Montelukast effectively treats the nighttime impact of seasonal allergic rhinitis.
BACKGROUND
Nighttime problems constitute a significant burden on the quality of life of patients with seasonal allergic rhinitis (SAR). The aim of this study was to evaluate the effectiveness of montelukast on nighttime AR symptoms.


METHODS
In seven multicenter, double-blind, parallel-group trials, nighttime problems were assessed as the nighttime symptoms score (NSS), an average of three individual symptom scores: difficulty going to sleep, nighttime awakening, and nasal congestion on awakening (each rated 0 = none to 3 = severe). Patients (aged 15-82 years) were randomized to receive montelukast, 10 mg (n = 1751), placebo (n = 1557), or the positive control loratadine, 10 mg (n = 1616).


RESULTS
In a combined analysis, changes from baseline (mean +/- SE) in NSS were -0.28 +/- 0.01, -0.16 +/- 0.01, and -0.24 +/- 0.01 for the montelukast, placebo, and loratadine groups, respectively. Difference versus placebo in least-squares mean change from baseline were -0.11 (95% confidence interval, -0.14, -0.08; p < or = 0.001) for montelukast and -0.09 (-0.12, -0.06; p < or = 0.001) for loratadine. Strong baseline correlations (R > 0.70; p < 0.001) of NSS and two of its individual symptoms with the sleep domain of the validated Rhinoconjunctivitis Quality of Life Questionnaire support the validity and importance of measuring nighttime morbidity in SAR. Furthermore, a clinically important benefit of montelukast on the nighttime impact of SAR was shown using an analysis anchored on the Patient's Global Evaluation.


CONCLUSIONS
These data underscore the importance of nighttime problems in patients with SAR and the need to treat nighttime symptoms. In these studies, montelukast significantly improved the NSS, a clinically relevant and valid measure in patients with SAR.
Meltzer
Eli O
EO
Allergy and Asthma Medical Group and Research Center, San Diego, CA 92109, USA.
Philip
George
G
Weinstein
Steven F
SF
LaForce
Craig F
CF
Malice
Marie-Pierre
MP
Dass
S Balachandra
SB
Santanello
Nancy C
NC
Reiss
Theodore F
TF
D000085:Acetates / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003521:Cyclopropanes; D004311:Double-Blind Method; D006801:Humans; D020024:Leukotriene Antagonists / Q000627:therapeutic use*; D017336:Loratadine / Q000627:therapeutic use; D008875:Middle Aged; D011788:Quality of Life; D011804:Quinolines / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D012890:Sleep; D013440:Sulfides
D000085:Acetates; D003521:Cyclopropanes; D020024:Leukotriene Antagonists; D011804:Quinolines; D013440:Sulfides; D017336:Loratadine; C093875:montelukast