N/A
N=24
Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation
Vasomotor Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT00415493 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcome: Primary: Net Proportional Change in Nasal Airway Resistance — 0.11; 0.04 proportional change (unit-less)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cold-dry air provocation (Other); Warm-moist air provocation (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Associated Scientists to Help Minimize Allergies
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Net Proportional Change in Nasal Airway Resistance |
0.11; 0.04 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00415493). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.