A 52 week, two period, double blind, multicentre trial during which 1490 patients (15-72 years) whose symptoms remained uncontrolled by inhaled corticosteroids were randomised to add montelukast or salmeterol 1. 20.1% of the patients in the group receiving montelukast and fluticasone had an asthma exacerbation compared with 19.1% in the group receiving salmeterol and fluticasone; the difference was 1% (95% confidence interval -3.1% to 5.0%). Salmeterol and fluticasone significantly increased FEV1 before a agonist was used and morning peak expiratory flow compared with montelukast and fluticasone (least squares mean (SE) change from baseline of 34.59 (1.70) versus 17.73 (1.69), P 0.001). For nocturnal awakenings, change from baseline was -1.68 (0.06) nights per week (montelukast-fluticasone) versus -1.74 (0.06) (salmeterol-fluticasone) with no significant difference. The asthma specific quality of life score significantly improved from baseline for both treatments (P 0.001): the least squares mean (SE) change from baseline was 0.71 (0.04) (montelukast-fluticasone group) versus 0.76 (0.04) (salmeterol-fluticasone group), with no significant difference between the two groups.
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