Overview

This trial is active, not recruiting.

Condition seasonal allergic rhinitis
Treatments placebo filter, rhinix nasal filter
Sponsor University of Aarhus
Collaborator Rhinix ApS
Start date April 2014
End date December 2015
Trial size 100 participants
Trial identifier NCT02108574, 1401

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Placebo device
placebo filter
(Active Comparator)
Actual Rhinix Nasal Filter
rhinix nasal filter

Primary Outcomes

Measure
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.

Secondary Outcomes

Measure
To assess the change in Daily Throat Irritation between Rhinix™ and placebo
time frame: 11.00-17.00 with hourly increments
To assess the correlation between maximum TNSS and difference in Daily TNSS
time frame: 11.00-17.00 at 30 minute increments
Change in Daily TNSS for subgroup
time frame: 11.00-17.00 at 30 minute increments

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title A Double-blind, Placebo-controlled, Randomized Single-centre Crossover Park Study Assessing Rhinix™ Nasal Filters
Principal investigator Torben Sigsgaard, Professor
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University of Aarhus.