Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation
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ClinicalTrials.gov Identifier: NCT00415493 |
Recruitment Status :
Completed
First Posted : December 25, 2006
Results First Posted : October 26, 2012
Last Update Posted : March 6, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Vasomotor Rhinitis | Other: Cold-dry air provocation Other: Warm-moist air provocation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Diagnostic |
Official Title: | Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation |
Study Start Date : | December 2006 |
Actual Primary Completion Date : | October 2007 |
Actual Study Completion Date : | May 2008 |
Arm | Intervention/treatment |
---|---|
Experimental: Order 1
Cold-dry air provocation followed (on a separate day) by Warm-moist air provocation
|
Other: Cold-dry air provocation
15 minute exposure to cold-dry air by nasal mask Other: Warm-moist air provocation 15 minute exposure to warm-moist air by nasal mask |
Experimental: Order 2
Warm-moist air provocation followed (on a separate day) by Cold-dry air provocation
|
Other: Cold-dry air provocation
15 minute exposure to cold-dry air by nasal mask Other: Warm-moist air provocation 15 minute exposure to warm-moist air by nasal mask |
- Net Proportional Change in Nasal Airway Resistance [ Time Frame: One hour ]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.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
(cases; n = 14 total; 10 with predominantly "physical" and 4 with predominantly "irritant"triggers):
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00415493
United States, Washington | |
ASTHMA, Inc. | |
Seattle, Washington, United States, 98105 |
Principal Investigator: | Dennis Shusterman, MD, MPH | University of Washington | |
Study Director: | Stephen A Tilles,, MD | ASTHMA, Inc. |
Responsible Party: | Stephen A. Tilles MD, Executive Director, Associated Scientists to Help Minimize Allergies |
ClinicalTrials.gov Identifier: | NCT00415493 |
Other Study ID Numbers: |
AI-005 NAR |
First Posted: | December 25, 2006 Key Record Dates |
Results First Posted: | October 26, 2012 |
Last Update Posted: | March 6, 2017 |
Last Verified: | January 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
rhinitis non-allergic rhinitis rhinomanometry cold air |
triggers: cold, dry air inhalation warm, most air inhalation Nonallergic rhinitis; normal controls |
Rhinitis Rhinitis, Vasomotor Nose Diseases |
Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases |