Vasomotor Rhinitis
Conditions
Keywords
rhinitis, non-allergic rhinitis, rhinomanometry, cold air, triggers: cold, dry air inhalation, warm, most air inhalation, Nonallergic rhinitis; normal controls
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 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.
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.
Interventions
OTHERCold-dry air provocation
15 minute exposure to cold-dry air by nasal mask
OTHERWarm-moist air provocation
15 minute exposure to warm-moist air by nasal mask
Sponsors
University of Washington
Associated Scientists to Help Minimize Allergies
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
(cases; n = 14 total; 10 with predominantly physical and 4 with predominantly irritanttriggers): * 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 = 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Net Proportional Change in Nasal Airway Resistance | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cases non-allergic rhinitis subjects | 14 |
| Controls normal subjects | 10 |
| Total | 24 |
Baseline characteristics
| Characteristic | Controls | Cases | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 14 Participants | 24 Participants |
| Age, Continuous | 32.7 years STANDARD_DEVIATION 14.6 | 36.9 years STANDARD_DEVIATION 10.5 | 35.1 years STANDARD_DEVIATION 12.2 |
| Region of Enrollment United States | 10 participants | 14 participants | 24 participants |
| Sex: Female, Male Female | 7 Participants | 10 Participants | 17 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 10 |
| serious Total, serious adverse events | 0 / 14 | 0 / 10 |
Outcome results
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.
Time frame: One hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cases | Net Proportional Change in Nasal Airway Resistance | 0.11 proportional change (unit-less) | Standard Error 0.27 |
| Controls | Net Proportional Change in Nasal Airway Resistance | 0.04 proportional change (unit-less) | Standard Error 0.16 |