Inhaled corticosteroids (ICS) are regarded as the first-line treatment in patients with persistent asthma, resulting lung function, bronchial hyperresponsiveness and eosinophilic inflammation significantly improved. Nonetheless, many patients receiving ICS continue to experience asthma symptoms, and both the synthesis and the release of cys-leucotrienes (LTs) are not inhibited completely. Montelukast, a selective cys-LT1 receptor antagonist, has been found to reduce airway eosinophilic inflammation in patient with asthma, and it would then provide additional benefit for symptomatic patients already receiving ICS. Aim: to assess and compare the 6-week efficacy of ICS alone and of ICS+Montelukast on bronchial hyperresponsiveness to MCh and on the LTE4 urine levels in mild-persistent asthma.
After informed consent, 18 mild-persistent atopic (prick test positive for inhalants) asthmatics (18-62y; mean basal FEV1=103.2%pred±15.4sd; mean PD20FEV1 to MCh=89.8mcg±102.6sd) were randomized. Nine subjects received only Fluticasone p. 250mcg o.d. (group FP), and the remaining 9 Fluticasone p. 250mcg o.d. plus Montelukast 10mg o.d. (FP+M), for 6 weeks according to a double-dummy, double-blind design. PD20 FEV1 to MCh and LTE4 urinary levels were assessed in bsln and at the end of treatments. Urine were collected in the morning and processed by an immunoenzimatic method (Cayman Chemical, Mi, USA). Statistics: t test vs basal and between treatments; p< 0.05 accepted.
In tab. 1.
1) unlike ICS, only the addition of Montelukast enables a substantial decrease of urinary LTE4; 2) the LTs-mediated inflammation confirms its relevant role in atopic asthma.
Montelukast provides a consistent additional control on bronchial hyperresponsiveness when added to ICS in mild persistent asthma. Tab,1FEV1 (%pred)MCh (mcg)LTE4 g/ml)FP basal95.1±8.261.2±70.1488.1±290.3FP+M basal98.5±9.1118.5±125.1430.3±288.1FP 6 wks103.2±15.4395.7±109.1*366.6±278.4FP+M6 wks101.2±11.4638.7±155.3§^179.7±126.1°*
p<0.001 vs FPbasal;§
p<0.001 vs FP+M basal;^
p<0.002 vs FP 6 weeks;
R.W. Dal Negro, None.