Effect of montelukast added to inhaled budesonide on control of mild to moderate asthma

M J Vaquerizo, P Casan, J Castillo, M Perpiña, J Sanchis, V Sobradillo, A Valencia, H Verea, J L Viejo, C Villasante, J Gonzalez-Esteban, C Picado, CASIOPEA (Capacidad de Singulair Oral en la Prevencion de Exacerbaciones Asmaticas) Study Group, M J Vaquerizo, P Casan, J Castillo, M Perpiña, J Sanchis, V Sobradillo, A Valencia, H Verea, J L Viejo, C Villasante, J Gonzalez-Esteban, C Picado, CASIOPEA (Capacidad de Singulair Oral en la Prevencion de Exacerbaciones Asmaticas) Study Group

Abstract

Background: Proinflammatory leukotrienes, which are not completely inhibited by inhaled corticosteroids, may contribute to asthmatic problems [corrected]. A 16 week multicentre, randomised, double blind, controlled study was undertaken to study the efficacy of adding oral montelukast, a leukotriene receptor antagonist, to a constant dose of inhaled budesonide.

Methods: A total of 639 patients aged 18-70 years with forced expiratory volume in 1 second (FEV(1)) > or =55% predicted and a minimum predefined level of asthma symptoms during a 2 week placebo run in period were randomised to receive montelukast 10 mg (n=326) or placebo (n=313) once daily for 16 weeks. All patients received a constant dose of budesonide (400-1600 microg/day) by Turbuhaler throughout the study.

Results: Mean FEV(1) at baseline was 81% predicted. The median percentage of asthma exacerbation days was 35% lower (3.1% v 4.8%; p=0.03) and the median percentage of asthma free days was 56% higher (66.1% v 42.3%; p=0.001) in the montelukast group than in the placebo group. Patients receiving concomitant treatment with montelukast had significantly (p<0.05) fewer nocturnal awakenings and significantly (p<0.05) greater improvements in beta agonist use and morning peak expiratory flow rate (PEFR).

Conclusions: For patients with mild airway obstruction and persistent asthma symptoms despite budesonide treatment, concomitant treatment with montelukast significantly improves asthma control.

References

    1. Am J Respir Crit Care Med. 1999 Dec;160(6):1862-8
    1. Ann Intern Med. 2000 Jan 18;132(2):97-104
    1. J Asthma. 2000 Jun;37(4):303-18
    1. Am J Respir Crit Care Med. 2000 Aug;162(2 Pt 1):578-85
    1. J Allergy Clin Immunol. 2000 Dec;106(6):1088-95
    1. J Pediatr. 2001 May;138(5):694-8
    1. Chest. 2001 Aug;120(2):423-30
    1. Chest. 2002 Jun;121(6):2083-4
    1. J Psychosom Res. 1973 Nov;17(4):293-7
    1. Br Med J (Clin Res Ed). 1988 Apr 30;296(6631):1210-1
    1. Thorax. 1992 Feb;47(2):76-83
    1. N Engl J Med. 1992 Oct 22;327(17):1198-203
    1. Lancet. 1993 Apr 17;341(8851):989-90
    1. Am Rev Respir Dis. 1993 Jun;147(6 Pt 1):1472-6
    1. Am J Respir Crit Care Med. 1994 Apr;149(4 Pt 1):953-9
    1. Arch Intern Med. 1994 Jun 27;154(12):1349-52
    1. Pharmacoeconomics. 1993 Nov;4(5):345-52
    1. Am J Respir Crit Care Med. 1994 Oct;150(4):1006-11
    1. N Engl J Med. 1995 Mar 30;332(13):868-75
    1. Trends Pharmacol Sci. 1995 Sep;16(9):304-9
    1. Am J Respir Crit Care Med. 1996 Jan;153(1):454-7
    1. Am J Respir Crit Care Med. 1996 Oct;154(4 Pt 1):889-93
    1. Am J Respir Crit Care Med. 1996 Dec;154(6 Pt 1):1603-7
    1. Am J Respir Crit Care Med. 1997 Feb;155(2):542-8
    1. Eur Respir J. 1997 Mar;10(3):646-51
    1. Pediatrics. 1997 May;99(5):655-9
    1. Chest. 1997 May;111(5):1249-54
    1. BMJ. 1997 May 17;314(7092):1441-6
    1. N Engl J Med. 1997 Nov 13;337(20):1405-11
    1. Arch Intern Med. 1998 Jun 8;158(11):1213-20
    1. N Engl J Med. 1998 Jul 16;339(3):147-52
    1. N Engl J Med. 1999 Jan 21;340(3):197-206
    1. BMJ. 1999 Jul 10;319(7202):87-90
    1. J Allergy Clin Immunol. 1999 Sep;104(3 Pt 1):547-53
    1. Eur Respir J. 1999 Jul;14(1):12-8
    1. Eur Respir J. 1999 Aug;14(2):275-82

Source: PubMed

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

3
Prenumerera