Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation

This study has been completed.
Sponsor:
Collaborator:
University of Washington
Information provided by (Responsible Party):
Stephen A. Tilles MD, Associated Scientists to Help Minimize Allergies
ClinicalTrials.gov Identifier:
NCT00415493
First received: December 21, 2006
Last updated: September 26, 2012
Last verified: September 2012
  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, four VMR patients with symptoms triggered predominantly by chemicals, and ten nonallergic, non-rhinitic control subjects will be studied.


Condition Intervention
Vasomotor Rhinitis
Other: Cold-dry air provocation
Other: Warm-moist air provocation

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

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

Primary Outcome Measures:
  • Net Proportional Change in Nasal Airway Resistance [ Time Frame: One hour ] [ Designated as safety issue: No ]
    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.


Enrollment: 24
Study Start Date: December 2006
Study Completion Date: May 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Order 1
Cold-dry air provocation followed (on a separate day) by Warm-moist air provocation
Other: Cold-dry air provocation
15 minute exposure to cold-dry air by nasal mask
Other: Warm-moist air provocation
15 minute exposure to warm-moist air by nasal mask
Experimental: Order 2
Warm-moist air provocation followed (on a separate day) by Cold-dry air provocation
Other: Cold-dry air provocation
15 minute exposure to cold-dry air by nasal mask
Other: Warm-moist air provocation
15 minute exposure to warm-moist air by nasal mask

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 = 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00415493

Locations
United States, Washington
ASTHMA, Inc.
Seattle, Washington, United States, 98105
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:
No publications provided

Responsible Party: Stephen A. Tilles MD, Executive Director, Associated Scientists to Help Minimize Allergies
ClinicalTrials.gov Identifier: NCT00415493     History of Changes
Other Study ID Numbers: AI-005 NAR
Study First Received: December 21, 2006
Results First Received: July 20, 2012
Last Updated: September 26, 2012
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 July 24, 2014