- Leukotriene receptor antagonists versus placebo in people using ICS:
- A systematic review (search date October 2003, 27 RCTs, only two trials included children) showed that addition of a leukotriene receptor antagonist to ICS reduced the risk of exacerbations requiring systemic steroids (not statistically significant), reduced use of rescue short-acting beta2-agonists (by 1 puff/week), and improved peak expiratory flow rate (by 7.7 mL/min). Only three trials compared addition of leukotriene receptor antagonists with increasing the inhaled steroid dose, and no conclusions can be made [Ducharme et al, 2004].
- An RCT (n = 455 adults) with asthma and skin-test sensitivity to seasonal aeroallergens were randomized to receive oral montelukast 10 mg vs. placebo for 3 weeks during the allergy season. The reduction in daytime asthma symptom score (total 6 points) was 0.54 points with montelukast and 0.34 points with placebo, a statistically significant (p = 0.002) but not clinically relevant difference [Busse et al, 2006].
- An RCT (n = 689 children aged 2–5 years) showed that 12 weeks of montelukast, 4 mg once daily, was more effective than once-daily chewable placebo tablets at improving daytime asthma symptoms (59% vs. 64% days with asthma symptoms), nocturnal cough, and use of beta2-agonists (49% vs. 55% days with beta-agonist use) and use of oral steroids. No significant adverse effects were reported [Knorr et al, 2001].
- Leukotriene receptor antagonist versus doubling the dose of ICS:
- An RCT (n = 889 people aged 15–75 years) showed that addition of montelukast (10 mg once daily) and doubling the dose of budesonide were equally effective strategies in people whose asthma was inadequately controlled with budesonide, 800 micrograms/day, over 12 weeks. Both groups improved, and more rapid response was reported in the montelukast group, but this finding was based on peak flow measurements. The groups did not significantly differ in symptom-based outcomes. The study was funded by the manufacturer of montelukast [Rodolfo et al, 2005].
- Leukotriene receptor antagonist alone versus ICS alone:
- One systematic review (search date 2003, 15 RCTs in adults and three RCTs in children, n = 4965) found that leukotriene receptor antagonists were significantly less effective than ICS (beclometasone and fluticasone) in reducing risk of exacerbation requiring oral corticosteroids and reducing symptom-free days over 4 to 37 weeks. There was no difference in hospital admission rates for exacerbations [Rodolfo et al, 2005].
- Leukotriene receptor antagonists alone versus ICS plus LABA:
- Two RCTs (n = 855 adults) showed that fluticasone (200 micrograms/day) plus salmeterol (50 mg/day) compared with montelukast (10 mg/day) significantly increased symptom-free days, reduced exacerbations, and improved lung function and symptoms at 12 weeks [Rodolfo et al, 2005].
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