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| Name | Class |
|---|---|
| University of Washington | OTHER |
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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, four VMR patients with symptoms triggered predominantly by chemicals, and ten nonallergic, non-rhinitic control subjects will be studied.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Order 1 | Experimental | Cold-dry air provocation followed (on a separate day) by Warm-moist air provocation |
|
| Order 2 | Experimental | Warm-moist air provocation followed (on a separate day) by Cold-dry air provocation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cold-dry air provocation | Other | 15 minute exposure to cold-dry air by nasal mask |
|
| Measure | Description | Time Frame |
|---|---|---|
| Net Proportional Change in Nasal Airway Resistance | 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 |
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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:
Exclusion Criteria:
(controls; n = 10):
Exclusion criteria:
(all subjects; n = 24):
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Shusterman, MD, MPH | University of Washington | Principal Investigator |
| Stephen A Tilles,, MD | ASTHMA, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASTHMA, Inc. | Seattle | Washington | 98105 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cold-dry Air Followed by Warm-moist Air | To control for possible stimulus-order effects, half of the subjects were evaluated pre- and post-exposure to Cold-dry air followed (on a separate day) by Warm-moist air. Exposures lasted 15 minutes, with a one-hour follow-up period. |
| FG001 | Warm-moist Air Followed by Cold-dry Air | To control for possible stimulus-order effects, half of the subjects were evaluated pre- and post-exposure to Warm-moist air followed (on a separate day) by Cold-dry air. Exposures lasted 15 minutes, with a one-hour follow-up period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cases | non-allergic rhinitis subjects |
| BG001 | Controls | normal subjects |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Net Proportional Change in Nasal Airway Resistance | 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. | Posted | Mean | Standard Error | proportional change (unit-less) | One hour |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cases | non-allergic rhinitis subjects |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | ASTHMA Inc. | (510) 620-5714 | dennis.shusterman@cdph.ca.gov |
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| ID | Term |
|---|---|
| D012223 | Rhinitis, Vasomotor |
| D012220 | Rhinitis |
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012141 | Respiratory Tract Infections |
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| Warm-moist air provocation | Other | 15 minute exposure to warm-moist air by nasal mask |
|
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| Cases |
non-allergic rhinitis subjects |
| OG001 | Controls | normal subjects |
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Controls | normal subjects | 0 | 10 | 0 | 10 |
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| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |