Status:
COMPLETED
Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation
Lead Sponsor:
Associated Scientists to Help Minimize Allergies
Collaborating Sponsors:
University of Washington
Conditions:
Vasomotor Rhinitis
Eligibility:
All Genders
18-60 years
Phase:
NA
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 a...
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 ...
Eligibility Criteria
Inclusion
- (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:
- 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
- (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.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00415493
Start Date
December 1 2006
End Date
May 1 2008
Last Update
March 6 2017
Active Locations (1)
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1
ASTHMA, Inc.
Seattle, Washington, United States, 98105