This study will evaluate the effects of RHINIX™ nasal filters on seasonal allergic rhinitis (hay fever) in a park setting.
The study will include 100 participants with grass allergy and will look at the efficacy and usability of RHINIX™ nasal filters on hay fever in a randomized, double-blind, placebo-controlled, crossover design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
69
Aarhus University, School of Public Health, Department of Environmental & Occupational Medicine
Aarhus C, Denmark
To assess the change in daily Total Nasal Symptom Score (TNSS) between Rhinix™ and placebo
Baseline recording at 09.00 Run-in recordings from 09.30-11.00 Daily Total Nasal Symptom Score evaluated from 11.00-17.00 with the last recording at 17.00, recordings at 30 minute increments. Total Nasal Symptom Score is the sum of 4 symptoms (runny nose, blocked nose, itchy nose and sneezing) which are each evaluated on a scale of 0=none, 1=mild, 2=moderate, 3=severe symptoms
Time frame: 11.00-17.00 with recordings at 30. minute increments.
To assess the change in Daily Throat Irritation between Rhinix™ and placebo
Baseline recording at 09.00 Run-in recording at. 10.00 Daily Throat Irritation evaluated from 11.00-17.00 with the last recording at 17.00, recordings at hourly increments. Daily Throat Irritation is the sum of 6 symptom ratings on a Visual Analogue Scale.
Time frame: 11.00-17.00 with hourly increments
To assess the correlation between maximum TNSS and difference in Daily TNSS
Daily TNSS is described in the Primary Efficacy Endpoint. Maximum TNSS is the single highest TNSS between 11.00 and 17.00 The correlation will be graphically shown using a Bland-Altman plot.
Time frame: 11.00-17.00 at 30 minute increments
Change in Daily TNSS for subgroup
Subgroup analysis of change in daily TNSS between RHINIX and placebo for the subjects with at least one rating of TNSS ≥ 6 on at least one of the two study days. See primary outcome measure for more details.
Time frame: 11.00-17.00 at 30 minute increments
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