Improving asthma control in patients suboptimally controlled on inhaled steroids and long-acting beta2-agonists: addition of montelukast in an open-label pilot study.
BACKGROUND
Airway inflammation and symptoms often persist in asthma patients despite treatment with inhaled corticosteroids (ICS) and long-acting beta2-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 (> or = 15 years old) suffering from persistent asthma (pre-bronchodilator FEV1 > or = 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 (kappa = 0.66).


CONCLUSIONS
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.
Dupont
Lieven
L
Department of Respiratory Diseases, UZ Gasthuisberg, Katholieke Universiteit Leuven, Herestraat 49, 3000 Leuven, Belgium. lieven.dupont@uz.kuleuven.ac.be
Potvin
Emmanuel
E
Korn
Dana
D
Lachman
Albert
A
Dramaix
Michèle
M
Gusman
Julie
J
Peché
Rudi
R
D000085:Acetates / Q000008:administration & dosage / Q000627:therapeutic use*; D000280:Administration, Inhalation; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000627:therapeutic use*; D000318:Adrenergic beta-Agonists / Q000008:administration & dosage / Q000627:therapeutic use*; D000328:Adult; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001530:Belgium; D003521:Cyclopropanes; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011804:Quinolines / Q000008:administration & dosage / Q000627:therapeutic use*; D013440:Sulfides; D011795:Surveys and Questionnaires
D000085:Acetates; D000305:Adrenal Cortex Hormones; D000318:Adrenergic beta-Agonists; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; C093875:montelukast