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

Not Applicable

Completed

• Conditions: Rhinitis, Allergic, Seasonal
• Interventions: Device: Placebo nasal filter; Device: Nasal filter

• Registration Number: NCT01699165
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-08-16
• Study First Submitted QC: 2012-10-02
• Study First Posted: 2012-10-03
• Study Start: 2012-12
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-18
• Last Update Posted: 2013-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo Nasal filter	Placebo nasal filter	Placebo treatment
Nasal Filter	Nasal filter	Active treatment

Primary Outcome Measures

Name	Time	Method
Effect of active nasal filters compared to placebo filters in the same patient group as measured by difference in maximum Total Nasal Symptom Score	Day 1 and day 15	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.

Secondary Outcome Measures

Name	Time	Method
Effect of active nasal filters compared to placebo filters as measured by acoustic rhinometry	Day 1 and day 15	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.

Trial Locations

Locations (1)

Aarhus University, School of Public Health, Department of Environmental & Occupational Medicine; 🇩🇰 Aarhus, Denmark