Efficacy Park Study Assessing Rhinix™ Nasal Filters for Hay Fever
|ClinicalTrials.gov Identifier: NCT02108574|
Recruitment Status : Completed
First Posted : April 9, 2014
Last Update Posted : December 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Seasonal Allergic Rhinitis||Device: Placebo Filter Device: Rhinix Nasal Filter||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-blind, Placebo-controlled, Randomized Single-centre Crossover Park Study Assessing Rhinix™ Nasal Filters|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Placebo Comparator: Placebo Filter
|Device: Placebo Filter|
Active Comparator: Rhinix Nasal Filter
Actual Rhinix Nasal Filter
|Device: Rhinix Nasal Filter|
- To assess the change in daily Total Nasal Symptom Score (TNSS) between Rhinix™ and placebo [ Time Frame: 11.00-17.00 with recordings at 30. minute increments. ]
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
- To assess the change in Daily Throat Irritation between Rhinix™ and placebo [ Time Frame: 11.00-17.00 with hourly increments ]
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.
- To assess the correlation between maximum TNSS and difference in Daily TNSS [ Time Frame: 11.00-17.00 at 30 minute increments ]
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.
- Change in Daily TNSS for subgroup [ Time Frame: 11.00-17.00 at 30 minute increments ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02108574
|Aarhus University, School of Public Health, Department of Environmental & Occupational Medicine|
|Aarhus C, Denmark, 8000|
|Principal Investigator:||Torben Sigsgaard, Professor||Aarhus University, School of Public Health, Dept. of Environmental & Occupational Medicine|