Clinical Trial: Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation

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

Official Title: Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation

Brief Summary: This study seeks to compare patients with vasomotor rhinitis ("perennial nonallergic rhinitis," "idiopathic rhinitis") with normal controls with respect to their nasal physiologic reactivity to cold air challenge. Ten vasomotor rhinitis (VMR) patients with nasal symptoms triggered predominantly by cold air, four VMR patients with symptoms triggered predominantly by chemicals, and ten nonallergic, non-rhinitic control subjects will be studied.

Detailed Summary: After initial screening and verification that subjects can cooperate with active posterior rhinomanometry, subjects will be scheduled for two 15-minute exposure sessions with either: cold-dry air, or warm-moist air. Subjects will rate symptoms (and have their nasal airway resistance measured in triplicate) prior to exposure and at 15-min. intervals post-exposure until an hour has passed.
Sponsor: Associated Scientists to Help Minimize Allergies

Current Primary Outcome: Net Proportional Change in Nasal Airway Resistance [ Time Frame: One hour ]

Net proportional change in nasal airway resistance, pre- to post-exposure, cold air minus warm air day, calculated as a time-weighted average over the 1.0 h post-exposure. At each time point (pre-exposure, immediately post-exposure, and at 15-, 30-, 45- and 60 minutes post-exposure), nasal airway resistance (in Pa/L/sec) was measured in triplicate. The average of each of these measures was taken for each time point. The time-weighted average of these averages was then calculated for the post-exposure time points and compared with the baseline average for that individual on that testing day. The proportional change from baseline on that day was then calculated (unit-less measure). The difference between the pre-to-post change on the cold air day minus the pre-to-post change on the warm air day was then calculated (unit-less measure). The net proportional change corrects for both inter- and intra-individual variability, which in the case of nasal airway resistance is considerable.


Original Primary Outcome: symptom rating + nasal airway resistance

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Associated Scientists to Help Minimize Allergies

Dates:
Date Received: December 21, 2006
Date Started: December 2006
Date Completion:
Last Updated: January 23, 2017
Last Verified: January 2017