A Double-blind, Placebo-controlled, Randomized Single-centre Crossover Park Study Assessing Rhinix™ Nasal Filters
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 69
- Locations
- 1
- Primary Endpoint
- To assess the change in daily Total Nasal Symptom Score (TNSS) between Rhinix™ and placebo
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Placebo Filter
Placebo device
Intervention: Placebo Filter (Device)
Rhinix Nasal Filter
Actual Rhinix Nasal Filter
Intervention: Rhinix Nasal Filter (Device)
Outcomes
Primary Outcomes
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 Outcomes
- Change in Daily TNSS for subgroup(11.00-17.00 at 30 minute increments)
- To assess the correlation between maximum TNSS and difference in Daily TNSS(11.00-17.00 at 30 minute increments)
- To assess the change in Daily Throat Irritation between Rhinix™ and placebo(11.00-17.00 with hourly increments)