Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Net Proportional Change in Nasal Airway Resistance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(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.
排除标准
- •(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.
结局指标
主要结局
Net Proportional Change in Nasal Airway Resistance
时间窗: 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.
次要结局
未报告次要终点
研究者
Stephen A. Tilles MD
Executive Director
Associated Scientists to Help Minimize Allergies