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Efficacy Park Study Assessing Rhinix™ Nasal Filters for Hay Fever

Primary Purpose

Seasonal Allergic Rhinitis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Placebo Filter
Rhinix Nasal Filter
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo Filter

Rhinix Nasal Filter

Arm Description

Placebo device

Actual Rhinix Nasal Filter

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
March 18, 2014
Last Updated
December 19, 2014
Sponsor
University of Aarhus
Collaborators
Rhinix ApS
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1. Study Identification

Unique Protocol Identification Number
NCT02108574
Brief Title
Efficacy Park Study Assessing Rhinix™ Nasal Filters for Hay Fever
Official Title
A Double-blind, Placebo-controlled, Randomized Single-centre Crossover Park Study Assessing Rhinix™ Nasal Filters
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Rhinix ApS

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Filter
Arm Type
Placebo Comparator
Arm Description
Placebo device
Arm Title
Rhinix Nasal Filter
Arm Type
Active Comparator
Arm Description
Actual Rhinix Nasal Filter
Intervention Type
Device
Intervention Name(s)
Placebo Filter
Intervention Type
Device
Intervention Name(s)
Rhinix Nasal Filter
Primary Outcome Measure Information:
Title
To assess the change in daily Total Nasal Symptom Score (TNSS) between Rhinix™ and placebo
Description
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.
Secondary Outcome Measure Information:
Title
To assess the change in Daily Throat Irritation between Rhinix™ and placebo
Description
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
Title
To assess the correlation between maximum TNSS and difference in Daily TNSS
Description
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
Title
Change in Daily TNSS for subgroup
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torben Sigsgaard, Professor
Organizational Affiliation
Aarhus University, School of Public Health, Dept. of Environmental & Occupational Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University, School of Public Health, Department of Environmental & Occupational Medicine
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
26141263
Citation
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.
Results Reference
derived

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Efficacy Park Study Assessing Rhinix™ Nasal Filters for Hay Fever

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