Efficacy of montelukast for treating perennial allergic rhinitis.
Perennial allergic rhinitis (PAR) is a chronic inflammatory nasal condition in individuals exposed year-round to allergens. This was a double-blind study of 15- to 85-year-old patients randomly allocated to montelukast, 10 mg (n=630), placebo (n=613), or the positive control cetirizine, 10 mg (n=122) for 6 weeks. The primary efficacy end point was change from baseline in Daytime Nasal Symptoms Score (DNSS; mean of congestion, rhinorrhea, sneezing, and itching scores, rated daily by patients [scale: 0=none to 3=severe]) averaged during the initial 4 weeks (primary analysis) or entire 6 weeks of treatment. Also assessed were combined post hoc results of primary end point data from this study and another similarly designed study (Patel P, et al. Randomized, double-blind, placebo-controlled study of montelukast for treating perennial allergic rhinitis, Ann Allergy Asthma Immunol 95:551, 2005). Over 4 weeks, montelukast showed numerical improvement over placebo in DNSS (least-squares mean difference of -0.04 [95% confidence interval (CI}, -0.09, 0.01]); the difference between cetirizine and placebo was significant: -0.10 (95% CI, -0.19, -0.01). However, when averaged over 6 weeks, neither active treatment was significantly different from placebo. The Rhinoconjunctivitis Quality-of-Life score was significantly improved by montelukast (p < 0.05), but not by cetirizine, during 4 and 6 weeks. The treatment effect of montelukast, but not cetirizine, generally remained consistent through the 6 weeks of treatment. In pooled data, montelukast consistently improved DNSS versus placebo during all 6 weeks of treatment (-0.07 [95% CI, -0.10, -0.041). In conclusion, montelukast produced numerical improvement in daytime nasal symptoms and significant improvement in quality of life. In a pooled post hoc analysis, montelukast provided consistent improvement in daytime nasal symptoms over 6 weeks, supportive of an overall benefit in PAR.
Philip
George
G
Merck Research Laboratories, Respiratory & Allergy Department, Rahway, NJ 07065, USA. george_philip@merck.com
Williams-Herman
Debora
D
Patel
Piyush
P
Weinstein
Steven F
SF
Alon
Achilles
A
Gilles
Leen
L
Tozzi
Carol A
CA
Dass
S Balachandra
SB
Reiss
Theodore F
TF
D000085:Acetates / Q000008:administration & dosage / Q000627:therapeutic use*; D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001249:Asthma / Q000188:drug therapy*; D017332:Cetirizine / Q000008:administration & dosage / Q000627:therapeutic use; D003521:Cyclopropanes; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D020024:Leukotriene Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D014663:Nasal Decongestants / Q000008:administration & dosage / Q000494:pharmacology; D009666:Nose / Q000098:blood supply; D011804:Quinolines / Q000008:administration & dosage / Q000627:therapeutic use*; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy* / Q000503:physiopathology; D013440:Sulfides; D014661:Vasoconstriction / Q000502:physiology
D000085:Acetates; D003521:Cyclopropanes; D020024:Leukotriene Antagonists; D014663:Nasal Decongestants; D011804:Quinolines; D013440:Sulfides; C093875:montelukast; D017332:Cetirizine