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Randomized, double-blind, placebo-controlled study of montelukast for treating perennial allergic rhinitis
Piyush Patel1, George Philip, William Yang
1Allied Research International, Mississauga, Ontario, Canada. PPatel@allied-research.com
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 the placebo 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.
Insights
Montelukast significantly improved perennial allergic rhinitis (PAR) symptoms, including nasal congestion and sneezing. This leukotriene receptor antagonist offers a 6-week treatment option for persistent allergic rhinitis relief.
Area of Science:
- Allergy and Immunology
- Pharmacology
Background:
- Perennial allergic rhinitis (PAR) involves chronic upper respiratory inflammation due to year-round allergens.
- Effective treatments for persistent PAR symptoms are crucial for improving patient quality of life.
Purpose of the Study:
- To assess the efficacy of montelukast, a leukotriene receptor antagonist, in treating perennial allergic rhinitis.
- Evaluate montelukast's impact on key PAR symptom scores and quality of life.
Main Methods:
- A 6-week, double-blind, placebo-controlled study randomized 1002 patients to montelukast (10 mg daily) and 990 to placebo.
- The primary endpoint was the change in daytime nasal symptom scores (congestion, rhinorrhea, sneezing).
- Secondary endpoints included nighttime symptoms, global evaluations, and quality of life scores.
Main Results:
- Montelukast significantly reduced daytime nasal symptom scores compared to placebo (mean difference -0.08, P < .001).
- Patients receiving montelukast reported improved global evaluations and quality of life (Rhinoconjunctivitis Quality of Life Questionnaire scores).
- Significant improvements were observed in nighttime symptoms and all individual nasal symptoms, with sustained effects over 6 weeks.
Conclusions:
- Montelukast demonstrates statistically significant efficacy in relieving perennial allergic rhinitis symptoms over a 6-week treatment period.
- The study supports montelukast as an effective therapeutic option for managing persistent allergic rhinitis.
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