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| Name | Class |
|---|---|
| Rhinix ApS | UNKNOWN |
| Astma-Allergi Danmark | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rhinix Nasal Filters | Experimental | All included will receive rhinix nasal filters |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rhinix Nasal Filters | Device |
|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Week 1: Correlation of use and allergy severiy | 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. | One assessment at the end of the 1st week of use |
| Week 2: Correlation between use and allergy severity |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Torben Sigsgaard, Prof MD | Aarhus University, School of Public Health, Dept. of Environmental & Occupational Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University, School of Public Health, Department of Environmental & Occupational Medicine | Aarhus | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26897304 | Derived | Kenney P, Hilberg O, Sigsgaard T. Clinical Application of Nasal Filters: An Observational Study on the Usability of Nasal Filters in Managing Seasonal Allergic Rhinitis. J Allergy Clin Immunol Pract. 2016 May-Jun;4(3):445-452.e4. doi: 10.1016/j.jaip.2016.01.003. Epub 2016 Feb 18. |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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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. |
Week 2: To assess the correlation between symptom severity at screening and likelihood of answering that they will definitely/likely continue using the product. |
| One assessment at the end of the 2nd week of use |
| Week 1: Perceived decrease in medication | In week 1: To assess whether use of RHINIX has led to a perceived decrease in use of medication. | One assessment after the 1st week of use |
| Week 2: Perceived decrease in medication | Week 2: To assess whether use of RHINIX has led to a perceived decrease in use of medication. | One assessment after 2nd week of use |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |