Seasonal Allergic Rhinitis
Conditions
Brief summary
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.
Interventions
DEVICERhinix Nasal Filters
Sponsors
Rhinix ApS
Astma-Allergi Danmark
University of Aarhus
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Week 1 likelihood of continued use of RHINIX after study end. | 1 assessment at the end of the 1st week of use. | 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. |
| Week 2 likelihood of continued use of RHINIX after study end. | 1 assessment at the end of the 2nd week of use. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Week 2 satisfaction with RHINIX | One assessment at the end of the 2nd week | In week 2: The proportion of subjects who are completely or somewhat satisfied with RHINIX given that they have used the product. |
| Week 1 Satisfaction with RHINIX | 1 assessment at the end of the 1st week | In week 1: The proportion of subjects who are completely or somewhat satisfied with RHINIX given that they have used the product. |
| Week 1: RHINIX Control | One assessment at the end of the 1st week of use | 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 |
| Week 2: RHINIX Control | One assessment at the end of the 2nd week of use. | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Week 1: Perceived decrease in medication | One assessment after the 1st week of use | In week 1: To assess whether use of RHINIX has led to a perceived decrease in use of medication. |
| Week 2: Perceived decrease in medication | One assessment after 2nd week of use | Week 2: To assess whether use of RHINIX has led to a perceived decrease in use of medication. |
| Week 2: Correlation between use and allergy severity | One assessment at the end of the 2nd week of use | Week 2: To assess the correlation between symptom severity at screening and likelihood of answering that they will definitely/likely continue using the product. |
| Week 1: Correlation of use and allergy severiy | One assessment at the end of the 1st week of use | In week 1: To assess the correlation between symptom severity at screening and likelihood of answering that they will definitely/likely continue using the product. |
Countries
Denmark
Outcome results
None listed