Nasal Physiologic Reactivity of Nonallergic Rhinitis to Cold Air Provocation

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2006 by Associated Scientists to Help Minimize Allergies. Recruitment status was Recruiting

First Received on December 21, 2006. Last Updated on January 5, 2007 History of Changes

Sponsor:	Associated Scientists to Help Minimize Allergies
Collaborator:	University of Washington
Information provided by:	Associated Scientists to Help Minimize Allergies
ClinicalTrials.gov Identifier:	NCT00415493

Purpose

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, ten VMR patients with symptoms triggered predominantly by chemicals, and ten nonallergic, non-rhinitic control subjects will be studied.

Condition	Intervention
Vasomotor Rhinitis	Procedure: cold air

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind Primary Purpose: Diagnostic
Official Title:	Nasal Physiologic Reactivity of Nonallergic Rhinitis to Cold Air Provocation

Further study details as provided by Associated Scientists to Help Minimize Allergies:

Primary Outcome Measures:

symptom rating + nasal airway resistance

Estimated Enrollment:	30
Study Start Date:	December 2006
Estimated Study Completion Date:	June 2008

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

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

(cases; n = 20 total; 10 each with predominantly “physical” and 10 “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 = 10). 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 = 30):

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.
Patient is a current or recent past (within the past 10 years) abuser of alcohol or is currently a user or recent past (within 10 years) abuser of illicit drugs.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00415493

Contacts

Contact: Stephen A Tilles, MD	206.525.5520	stilles@nwasthma.com
Contact: Dennis Shusterman, MD, MPH	(206) 744-9398	dennis3@u.washington.edu

Locations

United States, Washington
ASTHMA, Inc.	Recruiting
Seattle, Washington, United States, 98105
Sub-Investigator: Stephen A Tilles,, MD

Sponsors and Collaborators

Associated Scientists to Help Minimize Allergies

University of Washington

Investigators

Principal Investigator:	Dennis Shusterman, MD, MPH	University of Washington
Study Director:	Stephen A Tilles,, MD	ASTHMA, Inc.

More Information

Additional Information:

Clinical Research Facility This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00415493 History of Changes
Other Study ID Numbers:	AI-005 NAR
Study First Received:	December 21, 2006
Last Updated:	January 5, 2007
Health Authority:	United States: Institutional Review Board

Keywords provided by Associated Scientists to Help Minimize Allergies:

rhinitis
non-allergic rhinitis
rhinomanometry
cold air

triggers: cold, dry air inhalation
warm, most air inhalation
Nonallergic rhinitis; normal controls

Additional relevant MeSH terms:

Rhinitis
Rhinitis, Vasomotor
Nose Diseases

Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on February 09, 2012