An interventional study of Placebo Filter and Rhinix Nasal Filter in Seasonal Allergic Rhinitis, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-12-23.
Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment
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.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 69 is below the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placebo device
Device: Placebo Filter
Actual Rhinix Nasal Filter
Device: Rhinix Nasal Filter
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
Time frame: 11.00-17.00 with recordings at 30. minute increments.
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.
Time frame: 11.00-17.00 with hourly increments
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.
Time frame: 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.
Time frame: 11.00-17.00 at 30 minute increments
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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University of Aarhus