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Preventive effect of nasal filters on allergic rhinitis: A randomized, double-blind, placebo-controlled crossover park study - 04/12/15

Doi : 10.1016/j.jaci.2015.05.015 
Peter Kenney, BSc a, b, Ole Hilberg, MD, DMSci c, Anne Cathrine Laursen, BSc d, Robert George Peel, PhD e, Torben Sigsgaard, MD, PhD a,
a Department of Public Health, Section for Environment, Occupation and Health, Aarhus University, Aarhus, Denmark 
b Rhinix ApS, Aarhus, Denmark 
c Department of Respiratory Diseases and Allergology, Aarhus University Hospital, Aarhus, Denmark 
d Aarhus University, Aarhus, Denmark 
e Department of Environmental Science, Aarhus University, Roskilde, Denmark 

Corresponding author: Torben Sigsgaard, MD, PhD, Department of Public Health, Section for Environment, Occupation and Health, Aarhus University, Bartholins Allé 2, Building 1260, 8000 Aarhus C, Denmark.

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).
 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.


© 2015  American Academy of Allergy, Asthma & Immunology. Publicado por Elsevier Masson SAS. Todos los derechos reservados.
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Vol 136 - N° 6

P. 1566 - décembre 2015 Regresar al número
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