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View Clinical Trial (Medical Research Study)
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Nasal Physiologic Reactivity of Nonallergic Rhinitis to Cold Air Provocation - NCT00415493-98105 (Clinical Trial 159445)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy159445.aspx
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| City: |
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Seattle |
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State:
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WA |
| Zip Code: |
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98105 |
| Conditions: |
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Vasomotor Rhinitis |
| Purpose: |
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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, ten VMR patients with symptoms triggered
predominantly by chemicals, and ten nonallergic, non-rhinitic control subjects will be
studied.
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| Study summary: |
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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. |
| Criteria: |
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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. |
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| Study is available at: |
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ASTHMA, Inc.
Seattle, WA 98105
United States
Primary Contact:
Stephen A Tilles, MD
Email: stilles@nwasthma.com
Phone: 206.525.5520 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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