Med 2011, 11:28.
29. Bodzenta-Lukaszyk A, Pulka G, Dymek A, Bumbacea D, McIver T, Schwab B, Mansikka H. Efficacy and safety of fluticasone and formoterol in a single pressurized metered dose inhaler. Respir Med 2011, 105(5):674-682.
30. Bousquet J, Winchester C, Papi A, Virchow JC, Haughney J, Costa D, Usmani O, Bjermer L, Price D, Global A, . Asthma European N Inhaled corticosteroid/long-acting beta(2)-agonist combination therapy for asthma: attitudes of specialists in Europe. Int Arch Allergy Immunol 2012, 157(3):303-310. Asthma European N.
31. Guidelines for the Diagnosis and Management of Asthma: Expert Panel Report 2 National Asthma Education and Prevention Program; National Institute of Health; National Heart, Lung, and Blood Institute. 1997, publication No.97-4051 1997, NHLBI, Bethesda, USA, Guidelines for the Diagnosis and Management of Asthma: Expert Panel Report 2.
32. Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 1975, 31(1):103-115.
33. Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J, Force AET. Standardisation of spirometry. Eur Respir J 2005, 26(2):319-338.
34. Polgar G, Promdhat V. Pulmonary function testing in children: techniques and standards 1970, W. B. Sauncers Co, Philadelphia.
35. Crapo RO, Morris AH, Gardner RM. Reference spirometric values using techniques and equipment that meet ATS recommendations. Am Rev Respir Dis 1981, 123(6):659-664.
36. Hochberg Y. A sharper Bonferroni procedure for multiple tests of significance. Biometrika 1988, 75:800-802.
37. García R, Guerra P, Feo F, Galindo PA, Gómez E, Borja J, Fernandez-Pacheco R. Tachyphylaxis following regular use of formoterol in exercise-induced bronchospasm. J Investig Allergol Clin Immunol. 2001, 11(3):176-82.