ASTHMA

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

M J Vaquerizo¹, P Casan², J Castillo³, M Perpiña⁴, J Sanchis², V Sobradillo⁵, A Valencia⁶, H Verea⁷, J L Viejo⁸, C Villasante⁹, J Gonzalez-Esteban¹, C Picado¹⁰ for the CASIOPEA (CApacidad de SIngulair Oral en la Prevencion de Exacerbaciones Asmaticas) Study Group^*

¹ Merck Sharp & Dohme, Madrid, Spain
² Department of Pneumology, H Santa Creu i Sant Pau, Barcelona, Spain
³ Pneumology and Thoracic Surgery Unit, H Virgen del Rocío, Sevilla, Spain
⁴ Department of Pneumology, H Universitario La Fe, Valencia, Spain
⁵ Department of Pneumology, H de Cruces, Vizcaya, Spain
⁶ Department of Pneumology, H Carlos Haya, Málaga, Spain
⁷ Department of Pneumology, H Juan Canalejo, La Coruña, Spain
⁸ Department of Pneumology, H General Yagüe, Burgos, Spain
⁹ Department of Pneumology, H Universitario La Paz, Madrid, Spain
¹⁰ Department of Pneumology, H Clínico y Provincial, Barcelona, Spain

Correspondence to:
Correspondence to:
Dr M J Vaquerizo, Merck Sharp & Dohme, c/ Josefa Valcarcel 38, 28027 Madrid, Spain;
maria_jose_vaquerizo{at}merck.com

Background: Proinflammatory leukotrienes, which are not completely inhibited by inhaled corticosteroids, may contribute to asthmatic problems. 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 (FEV₁) 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 µg/day) by Turbuhaler throughout the study.

Results: Mean FEV₁ 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 ß 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.

Keywords: asthma; montelukast; budesonide; add-on therapy; leukotriene receptor antagonists

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