Preventive effect of nasal filters on allergic rhinitis: A randomized, double-blind, placebo-controlled crossover park study - 04/12/15
Abstract |
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.
El texto completo de este artículo está disponible en PDF.Key words : Seasonal allergic rhinitis, nasal filter, placebo controlled, randomized controlled trial, total nasal symptom score, total ocular symptom score, pollen, efficacy, allergen avoidance, prevention
Abbreviations used : AR, Daily∑, SAR, TNSS, TOSS
Esquema
Supported by Rhinix ApS, Aarhus, Denmark, and designed to be consistent with recommendations provided in the US Food and Drug Administration document for clinical development of drug products for allergic rhinitis (Guidance for Industry, US Department of Health and Human Services, US Food and Drug Administration Center for Drug Evaluation and Research, April 2000). |
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Disclosure of potential conflict of interest: P. Kenney is founder and part owner of, is a board member for, has a patent with, has stock/stock options in, and receives a monthly salary from Rhinix ApS. The rest of the authors declare that they have no relevant conflicts of interest. |
Vol 136 - N° 6
P. 1566 - décembre 2015 Regresar al númeroBienvenido a EM-consulte, la referencia de los profesionales de la salud.
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