Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation

Associated Scientists to Help Minimize Allergies

Status: Completed

Conditions: Vasomotor Rhinitis

Treatments: Other: Cold-dry air provocation; Other: Warm-moist air provocation

Study type: Interventional

Funder types: Other

Identifiers

NCT00415493

AI-005 NAR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

(cases; n = 14 total; 10 with predominantly "physical" and 4 with predominantly "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 = 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Order 1

Experimental group

Description:

Cold-dry air provocation followed (on a separate day) by Warm-moist air provocation

Treatment:

Other: Warm-moist air provocation

Other: Cold-dry air provocation

Order 2

Experimental group

Description:

Warm-moist air provocation followed (on a separate day) by Cold-dry air provocation

Treatment:

Other: Warm-moist air provocation

Other: Cold-dry air provocation