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Medline ® Abstract for Reference 132

of 'Pharmacotherapy of allergic rhinitis'

132
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Randomized, double-blind, placebo-controlled study of montelukast for treating perennial allergic rhinitis.
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Patel P, Philip G, Yang W, Call R, Horak F, LaForce C, Gilles L, Garrett GC, Dass SB, Knorr BA, Reiss TF
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Ann Allergy Asthma Immunol. 2005;95(6):551.
 
BACKGROUND: Perennial allergic rhinitis (PAR) is a persistent allergic inflammation of the upper respiratory tract due to year-round allergen exposure.
OBJECTIVE: To evaluate the leukotriene receptor antagonist montelukast for the treatment of PAR.
METHODS: Protocol 265 was a 2-arm study performed during the winter. After a placebo run-in period, adults with perennial allergen sensitivity and active symptoms of PAR were randomized to receive 10 mg of montelukast (n=1002) or placebo (n=990) once daily during a 6-week, double-blind, active-treatment period. The primary end point was the daytime nasal symptoms score, defined as the average of scores for nasal congestion, rhinorrhea, and sneezing rated daily by patients.
RESULTS: Statistically significant improvements in PAR symptoms were seen in patients treated with montelukast. Their daytime nasal symptoms scores were reduced during treatment compared with those of theplacebo group: the difference between treatments in least squares mean change from baseline was -0.08 (95% confidence interval [CI], -0.12 to -0.04; P<.001). Montelukast treatment also improved global evaluations of allergic rhinitis by patients and Rhinoconjunctivitis Quality of Life Questionnaire scores: differences vs the placebo group were -0.15 (95% CI, -0.27 to -0.04; P<.01) and -0.15 (95% CI, -0.24 to -0.06; P<.001), respectively. Other end points that showed statistically significant improvement with montelukast treatment were nighttime symptoms and each of the 4 nasal symptoms (congestion, rhinorrhea, sneezing, and itching). The treatment effects of montelukast were stable and persistent during the entire 6 weeks of treatment.
CONCLUSION: Montelukast provided statistically significant relief of PAR symptoms during 6 weeks of treatment.
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Allied Research International, Mississauga, Ontario, Canada. PPatel@allied-research.com
PMID