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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: University of Aarhus

Current Primary Outcome: Effect of active nasal filters compared to placebo filters in the same patient group as measured by difference in maximum Total Nasal Symptom Score [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Effect of active nasal filters compared to placebo filters as measured by acoustic rhinometry [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: University of Aarhus

Dates:
Date Received: August 16, 2012
Date Started: December 2012
Date Completion:
Last Updated: April 18, 2013
Last Verified: April 2013