The Journal of allergy and clinical immunology · 2015
Preventive effect of nasal filters on allergic rhinitis: A randomized, double-blind, placebo-controlled crossover park study.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Kenney Peter, Hilberg Ole, Laursen Anne Cathrine, Peel Robert George, Sigsgaard Torben
Аннотация
BACKGROUND: A recently reported small, out-of-season environmental exposure unit study found nasal filters to be efficacious in preventing seasonal allergic rhinitis (AR). However, nasal filters still need to show efficacy in a natural setting in a regular pollen season.
OBJECTIVE: We sought to evaluate the efficacy of nasal filters (Rhinix; Rhinix ApS, Aarhus, Denmark) for the prevention of symptoms related to seasonal AR.
METHODS: The trial was a single-center, randomized (1:1), double-blind, placebo-controlled crossover clinical trial (NCT02108574) conducted over 2 days in the main grass pollen season in June 2014 in Aarhus, Denmark, on 65 adults with proven grass allergy. A total nasal symptom score (TNSS) consisting of blocked nose, runny nose, nasal itching, and sneezing was used to evaluate symptoms. The difference in daily∑ TNSS (the sum of 13 ratings) was the primary outcome measure. The difference in maximum TNSS (highest score, 13 ratings) was also evaluated.
RESULTS: The nasal filters significantly reduced daily∑ TNSSs (P = .03) and maximum TNSSs (P = .03) compared with placebo. Median relative reductions were 40% for daily∑ TNSSs (P = .02), 43% for maximum TNSSs (P = .004), 83% for daily∑ sneezing (P = .001), 75% for daily∑ watery eyes (P = .02), and 53% for daily∑ runny nose (P = .005) when compared with placebo. The nasal filters were well tolerated, and no serious adverse events were recorded.
CONCLUSION: Statistically significant and clinically relevant reductions were achieved for the primary outcome measure of daily∑ TNSS, for maximum TNSS and for a subset of individual symptoms. The results support the preventive role of nasal filters for managing seasonal AR.
OBJECTIVE: We sought to evaluate the efficacy of nasal filters (Rhinix; Rhinix ApS, Aarhus, Denmark) for the prevention of symptoms related to seasonal AR.
METHODS: The trial was a single-center, randomized (1:1), double-blind, placebo-controlled crossover clinical trial (NCT02108574) conducted over 2 days in the main grass pollen season in June 2014 in Aarhus, Denmark, on 65 adults with proven grass allergy. A total nasal symptom score (TNSS) consisting of blocked nose, runny nose, nasal itching, and sneezing was used to evaluate symptoms. The difference in daily∑ TNSS (the sum of 13 ratings) was the primary outcome measure. The difference in maximum TNSS (highest score, 13 ratings) was also evaluated.
RESULTS: The nasal filters significantly reduced daily∑ TNSSs (P = .03) and maximum TNSSs (P = .03) compared with placebo. Median relative reductions were 40% for daily∑ TNSSs (P = .02), 43% for maximum TNSSs (P = .004), 83% for daily∑ sneezing (P = .001), 75% for daily∑ watery eyes (P = .02), and 53% for daily∑ runny nose (P = .005) when compared with placebo. The nasal filters were well tolerated, and no serious adverse events were recorded.
CONCLUSION: Statistically significant and clinically relevant reductions were achieved for the primary outcome measure of daily∑ TNSS, for maximum TNSS and for a subset of individual symptoms. The results support the preventive role of nasal filters for managing seasonal AR.