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Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation

Primary Purpose

Vasomotor Rhinitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cold-dry air provocation
Warm-moist air provocation
Sponsored by
Associated Scientists to Help Minimize Allergies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Vasomotor Rhinitis focused on measuring rhinitis, non-allergic rhinitis, rhinomanometry, cold air, triggers: cold, dry air inhalation, warm, most air inhalation, Nonallergic rhinitis; normal controls

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • ASTHMA, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Order 1

Order 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 21, 2006
Last Updated
January 23, 2017
Sponsor
Associated Scientists to Help Minimize Allergies
Collaborators
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT00415493
Brief Title
Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation
Official Title
Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Associated Scientists to Help Minimize Allergies
Collaborators
University of Washington

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasomotor Rhinitis
Keywords
rhinitis, non-allergic rhinitis, rhinomanometry, cold air, triggers: cold, dry air inhalation, warm, most air inhalation, Nonallergic rhinitis; normal controls

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Order 1
Arm Type
Experimental
Arm Description
Cold-dry air provocation followed (on a separate day) by Warm-moist air provocation
Arm Title
Order 2
Arm Type
Experimental
Arm Description
Warm-moist air provocation followed (on a separate day) by Cold-dry air provocation
Intervention Type
Other
Intervention Name(s)
Cold-dry air provocation
Intervention Description
15 minute exposure to cold-dry air by nasal mask
Intervention Type
Other
Intervention Name(s)
Warm-moist air provocation
Intervention Description
15 minute exposure to warm-moist air by nasal mask
Primary Outcome Measure Information:
Title
Net Proportional Change in Nasal Airway Resistance
Description
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.
Time Frame
One hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Shusterman, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen A Tilles,, MD
Organizational Affiliation
ASTHMA, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
ASTHMA, Inc.
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.asthmainc.org
Description
Clinical Research Facility

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Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation

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