Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation

NCT00415493 | Completed Results

• 1 other identifier: AI-005 NAR
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Vasomotor Rhinitis

Keywords

rhinitis; non-allergic rhinitis; rhinomanometry; cold air; triggers: cold, dry air inhalation; warm, most air inhalation; Nonallergic rhinitis; normal controls

Outcome Measures

Primary Outcomes (1)

• 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.

  One hour

Study Arms (2)

Order 1

EXPERIMENTAL

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

Other: Cold-dry air provocation; Other: Warm-moist air provocation

Order 2

EXPERIMENTAL

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

Other: Cold-dry air provocation; Other: Warm-moist air provocation

Interventions

Cold-dry air provocation OTHER

15 minute exposure to cold-dry air by nasal mask

Order 1; Order 2

Warm-moist air provocation OTHER

15 minute exposure to warm-moist air by nasal mask

Order 1; Order 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Associated Scientists to Help Minimize Allergies: lead
• University of Washington: collaborator

Study Sites (1)

ASTHMA, Inc.

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Rhinitis, Vasomotor; Rhinitis; Common Cold

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases

Results Point of Contact

• Title: Principal Investigator
• Organization: ASTHMA Inc.

dennis.shusterman@cdph.ca.gov

(510) 620-5714

Study Officials

• Dennis Shusterman, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

• Stephen A Tilles,, MD

  ASTHMA, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director

Study Record Dates

• First Submitted: December 21, 2006
• First Posted: December 25, 2006
• Study Start: December 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: May 1, 2008
• Last Updated: March 6, 2017
• Results First Posted: October 26, 2012

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)