Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation

Vasomotor Rhinitis Clinical Trial

Official title:

Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00415493
• Other study ID #: AI-005 NAR
• Status: Completed
• Phase: N/A
• First received: December 21, 2006
• Last updated: September 26, 2012
• Start date: December 2006
• Est. completion date: May 2008

Study information

• Verified date: September 2012
• Source: Associated Scientists to Help Minimize Allergies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Vasomotor
• Vasomotor Rhinitis

Intervention

Other:
• Cold-dry air provocation
15 minute exposure to cold-dry air by nasal mask
• Warm-moist air provocation
15 minute exposure to warm-moist air by nasal mask

Locations

Country	Name	City	State
United States	ASTHMA, Inc.	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Associated Scientists to Help Minimize Allergies	University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

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