Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation

• ClinicalTrials.gov Identifier: NCT00415493
• Recruitment Status: Completed
• First Posted: December 25, 2006
• Results First Posted: October 26, 2012
• Last Update Posted: March 6, 2017
• Sponsor: Associated Scientists to Help Minimize Allergies
• Collaborator: University of Washington
• Information provided by (Responsible Party): Stephen A. Tilles MD, Associated Scientists to Help Minimize Allergies

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.

Condition or disease	Intervention/treatment	Phase
Vasomotor Rhinitis	Other: Cold-dry air provocation; Other: Warm-moist air provocation	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Investigator)
• Primary Purpose: Diagnostic
• Official Title: Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation
• Study Start Date: December 2006
• Actual Primary Completion Date: October 2007
• Actual Study Completion Date: May 2008

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• 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

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:

Clinical Research Facility 

• Responsible Party: Stephen A. Tilles MD, Executive Director, Associated Scientists to Help Minimize Allergies
• ClinicalTrials.gov Identifier: NCT00415493
• Other Study ID Numbers: AI-005 NAR
• First Posted: December 25, 2006
• Results First Posted: October 26, 2012
• Last Update Posted: March 6, 2017
• Last Verified: January 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Stephen A. Tilles MD, 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