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document
Randomized controlled trial evaluating the clinical benefit of montelukast for treating spring seasonal allergic rhinitis . BACKGROUND Symptoms of allergic rhinitis are mediated in part by cysteinyl leukotrienes . OBJECTIVE To evaluate the clinical benefit of montelukast , a cysteinyl leukotriene receptor antagonist , administered once daily for treating seasonal allergic rhinitis . METHODS This multicenter , randomized , double-blind , placebo- and active-controlled study enrolled 1,214 healthy , nonsmoking outpatients aged 15 to 85 years with spring allergic rhinitis , positive skin test to a spring allergen , and predefined daytime nasal symptoms . After a 3- to 5-day placebo run-in period , patients were randomly assigned to treatment with montelukast 10 mg ( n = 522 ) , loratadine 10 mg ( n = 171 ) , or placebo ( n = 521 ) once daily at bedtime for 2 weeks . During the run-in and treatment periods , symptoms were evaluated in a daily diary using a 0 ( best ) to 3 ( worst ) scale . RESULTS Baseline characteristics of randomized patients were clinically similar in the three treatment groups . Montelukast was significantly more effective than placebo ( P = 0.003 ) in improving the daytime nasal symptoms score ( difference in least square means , -0.09 ; 95 % confidence interval , -0.16 , -0.03 ) averaged over 2 weeks of therapy . The treatment effect of montelukast was significantly greater ( P < 0.05 ) , relative to placebo , for all secondary endpoints , including nighttime symptoms and daytime eye symptoms , patient and physician global evaluations of allergic rhinitis , and rhinoconjunctivitis quality of life . Loratadine , which served as a positive control , was significantly more effective than placebo for most endpoints , validating the study results . Both montelukast and loratadine were well tolerated . CONCLUSION Therapy with montelukast significantly improves assessments of symptom severity as well as quality-of-life parameters for patients with seasonal allergic rhinitis .
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Intervention_Pharmacological
montelukast
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Intervention_Pharmacological
cysteinyl leukotriene receptor antagonist
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Intervention_Control
placebo-
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Intervention_Control
placebo
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Intervention_Pharmacological
montelukast
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Intervention_Pharmacological
loratadine
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Intervention_Control
placebo
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Intervention_Pharmacological
Montelukast
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Intervention_Control
placebo
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Intervention_Pharmacological
montelukast
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Intervention_Pharmacological
Loratadine
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Intervention_Pharmacological
montelukast
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Intervention_Pharmacological
loratadine
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Intervention_Pharmacological
montelukast
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Outcome_Physical
spring seasonal allergic rhinitis
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Outcome_Physical
seasonal allergic rhinitis
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Outcome_Mental
symptoms
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Outcome_Physical
daytime nasal symptoms score
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Outcome_Physical
nighttime symptoms and daytime eye symptoms
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Outcome_Physical
patient and physician global evaluations of allergic rhinitis
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Outcome_Physical
rhinoconjunctivitis quality of life
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Outcome_Other
well tolerated
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Outcome_Physical
symptom severity
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Outcome_Physical
quality-of-life parameters
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Participant_Age
enrolled 1,214 healthy , nonsmoking outpatients aged 15 to 85 years with spring allergic rhinitis , positive skin test to a spring allergen , and predefined daytime nasal symptoms .