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Efficacy Park Study Assessing Rhinix™ Nasal Filters for Hay Fever

This study has been completed.
Rhinix ApS
Information provided by (Responsible Party):
University of Aarhus Identifier:
First received: March 18, 2014
Last updated: December 19, 2014
Last verified: December 2014
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
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, 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. ]

    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 ]

    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 ]

    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 ]

    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.

Enrollment: 69
Study Start Date: April 2014
Study Completion Date: December 2014
Primary Completion Date: December 2014 (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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT02108574

Aarhus University, School of Public Health, Department of Environmental & Occupational Medicine
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Rhinix ApS
Principal Investigator: Torben Sigsgaard, Professor Aarhus University, School of Public Health, Dept. of Environmental & Occupational Medicine
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Aarhus Identifier: NCT02108574     History of Changes
Other Study ID Numbers: 1401
Study First Received: March 18, 2014
Last Updated: December 19, 2014

Additional relevant MeSH terms:
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases processed this record on April 27, 2017