Efficacy Park Study Assessing Rhinix™ Nasal Filters for Hay Fever

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

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

Study Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Device: Placebo Filter; Device: Rhinix Nasal Filter

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus C, Denmark, 8000
    • Aarhus University, School of Public Health, Department of Environmental & Occupational Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Filter; Placebo device	Device: Placebo Filter
Active Comparator: Rhinix Nasal Filter; Actual Rhinix Nasal Filter	Device: Rhinix Nasal Filter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Rhinix ApS
• Investigators: Principal Investigator: Torben Sigsgaard, Professor, Aarhus University, School of Public Health, Dept. of Environmental & Occupational Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: March 18, 2014
• First Submitted That Met QC Criteria: April 4, 2014
• First Posted (Estimate): April 9, 2014

Study Record Updates

• Last Update Posted (Estimate): December 23, 2014
• Last Update Submitted That Met QC Criteria: December 19, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: 1401