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The effect of montelukast on rhinitis symptoms in patients with asthma and seasonal allergic rhinitis.

Abstract

OBJECTIVE

The objective of this study was to evaluate montelukast 10 mg daily as treatment for allergic rhinitis in patients with symptomatic allergic rhinitis and active asthma during the allergy season.

METHODS

This was a multicenter study of 831 patients (ages 15 years-85 years) with seasonal allergen sensitivity, active symptoms of seasonal allergic rhinitis, and active asthma. Following a single-blind, placebo run-in period of 3 days-5 days, patients were randomized to oral montelukast 10 mg (n = 415) or placebo (n = 416) daily during the 2-week, double-blind, active-treatment period.

MAIN OUTCOME MEASURES

The primary endpoint was Daily Rhinitis Symptoms score, average of Daytime Nasal Symptoms and Nighttime Symptoms, as self-rated by patients on a 0-3 scale on daily diaries.

RESULTS

Montelukast reduced the Daily Rhinitis Symptoms score: difference between montelukast and placebo in mean change from baseline was -0.12 [95% CI -0.18, -0.06; p < or = 0.001]. Similar improvements were seen in Daytime Nasal Symptoms (-0.14 [-0.21, -0.07; p < or = 0.001]) and Nighttime Symptoms (-0.10 [-0.16, -0.04; p < or = 0.001]). Improvements (p < 0.05) were seen in Daytime Eye Symptoms and in the secondary endpoints of Global Evaluations of AR by Patient and by Physician, and Rhinoconjunctivitis Quality of Life. In exploratory analyses, improvement in rhinitis symptoms was numerically (though not statistically) larger in patients with greater levels of asthma at study start. Montelukast provided benefit in the Global Evaluations of Asthma by Patient and by Physician: mean differences were -0.24 [-0.41, -0.06; p = 0.008] and -0.17 [-0.33, -0.01; p = 0.037]. Similarly, as-needed beta-agonist use (puffs/day) was reduced with montelukast (p < or = 0.005).

CONCLUSION

Montelukast provides significant relief from symptoms of seasonal allergic rhinitis, while also conferring a benefit for asthma, in patients with both allergic rhinitis and asthma.

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  • Authors+Show Affiliations

    ,

    Merck Research Laboratories, Rahway, NJ, USA.

    , , , , ,

    Source

    Current medical research and opinion 20:10 2004 Oct pg 1549-58

    MeSH

    Acetates
    Adolescent
    Adult
    Aged
    Aged, 80 and over
    Anti-Asthmatic Agents
    Asthma
    Double-Blind Method
    Female
    Humans
    Male
    Middle Aged
    Quinolines
    Rhinitis, Allergic, Seasonal
    Single-Blind Method
    Treatment Outcome

    Pub Type(s)

    Clinical Trial
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    15462688

    Citation

    Philip, George, et al. "The Effect of Montelukast On Rhinitis Symptoms in Patients With Asthma and Seasonal Allergic Rhinitis." Current Medical Research and Opinion, vol. 20, no. 10, 2004, pp. 1549-58.
    Philip G, Nayak AS, Berger WE, et al. The effect of montelukast on rhinitis symptoms in patients with asthma and seasonal allergic rhinitis. Curr Med Res Opin. 2004;20(10):1549-58.
    Philip, G., Nayak, A. S., Berger, W. E., Leynadier, F., Vrijens, F., Dass, S. B., & Reiss, T. F. (2004). The effect of montelukast on rhinitis symptoms in patients with asthma and seasonal allergic rhinitis. Current Medical Research and Opinion, 20(10), pp. 1549-58.
    Philip G, et al. The Effect of Montelukast On Rhinitis Symptoms in Patients With Asthma and Seasonal Allergic Rhinitis. Curr Med Res Opin. 2004;20(10):1549-58. PubMed PMID: 15462688.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - The effect of montelukast on rhinitis symptoms in patients with asthma and seasonal allergic rhinitis. AU - Philip,George, AU - Nayak,Anjuli S, AU - Berger,William E, AU - Leynadier,Francisque, AU - Vrijens,France, AU - Dass,S Balachandra, AU - Reiss,Theodore F, PY - 2004/10/7/pubmed PY - 2005/2/8/medline PY - 2004/10/7/entrez SP - 1549 EP - 58 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 20 IS - 10 N2 - OBJECTIVE: The objective of this study was to evaluate montelukast 10 mg daily as treatment for allergic rhinitis in patients with symptomatic allergic rhinitis and active asthma during the allergy season. METHODS: This was a multicenter study of 831 patients (ages 15 years-85 years) with seasonal allergen sensitivity, active symptoms of seasonal allergic rhinitis, and active asthma. Following a single-blind, placebo run-in period of 3 days-5 days, patients were randomized to oral montelukast 10 mg (n = 415) or placebo (n = 416) daily during the 2-week, double-blind, active-treatment period. MAIN OUTCOME MEASURES: The primary endpoint was Daily Rhinitis Symptoms score, average of Daytime Nasal Symptoms and Nighttime Symptoms, as self-rated by patients on a 0-3 scale on daily diaries. RESULTS: Montelukast reduced the Daily Rhinitis Symptoms score: difference between montelukast and placebo in mean change from baseline was -0.12 [95% CI -0.18, -0.06; p < or = 0.001]. Similar improvements were seen in Daytime Nasal Symptoms (-0.14 [-0.21, -0.07; p < or = 0.001]) and Nighttime Symptoms (-0.10 [-0.16, -0.04; p < or = 0.001]). Improvements (p < 0.05) were seen in Daytime Eye Symptoms and in the secondary endpoints of Global Evaluations of AR by Patient and by Physician, and Rhinoconjunctivitis Quality of Life. In exploratory analyses, improvement in rhinitis symptoms was numerically (though not statistically) larger in patients with greater levels of asthma at study start. Montelukast provided benefit in the Global Evaluations of Asthma by Patient and by Physician: mean differences were -0.24 [-0.41, -0.06; p = 0.008] and -0.17 [-0.33, -0.01; p = 0.037]. Similarly, as-needed beta-agonist use (puffs/day) was reduced with montelukast (p < or = 0.005). CONCLUSION: Montelukast provides significant relief from symptoms of seasonal allergic rhinitis, while also conferring a benefit for asthma, in patients with both allergic rhinitis and asthma. SN - 0300-7995 UR - https://www.unboundmedicine.com/medline/citation/15462688/The_effect_of_montelukast_on_rhinitis_symptoms_in_patients_with_asthma_and_seasonal_allergic_rhinitis_ L2 - http://www.tandfonline.com/doi/full/10.1185/030079904X3348 DB - PRIME DP - Unbound Medicine ER -