Clinical trial NCT02108574: 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
Overall status: COMPLETED
Phase: NA
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Rhinix ApS
First posted: 2014-04-09
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To assess the change in daily Total Nasal Symptom Score (TNSS) between Rhinix™ and placebo
timeFrame: 11.00-17.00 with recordings at 30. minute increments.
Secondary outcomes:
measure: To assess the change in Daily Throat Irritation between Rhinix™ and placebo
timeFrame: 11.00-17.00 with hourly increments
measure: To assess the correlation between maximum TNSS and difference in Daily TNSS
timeFrame: 11.00-17.00 at 30 minute increments
measure: Change in Daily TNSS for subgroup
timeFrame: 11.00-17.00 at 30 minute increments
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Aarhus University, School of Public Health, Department of Environmental & Occupational Medicine
Study officials:
affiliation: Aarhus University, School of Public Health, Dept. of Environmental & Occupational Medicine
name: Torben Sigsgaard, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.