Table 4.

Randomized controlled trials with antileukotrienes

Type of CU	Patients treated	Drugs	Results	Outcome	Study	Category of evidence	Grade of recommendation	Reference
ASA- and/or food additives-induced urticaria	51	Montelukast 10 mg once a day vs cetirizine 10 mg once a day vs placebo	Montelukast controls urticaria symptoms better than cetirizine and placebo	Favorable	RTC	IIb	C	41
Healthy subjects affected by COX inhibitorinduced urticaria	10	Montelukast 10 mg once a day vs placebo before the challenge with ibuprofen	A complete blockade reaction in 3 patients, a partial blockade in 6, no effect in 1	Favorable	RTC	IIb	C	42
CU refractory to H1 antagonist monotherapy	95	Cetirizine 10 mg once a day plus zafirlukast 20 mg twice daily vs cetirizine 10 mg once a day plus placebo	Combination therapy (cetirizine plus zafirlukast) better than cetirizine plus placebo only in ASST-positive patients	Favorable	RTC	IIb	C	43
CU refractory	30	Montelukast 10 mg once a day vs placebo using cetirizine 10 mg as needed	montelukast controls urticaria symptoms better than placebo	Favorable	RTC	IIb	C	44
Hetergeneous population of CU	52	zafirlukast 20 mg twice daily vs placebo	No significant effect for any of the efficacy measures	Unfavorable	RTC	IIb	C	45
Mild CU	76	Desloratadine 5 mg once a day vs desloratadine 5 mg once a day plus montelukast 10 mg a day vs placebo	Combination therapy (desloratadine plus montelukast) better than desloratadine alone and placebo	Favorable	RTC	IIb	C	46
Moderate CIU	160	montelukast 10 mg once a day vs montelukast 10 mg once a day plus desloratadine 5 mg once a day vs desloratadine 5 mg once a day vs placebo	montelukast alone less effective than the combination with desloratadine and not useful in controlling urticaria compared with desloratadine alone	Unfavorable	RTC	IIb	C	47