Efficacy and Safety of Nasal Filters on Seasonal Allergic Rhinitis (Hay Fever)

Study Overview
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Brief Summary
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The purpose of this study is to assess the effect of reducing exposure to allergens in patients with hay fever by means of a nasal filter.

Official Title
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Efficacy and Safety of Nasal Filters on Seasonal Allergic Rhinitis in a Double-blinded Randomized Placebo-controlled Crossover Pilot Study

Conditions
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Rhinitis, Allergic, Seasonal

Intervention / Treatment
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* Device: Nasal filter
* Device: Placebo nasal filter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of seasonal allergic rhinitis (SAR) for a minimum of 2 years before study entry. Documented by a positive skin test within 12 months of study enrollment. Written informed consent Reliable anticonception for fertile women Must be able to complete the study Forced Expiratory Volume at one second (FEV1) higher than 70 % of predicted value Positive grass immunoglobulin-E (IgE) blood sample equal to or higher than 3,50 kU/L Exclusion Criteria: Positive pregnancy test for fertile women Asthma unless mild and only occurring in relation to the grass pollen season as assessed by the investigator Inadequate washout periods in regards to Environmental Exposure Unit (EEU) 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 chronic sinusitis as determined by individual investigator FEV1 lower than 70 % of predicted value Subjects with perennial allergic rhinitis (PAR) to e.g. house dust mites, cats, dogs moulds unless symptom free Allergic rhinitis requiring medication caused by allergens other than grass unless symptom free 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 septum perforations, nasal polyps, chronic nasal obstruction or other nasal diseases Receipt of immunotherapy with grass pollen within the previous 10 years Women who are breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Placebo Nasal filter<br>Placebo treatment | Device: Placebo nasal filter<br>* Placebo nasal filter<br>|
| Active Comparator: Nasal Filter<br>Active treatment | Device: Nasal filter<br>* Active nasal filter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of active nasal filters compared to placebo filters in the same patient group as measured by difference in maximum Total Nasal Symptom Score | To assess the effects of active nasal filters on symptoms development in patients with seasonal allergic rhinitis (SAR) exposed to air-born allergens compared to the same patients in an exposed environment with a placebo nasal filter determined by their maximum Total Nasal Symptom Score (TNSS) out of the nine samples taken during a trial day. The statistical analysis will be done using non-parametric paired Wilcoxon signed rank test. | Day 1 and day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of active nasal filters compared to placebo filters as measured by acoustic rhinometry | To assess the effects of active nasal filters on intranasal volume in patients with seasonal allergic rhinitis (SAR) exposed to air-born allergens compared to the same patients in an exposed environment with a placebo nasal filter. The assessment will be based on the difference between minimum and maximum volume as determined by acoustic rhinometry measurements pre- and post-exposure on each study day. The statistical analysis will be a parametric paired t-test. | Day 1 and day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hay, rhinitis, allergic, seasonal, double blind, doubleblind, randomized, randomised, placebo, crossover, clinical, nasal, filter, controlled, trial, hayfever, fever, efficacy, safety, prevention, adult, grass, pollen, symptom, Total nasal symptom score, acoustic rhinometry