Compliance and Usability Study Evaluating RHINIX™ Nasal Filters

Study Overview
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Brief Summary
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This study will investigate usability and compliance related to rhinix nasal filters for the treatment of seasonal allergic rhinitis (hay fever) during the natural grass pollen season in Denmark.

Official Title
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An Open-label Outpatient In-season Study Assessing Compliance and Usability of Rhinix™ Nasal Filters

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Device: Rhinix Nasal Filters


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Motivated to try a different treatment approach to seasonal allergic rhinitis (documented by answering the call-out by Astma-Allergi Danmark) Indicates having seasonal allergic rhinitis to grass via online questionnaire Informed consent (by email acceptance after having received information on the trial) Assess to internet and email Exclusion Criteria: Improper fit of the Rhinix™ device

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rhinix Nasal Filters<br>All included will receive rhinix nasal filters | Device: Rhinix Nasal Filters<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Week 1 likelihood of continued use of RHINIX after study end. | In week 1: The proportion of subjects that rate that they will definitely or are likely to continue using RHINIX after the study is over given that they have stated that they have tried the device. | 1 assessment at the end of the 1st week of use. | 
| Week 2 likelihood of continued use of RHINIX after study end. | In week 2: The proportion of subjects that rate that they will definitely or are likely to continue using RHINIX after the study is over given that they have stated that they have tried the device. | 1 assessment at the end of the 2nd week of use. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Week 1 Satisfaction with RHINIX | In week 1: The proportion of subjects who are completely or somewhat satisfied with RHINIX given that they have used the product. | 1 assessment at the end of the 1st week | 
| Week 2 satisfaction with RHINIX | In week 2: The proportion of subjects who are completely or somewhat satisfied with RHINIX given that they have used the product. | One assessment at the end of the 2nd week | 
| Week 1: RHINIX Control | In week 1: The proportion of subjects who state that RHINIX has helped to a very high degree or to a high degree in controlling their hay fever symptoms given that they have used the product | One assessment at the end of the 1st week of use | 
| Week 2: RHINIX Control | In week 2: The proportion of subjects who state that RHINIX has helped to a very high degree or to a high degree in controlling their hay fever symptoms given that they have used the product | One assessment at the end of the 2nd week of use. |