Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT00415493
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:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00415493
Study Brief:
Protocol Section:
NCT00415493