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This article has a correction

Please see: Thorax 2003;58:370

Thorax 2003;58:204-210 doi:10.1136/thorax.58.3.204
  • Asthma

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

  1. M J Vaquerizo1,
  2. P Casan2,
  3. J Castillo3,
  4. M Perpiña4,
  5. J Sanchis2,
  6. V Sobradillo5,
  7. A Valencia6,
  8. H Verea7,
  9. J L Viejo8,
  10. C Villasante9,
  11. J Gonzalez-Esteban1,
  12. C Picado10,
  13. for the CASIOPEA (CApacidad de SIngulair Oral en la Prevencion de Exacerbaciones Asmaticas) Study Group*
  1. 1Merck Sharp & Dohme, Madrid, Spain
  2. 2Department of Pneumology, H Santa Creu i Sant Pau, Barcelona, Spain
  3. 3Pneumology and Thoracic Surgery Unit, H Virgen del Rocío, Sevilla, Spain
  4. 4Department of Pneumology, H Universitario La Fe, Valencia, Spain
  5. 5Department of Pneumology, H de Cruces, Vizcaya, Spain
  6. 6Department of Pneumology, H Carlos Haya, Málaga, Spain
  7. 7Department of Pneumology, H Juan Canalejo, La Coruña, Spain
  8. 8Department of Pneumology, H General Yagüe, Burgos, Spain
  9. 9Department of Pneumology, H Universitario La Paz, Madrid, Spain
  10. 10Department of Pneumology, H Clínico y Provincial, Barcelona, Spain
  1. Correspondence to:
    Dr M J Vaquerizo, Merck Sharp & Dohme, c/ Josefa Valcarcel 38, 28027 Madrid, Spain;
    maria_jose_vaquerizo{at}merck.com
  • Accepted 18 November 2002
  • Revised 30 October 2002

Abstract

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 β 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.

Footnotes

  • ↵* A complete list of members of the CASIOPEA Study Group is provided in the Appendix.

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