Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation

NCT ID: NCT00415493

Last Updated: 2017-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2008-05-31

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.

Conditions

Vasomotor Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Order 1

Cold-dry air provocation followed (on a separate day) by Warm-moist air provocation

Group Type: EXPERIMENTAL

Cold-dry air provocation

Intervention Type: OTHER

15 minute exposure to cold-dry air by nasal mask

Warm-moist air provocation

Intervention Type: OTHER

15 minute exposure to warm-moist air by nasal mask

Order 2

Warm-moist air provocation followed (on a separate day) by Cold-dry air provocation

Group Type: EXPERIMENTAL

Cold-dry air provocation

Intervention Type: OTHER

15 minute exposure to cold-dry air by nasal mask

Warm-moist air provocation

Intervention Type: OTHER

15 minute exposure to warm-moist air by nasal mask

Interventions

Cold-dry air provocation

15 minute exposure to cold-dry air by nasal mask

Intervention Type: OTHER

Warm-moist air provocation

15 minute exposure to warm-moist air by nasal mask

Intervention Type: OTHER

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.

(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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Washington

OTHER

Sponsor Role: collaborator

Associated Scientists to Help Minimize Allergies

OTHER

Sponsor Role: lead

Responsible Party

Stephen A. Tilles MD

Executive Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dennis Shusterman, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Stephen A Tilles,, MD

Role: STUDY_DIRECTOR

ASTHMA, Inc.

Locations

ASTHMA, Inc.

Seattle, Washington, United States

Countries

United States

Other Identifiers

AI-005 NAR

Identifier Type: -

Identifier Source: org_study_id