Comparison of fluticasone propionate aqueous nasal spray and oral montelukast for the treatment of seasonal allergic rhinitis symptoms.
Level 2 - randomized trial
Individual randomized controlled trial
PubMed 16802774 · doi:10.1016/S1081-1206(10)61349-X
What was done
A double-blind, double-dummy, parallel-group randomized controlled trial compared fluticasone propionate aqueous nasal spray (200 microg daily, n = 367) with oral montelukast (10 mg daily, n = 369) in patients aged 15 years or older with seasonal allergic rhinitis over 2 weeks. The primary efficacy measure was mean change from baseline in daytime total nasal symptom scores (TNSSs, summing congestion, itching, rhinorrhea, and sneezing) averaged across weeks 1 and 2. Secondary endpoints included individual daytime symptom scores, nighttime TNSSs (congestion on awakening, difficulty falling asleep, nighttime awakenings), and individual nighttime symptom scores.
What was found
No numerical values, baseline scores, or absolute mean changes are reported in the abstract. Compared with montelukast, fluticasone propionate produced statistically significant greater improvements across 2 weeks in daytime TNSSs (P < .001), all daytime individual scores (P < .001), nighttime TNSSs (P < .001), and all nighttime individual scores (P <= .02).
Why it matters
This direct head-to-head trial shows that an intranasal corticosteroid provides superior control over an oral leukotriene receptor antagonist for both daytime and nighttime seasonal allergic rhinitis symptoms.
Limits
The study duration was only 2 weeks, so long-term outcomes remain unknown. Patients younger than 15 years were excluded. The abstract omits effect sizes, baseline scores, confidence intervals, and safety/adverse event outcomes.
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