Efficacy Park Study Assessing Rhinix™ Nasal Filters for Hay Fever

Not Applicable

Completed

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

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo Filter	Placebo Filter	Placebo device
Rhinix Nasal Filter	Rhinix Nasal Filter	Actual Rhinix Nasal Filter

Primary Outcome Measures

Name	Time	Method
To assess the change in daily Total Nasal Symptom Score (TNSS) between Rhinix™ and placebo	11.00-17.00 with recordings at 30. minute increments.	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

Secondary Outcome Measures

Name	Time	Method
To assess the change in Daily Throat Irritation between Rhinix™ and placebo	11.00-17.00 with hourly increments	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.
Change in Daily TNSS for subgroup	11.00-17.00 at 30 minute increments	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.
To assess the correlation between maximum TNSS and difference in Daily TNSS	11.00-17.00 at 30 minute increments	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.

Locations (1): Aarhus University, School of Public Health, Department of Environmental & Occupational Medicine
🇩🇰
Aarhus C, Denmark

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