Efficacy Park Study Assessing Rhinix™ Nasal Filters for Hay Fever

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Aarhus
Sponsor:
Collaborator:
Rhinix ApS
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT02108574
First received: March 18, 2014
Last updated: May 12, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Seasonal Allergic Rhinitis
Device: Placebo Filter
Device: Rhinix Nasal Filter

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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.



Estimated Enrollment: 100
Study Start Date: April 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Filter
Placebo device
Device: Placebo Filter
Active Comparator: Rhinix Nasal Filter
Actual Rhinix Nasal 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02108574

Contacts
Contact: Torben Sigsgaard, Prof. MD. PhD +4587168013 ts@mil.au.dk
Contact: Peter S. Kenney, MD-PhD Student ptkh@mil.au.dk

Locations
Denmark
Aarhus University, School of Public Health, Department of Environmental & Occupational Medicine Recruiting
Aarhus C, Denmark, 8000
Contact: Peter S Kenney       ptkh@mil.au.dk   
Principal Investigator: Torben Sigsgaard, Prof. MD         
Sponsors and Collaborators
University of Aarhus
Rhinix ApS
Investigators
Principal Investigator: Torben Sigsgaard, Professor Aarhus University, School of Public Health, Dept. of Environmental & Occupational Medicine
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02108574     History of Changes
Other Study ID Numbers: 1401
Study First Received: March 18, 2014
Last Updated: May 12, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on August 28, 2014