Efficacy Park Study Assessing Rhinix™ Nasal Filters for Hay Fever
Seasonal Allergic Rhinitis
Device: Placebo Filter
Device: Rhinix Nasal Filter
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Double-blind, Placebo-controlled, Randomized Single-centre Crossover Park Study Assessing Rhinix™ Nasal Filters|
- 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. ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.
|Study Start Date:||April 2014|
|Study Completion Date:||December 2014|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo Filter
|Device: Placebo Filter|
Active Comparator: Rhinix Nasal Filter
Actual Rhinix Nasal Filter
|Device: Rhinix Nasal Filter|
Please refer to this study by its ClinicalTrials.gov identifier: 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|