- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00415493
Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation
January 23, 2017 updated by: Stephen A. Tilles MD, Associated Scientists to Help Minimize Allergies
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98105
- ASTHMA, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Order 1
Cold-dry air provocation followed (on a separate day) by Warm-moist air provocation
|
15 minute exposure to cold-dry air by nasal mask
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
|
15 minute exposure to cold-dry air by nasal mask
15 minute exposure to warm-moist air by nasal mask
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
One hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Dennis Shusterman, MD, MPH, University of Washington
- Study Director: Stephen A Tilles,, MD, ASTHMA, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (Actual)
October 1, 2007
Study Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
December 21, 2006
First Submitted That Met QC Criteria
December 22, 2006
First Posted (Estimate)
December 25, 2006
Study Record Updates
Last Update Posted (Actual)
March 6, 2017
Last Update Submitted That Met QC Criteria
January 23, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AI-005 NAR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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