Nasal Physiologic Reactivity of Nonallergic Rhinitis to Cold Air Provocation

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.

Inclusion Criteria:

(cases; n = 20 total; 10 each with predominantly “physical” and 10 “irritant”triggers):

- A significant history of chronic and/or recurrent nasal symptoms (rhinorrhea,
blockage,sneezing or pruritus) in response to:

1. Changes in temperature and/or humidity predominantly (“physical triggers”; n =
10); or

2. Two or more nonspecific irritant triggers predominantly, including: perfumes or
colognes,cleaning products, environmental tobacco smoke, vehicular exhaust,
paint odors, etc. (“irritant triggers”;n = 10). 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 = 30):

- 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.

- Patient is a current or recent past (within the past 10 years) abuser of alcohol or
is currently a user or recent past (within 10 years) abuser of illicit drugs.