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Completed

NCT Number: NCT00415493

Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ASTHMA, Inc.

Seattle, Washington, 98105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

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.

Treatment and study plan

Cold-dry air provocation

Other

15 minute exposure to cold-dry air by nasal mask

Warm-moist air provocation

Other

15 minute exposure to warm-moist air by nasal mask

Primary outcomes

  1. Net Proportional Change in Nasal Airway Resistance

    Time frame: One hour

    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.

Sponsors and collaborators

Lead sponsor

Associated Scientists to Help Minimize Allergies

Other

Collaborators

  • University of Washington

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Dec 25, 2006
Registry last updated
Mar 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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