Efficacy of add-on montelukast in patients with non-controlled asthma: a Belgian open-label study^*

ABSTRACT

Objective: To evaluate the efficacy of add-on montelukast on asthma control and allergic rhinitis symptoms in asthmatic patients still symptomatic with chronic treatment with inhaled corticosteroid and long-acting β₂ agonist (ICS/LABA), irrespective of the dose.

Research design and methods: This 2-month, open-label, real-life, multicentre, observational study was undertaken by 499 general practitioners in Belgium. Patients (≥ 4 years old) with uncontrolled asthma despite fluticasone/salmeterol or budesonide/formoterol therapy had oral montelukast 4, 5, or 10 mg daily added to their therapy, depending on the registered dose for their age. Asthma control, assessed by the 6-item Juniper Asthma Control Questionnaire (ACQ) was recorded at baseline and after 2 months of treatment with montelukast and the patients’ global evaluation of asthma was also recorded at the end of the study. Concomitant allergic rhinitis symptoms were evaluated according to the patients’ perception.

Results: A total of 5769 patients were eligible for analysis. Addition of montelukast was associated with significant decrease in mean (SD) ACQ score (from 1.97 [0.77] at baseline to 1.05 [0.69] after add-on treatment, p < 0.001). There was also a significant improvement in all individual symptoms of the ACQ score (p < 0.001). After 2 months, 89% of the patients reported global improvement of their asthma, with a good correlation between patients’ global evaluation and change in ACQ scores. Of the 2442 patients who reported allergic rhinitis symptoms at baseline, 91% showed a global improvement of their asthma symptoms and 82% in their rhinitis symptoms after adding montelukast.

Conclusion: This open-label observational study showed an improvement, after 2 months of add-on therapy with montelukast, in both asthma and allergic rhinitis symptoms in patients not adequately controlled on a fixed association of ICS/LABA.

Key words: :

• Allergic rhinitis
• Asthma
• Fixed associations
• Montelukast

Acknowledgements

Declaration of interest: This study was supported by a grant from MSD Belgium. E. H. is an employee of MSD. None of the other authors has a conflict of interest to declare. Editorial assistance was provided by Michelle Hughes (Freelance Medical Writer, Cheshire, UK), funded by MSD.

Notes

* Presented in part at the ERS (European Respiratory Society meeting), Munich, Germany, 2–6 September, 2006, and the ATS (American Thoracic Society meeting), San Diego, USA, 19–24 May, 2006