A comparison of topical budesonide and oral montelukast in seasonal allergic rhinitis and asthma


B. J. Lipworth, Professor of Allergy and Respiratory Medicine, Department of Clinical Pharmacology & Therapeutics, Ninewells Hospital & Medical School, University of Dundee, Dundee DD1 9SY, UK. E-mail: b.j.lipworth@dundee.ac.uk


Background Allergic rhinitis and asthma commonly coexist and are both mediated by similar inflammatory mechanisms. Leukotriene antagonists may therefore be an alternative to corticosteroid therapy.

Objective To compare oral montelukast with inhaled plus intranasal budesonide in patients with seasonal allergic rhinitis and asthma.

Patients and methods A single-blind double-dummy placebo-controlled crossover study was performed comparing once daily 10 mg oral montelukast with 400 µg inhaled plus 200 µg intranasal budesonide in 12 patients with allergic rhinitis and asthma: mean (S.E.) age 34.0 years (2.7), forced expiratory volume in 1 s (FEV1) 91.2 (3.8)% predicted. Each treatment was for 2 weeks with a 1-week placebo run-in and washout. Measurements were made after each active treatment and placebo for: adenosine monophosphate bronchial challenge, exhaled and nasal nitric oxide. Patients also recorded their domiciliary peak expiratory flow, nasal peak inspiratory flow, asthma and seasonal allergic rhinitis symptoms.

Results There were no significant differences between the placebos for any measurement. For adenosine monophosphate PC20, geometric mean fold differences (95% confidence interval (CI) for difference) were 6.4 (2.2–18.6) for placebo vs. budesonide, 2.9 (1.0–8.4) for placebo vs. montelukast, and 2.1 (1.1–4.5) for budesonide vs. montelukast. For exhaled nitric oxide (p.p.b.) there was significant (P < 0.05) suppression with both montelukast (10.9) and budesonide (10.1) compared with placebo (18.8). For nasal nitric oxide and nasal peak flow there were only significant differences with budesonide compared with placebo. Both treatments reduced total seasonal allergic rhinitis symptoms but only budesonide had a significant effect on nasal symptoms.

Conclusion Once-daily inhaled plus intranasal budesonide and once daily montelukast showed comparable efficacy on lower airway, but only the budesonide had significant efficacy on upper airway inflammatory markers. Both treatments significantly reduced allergic rhinitis symptoms.