Rhinix™ Nasal Filters For The Treatment Of Allergic Rhinitis: A Randomized, Double-Blinded Placebo-Controlled Crossover Clinical Trial

Abstract

RationaleNasal filters might be useful as an alternative to current treatments for seasonal allergic rhinitis. The aim of this study was to evaluate the efficacy, safety and usability of Rhinix™ nasal filters in the treatment of seasonal allergic rhinitis.MethodsThe trial was a single-centre, randomized (1:1), double-blinded placebo-controlled crossover clinical trial (NCT01699165) conducted out of season in an Environmental Exposure Unit (EEU) in Aarhus, Denmark on 24 subjects with proven grass allergy. A total nasal symptom score (TNSS) consisting of nasal congestion, nasal discharge, nasal itching and sneezing was used as the primary outcome measure. TNSS was rated 9 times during each study day and evaluated based on the difference in daily TNSS (the sum of all 9 ratings) and maximum TNSS (the highest score of the 9).ResultsRhinix™ reduced daily TNSS by 21% (P=0.049), daily sneezing by 45% (P=0.01), maximum itching by 46% (P=0.004) and maximum sneezing by 38% (P=0.001) when compared to placebo. Rhinix™ failed to show a significant reduction in the primary efficacy endpoint of difference in maximum TNSS (P=0.14) with a mean reduction of 14% and median reduction of 33% when compared to placebo. The nasal filters were well tolerated and no serious adverse events were recorded.ConclusionsAlthough maximum TNSS showed no statistically significant difference, statistically significant and clinically relevant reductions were achieved with Rhinix™ nasal filters in daily TNSS as well as in a subset of individual symptoms for patients with seasonal allergic rhinitis. RationaleNasal filters might be useful as an alternative to current treatments for seasonal allergic rhinitis. The aim of this study was to evaluate the efficacy, safety and usability of Rhinix™ nasal filters in the treatment of seasonal allergic rhinitis. Nasal filters might be useful as an alternative to current treatments for seasonal allergic rhinitis. The aim of this study was to evaluate the efficacy, safety and usability of Rhinix™ nasal filters in the treatment of seasonal allergic rhinitis. MethodsThe trial was a single-centre, randomized (1:1), double-blinded placebo-controlled crossover clinical trial (NCT01699165) conducted out of season in an Environmental Exposure Unit (EEU) in Aarhus, Denmark on 24 subjects with proven grass allergy. A total nasal symptom score (TNSS) consisting of nasal congestion, nasal discharge, nasal itching and sneezing was used as the primary outcome measure. TNSS was rated 9 times during each study day and evaluated based on the difference in daily TNSS (the sum of all 9 ratings) and maximum TNSS (the highest score of the 9). The trial was a single-centre, randomized (1:1), double-blinded placebo-controlled crossover clinical trial (NCT01699165) conducted out of season in an Environmental Exposure Unit (EEU) in Aarhus, Denmark on 24 subjects with proven grass allergy. A total nasal symptom score (TNSS) consisting of nasal congestion, nasal discharge, nasal itching and sneezing was used as the primary outcome measure. TNSS was rated 9 times during each study day and evaluated based on the difference in daily TNSS (the sum of all 9 ratings) and maximum TNSS (the highest score of the 9). ResultsRhinix™ reduced daily TNSS by 21% (P=0.049), daily sneezing by 45% (P=0.01), maximum itching by 46% (P=0.004) and maximum sneezing by 38% (P=0.001) when compared to placebo. Rhinix™ failed to show a significant reduction in the primary efficacy endpoint of difference in maximum TNSS (P=0.14) with a mean reduction of 14% and median reduction of 33% when compared to placebo. The nasal filters were well tolerated and no serious adverse events were recorded. Rhinix™ reduced daily TNSS by 21% (P=0.049), daily sneezing by 45% (P=0.01), maximum itching by 46% (P=0.004) and maximum sneezing by 38% (P=0.001) when compared to placebo. Rhinix™ failed to show a significant reduction in the primary efficacy endpoint of difference in maximum TNSS (P=0.14) with a mean reduction of 14% and median reduction of 33% when compared to placebo. The nasal filters were well tolerated and no serious adverse events were recorded. ConclusionsAlthough maximum TNSS showed no statistically significant difference, statistically significant and clinically relevant reductions were achieved with Rhinix™ nasal filters in daily TNSS as well as in a subset of individual symptoms for patients with seasonal allergic rhinitis. Although maximum TNSS showed no statistically significant difference, statistically significant and clinically relevant reductions were achieved with Rhinix™ nasal filters in daily TNSS as well as in a subset of individual symptoms for patients with seasonal allergic rhinitis.