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| Name | Class |
|---|---|
| Rhinix ApS | UNKNOWN |
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This study will evaluate the effects of RHINIX™ nasal filters on seasonal allergic rhinitis (hay fever) in a park setting.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Filter | Placebo Comparator | Placebo device |
|
| Rhinix Nasal Filter | Active Comparator | Actual Rhinix Nasal Filter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Filter | Device |
| ||
| Rhinix Nasal Filter |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Torben Sigsgaard, Professor | 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 C | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26141263 | Derived | Kenney P, Hilberg O, Laursen AC, Peel RG, Sigsgaard T. Preventive effect of nasal filters on allergic rhinitis: A randomized, double-blind, placebo-controlled crossover park study. J Allergy Clin Immunol. 2015 Dec;136(6):1566-1572.e5. doi: 10.1016/j.jaci.2015.05.015. Epub 2015 Jun 30. |
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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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|
| 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 |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |