Efficacy Park Study Assessing Rhinix™ Nasal Filters for Hay Fever

Seasonal Allergic Rhinitis Clinical Trial

Official title:

A Double-blind, Placebo-controlled, Randomized Single-centre Crossover Park Study Assessing Rhinix™ Nasal Filters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02108574
• Other study ID #: 1401
• Status: Completed
• Phase: N/A
• First received: March 18, 2014
• Last updated: December 19, 2014
• Start date: April 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the effects of RHINIX™ nasal filters on seasonal allergic rhinitis (hay fever) in a park setting.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• History of seasonal allergic rhinitis (SAR) for a minimum of 2 years before study entry. Documented by a positive skin test (wheal > 3mm) within 12 months of study enrolment.

• Written informed consent

• Must be able to complete the study

• Reliable anticonception for fertile women

• FEV1 higher than 70 % of predicted value

• Positive grass IgE blood sample higher or equal to 0,7 kU/L

Exclusion Criteria:

• Improper fit of the Rhinix™ device

• Nasal septal deviation

• Retrospective TNSS for last summer < 3

• Positive pregnancy test for fertile women

• Inadequate washout periods in regards to park study appointments (intranasal or systemic corticosteroids (1month), intranasal cromolyn (2 weeks), intranasal or systemic decongestants (3 days), intranasal or systemic antihistamines (3 days), Loratadine (10 days)).

• Rhinitis medicamentosa

• Use of long acting anti-histamines.

• Documented evidence of acute or cronic sinusitis, as determined by the individual investigator.

• FEV1 lower than 70 % of predicted value

• Subjects with nasal conditions likely to affect the outcome of the study in the opinion of the investigator, i.e. anterior nasal septum deviation, nasal septal perforations, nasal polyps, chronic nasal obstruction or other nasal diseases.

• Receipt of immunotherapy with grass pollen within the previous 10 years (at least two rounds of treatment).

• Women who are breastfeeding

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Device:
• Placebo Filter

• Rhinix Nasal Filter

Locations

Country	Name	City	State
Denmark	Aarhus University, School of Public Health, Department of Environmental & Occupational Medicine	Aarhus C

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Rhinix ApS

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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	No
Secondary	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	No
Secondary	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	No