Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation

Study Overview
=================
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 Description
-----------------
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.

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

Conditions
-----------------
Vasomotor Rhinitis

Intervention / Treatment
-----------------
* Other: Cold-dry air provocation
* Other: Warm-moist air provocation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (cases; n = 14 total; 10 with predominantly physical and 4 with predominantly irritanttriggers): A significant history of chronic and/or recurrent nasal symptoms (rhinorrhea, blockage,sneezing or pruritus) in response to: Changes in temperature and/or humidity predominantly (physical triggers; n = 10); or Two or more nonspecific irritant triggers predominantly, including: perfumes or colognes,cleaning products, environmental tobacco smoke, vehicular exhaust, paint odors, etc. (irritant triggers;n = 4). This history shall be of at least two years' duration. Exclusion Criteria: (controls; n = 10): A significant history of chronic and/or recurrent nasal symptoms (rhinorrhea, blockage,sneezing or pruritus) in response to one or more nonallergic triggers, including: perfumes or colognes, cleaning products, environmental tobacco smoke, vehicular exhaust, paint odors, changes in temperature and/or humidity. Exclusion criteria: (all subjects; n = 24): A prior history of allergic disease (allergic rhinitis, asthma, angioedema, anaphylaxis) Significant skin test reactivity to one or more substances in a panel of 24 locally relevant seasonal and perennial aeroallergens Negative wheal response to positive control (histamine) on skin test panel Abnormalities on a screening x-ray (Waters view) of the paranasal sinuses Cigarette smoking (active, within previous 6 months or cumulative history of >20 pack years) Chronic cardiopulmonary diseases (asthma, COPD, coronary artery disease…) Continuous therapy with medications having antihistaminic or autonomic primary or secondary effects (e.g., oral or topical antihistamines, tricyclic antidepressants, ipratropium bromide, albuterol, alpha- or beta-adrenergic blockers...) Unable to provide meaningful tracings on screening rhinomanometry. Pregnancy (or planned pregnancy within 6 months); positive urinary HCG at screening visit. Patient is a breast feeding female. Upper respiratory infection (common cold or sinusitis) within 2 week of screening. Patient has participated in a clinical trial involving an investigational drug within 4 weeks of visit 1.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Order 1<br>Cold-dry air provocation followed (on a separate day) by Warm-moist air provocation | Other: Cold-dry air provocation<br>* 15 minute exposure to cold-dry air by nasal mask<br>Other: Warm-moist air provocation<br>* 15 minute exposure to warm-moist air by nasal mask<br>|
| Experimental: Order 2<br>Warm-moist air provocation followed (on a separate day) by Cold-dry air provocation | Other: Cold-dry air provocation<br>* 15 minute exposure to cold-dry air by nasal mask<br>Other: Warm-moist air provocation<br>* 15 minute exposure to warm-moist air by nasal mask<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Net Proportional Change in Nasal Airway Resistance | 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. | One hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rhinitis, non-allergic rhinitis, rhinomanometry, cold air, triggers: cold, dry air inhalation, warm, most air inhalation, Nonallergic rhinitis; normal controls