Clinical trial NCT00415493: Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation
Official title: Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vasomotor Rhinitis
Keywords: rhinitis
non-allergic rhinitis
rhinomanometry
cold air
triggers: cold, dry air inhalation
warm, most air inhalation
Nonallergic rhinitis; normal controls
Lead sponsor: Associated Scientists to Help Minimize Allergies
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2006-12-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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:

  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.

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.

Primary outcomes:
measure: Net Proportional Change in Nasal Airway Resistance
timeFrame: One hour
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: ASTHMA, Inc.
state: Washington
Study officials:
affiliation: University of Washington
name: Dennis Shusterman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: ASTHMA, Inc.
name: Stephen A Tilles,, MD
role: STUDY_DIRECTOR
References: