Improving asthma control in patients suboptimally controlled on inhaled steroids and long-acting β2-agonists: addition of montelukast in an open-label pilot study

Authors: Dupont, Lieven¹; Potvin, Emmanuel²; Korn, Dana³; Lachman, Albert⁴; Dramaix, Michèle⁵; Gusman, Julie⁶; Peché, Rudi⁷

Source: Current Medical Research and Opinion, Volume 21, Number 6, June 2005 , pp. 863-870(8)

Publisher: Informa Healthcare

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Abstract:

Background: Airway inflammation and symptoms often persist in asthma patients despite treatment with inhaled corticosteroids (ICS) and long-acting β₂ -agonists (LABA). It is hypothesized that the leukotriene receptor antagonist montelukast, treating a pathway of inflammation distinct from that of ICS, might confer additional benefit.

Objective: To evaluate the efficacy of montelukast in improving asthma control in patients symptomatic on a fixed-association (FA) medium dose of ICS and LABA.

Methods: A 2-month, open-label, real-life observational study was undertaken by 131 Belgian pulmonologists. Patients (≥ 15 years old) suffering from persistent asthma (pre-bronchodilator FEV₁ ≥ 60% of predicted value) and insufficiently controlled on a FA therapy of fluticasone/salmeterol or budesonide/formoterol were given montelukast 10 mg daily as add-on therapy. Asthma control was assessed by the standardized Juniper asthma control questionnaire (ACQ) at baseline and after a 2-month treatment with montelukast. Global evaluation of therapy was made both by the patients and physicians.

Results: A total of 313 patients were eligible for analysis. Forty-nine per cent received inhaled fluticasone/salmeterol and the rest budesonide/formoterol. Mean ACQ score decreased significantly on montelukast (13.9 ± 5.1 at baseline versus 7.4 ± 4.7 on montelukast, p < 0.001), with a significant improvement in all individual symptom scores (p < 0.001) and in pre-bronchodilator FEV₁ score (from 2.2 ± 1.5 to 1.6 ± 1.4; p < 0.001). Parallel to these results, 78.6% of the patients reported a global improvement of their asthma. The same proportion of improvement was observed in the global evaluation made by the physicians (κ = 0.66).

Conclusion: This pilot study suggests that addition of montelukast in patients symptomatic on a FA of ICS and LABA may result in significant improvements in asthma control. A randomised, placebo-controlled clinical trial seems warranted.

Keywords: ASTHMA CONTROL; FIXED ASSOCIATION; MONTELUKAST

Document Type: Case report

DOI: 10.1185/030079905X46304

Affiliations: 1: Department of Respiratory Diseases, UZ Gasthuisberg, Katholieke Universiteit Leuven, Herestraat 49, 3000 Leuven, Belgium 2: Department of Respiratory Diseases, AZ St Augustinus, Oosterveldlaan 24, 2610 Wilrijk, Belgium 3: Department of Respiratory Diseases, CHU Brugmann, Rue du Foyer Schaerbeekois 36, 1030 Brussels, Belgium 4: Department of Respiratory Diseases, Molière-Longchamp Hospital, Rue Marconi 142, 1180 Brussels, Belgium 5: Department of Statistics, Faculty of Medicine, Free University of Brussels, Route de Lennik 808, 1070 Brussels, Belgium 6: Medical Department, Merck Sharp & Dohme, Boulevard de Waterloo 1135, 1180 Brussels, Belgium 7: Department of Respiratory Diseases, CHU VESALE, Route de Gozée 706, 6110 Montigny-le-Tilleul, Belgium

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