Efficacy Park Study Assessing Rhinix™ Nasal Filters for Hay Fever

Study Overview
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Brief Summary
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This study will evaluate the effects of RHINIX™ nasal filters on seasonal allergic rhinitis (hay fever) in a park setting.

Detailed Description
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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.

Official Title
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A Double-blind, Placebo-controlled, Randomized Single-centre Crossover Park Study Assessing Rhinix™ Nasal Filters

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Device: Placebo Filter
* Device: Rhinix Nasal Filter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of seasonal allergic rhinitis (SAR) for a minimum of 2 years before study entry. Documented by a positive skin test (wheal > 3mm) within 12 months of study enrolment. Written informed consent Must be able to complete the study Reliable anticonception for fertile women FEV1 higher than 70 % of predicted value Positive grass IgE blood sample higher or equal to 0,7 kU/L Exclusion Criteria: Improper fit of the Rhinix™ device Nasal septal deviation Retrospective TNSS for last summer < 3 Positive pregnancy test for fertile women Inadequate washout periods in regards to park study appointments (intranasal or systemic corticosteroids (1month), intranasal cromolyn (2 weeks), intranasal or systemic decongestants (3 days), intranasal or systemic antihistamines (3 days), Loratadine (10 days)). Rhinitis medicamentosa Use of long acting anti-histamines. Documented evidence of acute or cronic sinusitis, as determined by the individual investigator. FEV1 lower than 70 % of predicted value Subjects with nasal conditions likely to affect the outcome of the study in the opinion of the investigator, i.e. anterior nasal septum deviation, nasal septal perforations, nasal polyps, chronic nasal obstruction or other nasal diseases. Receipt of immunotherapy with grass pollen within the previous 10 years (at least two rounds of treatment). Women who are breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Filter<br>Placebo device | Device: Placebo Filter<br> <br> |
| Active Comparator: Rhinix Nasal Filter<br>Actual Rhinix Nasal Filter | Device: Rhinix Nasal Filter<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 11.00-17.00 with recordings at 30. minute increments. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 11.00-17.00 at 30 minute increments |