Hypersensitivity, Immediate Clinical Trial
Official title:
Cellular Inflammation Characterization of Nasal Challenges With Fine and Ultrafine Particles
The goal of this study is to see how the type and size of particles found in air pollution affects inflammation in the nose in people who are skin test positive to at least one allergen. It has been observed that pollution makes allergies worse. It has also been suggested that very small particles may affect allergies more than larger particles.
Status | Completed |
Enrollment | 25 |
Est. completion date | January 2012 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Previously determined high inflammatory responders to Diesel Exhaust Particles - Previously determined atopy as demonstrated by allergy skin testing - Asymptomatic on day of challenge. Exclusion Criteria: - History of lung problems (including asthma), bleeding, neuromuscular, liver, kidney or heart disorders. - History of anaphylaxis. - Recent upper respiratory infection (less than 4 weeks prior to study) or other active infection. - Active smoker or smoker in the past 2 years. - Treatment with topical nasal steroids (< 1 month), systemic steroids (<1 month), oral antihistamines (< 1 week) prior to any nasal challenge. - Use of leukotriene receptor antagonist (< 1 month ) prior to any nasal challenge - Intranasal antihistamine or cromolyn use < 1 week prior to any nasal challenge . - History of treatment with allergy immunotherapy. - Inability to perform nasal lavage. - Inability to give written informed consent - Pregnancy |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)
Country | Name | City | State |
---|---|---|---|
United States | University of California, Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles | National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The number of inflammatory cells in nasal lavage samples after exposure to 4 different types of particles | 6 and 24 hours after nasal challenge | No | |
Secondary | Differential cell count in nasal lavages | 6 and 24 hours post challenge | No | |
Secondary | IL-8 in nasal lavages | 6 and 24 hours post challenge | No | |
Secondary | TNFa in nasal lavages | 6 and 24 hours post challenge | No | |
Secondary | RANTES in nasal lavages | 6 and 24 hours post challenge | No | |
Secondary | MCP-1 in nasal lavages | 6 and 24 hours post challenge | No | |
Secondary | MIP-1a in nasal lavages | 6 and 24 hours post challenge | No | |
Secondary | GM-CSF in nasal lavages | 6 and 24 hours post challenge | No | |
Secondary | Nitrite in nasal lavages | 6 and 24 hours post challenge | No | |
Secondary | Induced ROS generation (presence of intracellular thiol, 8-Isoprostane, and hydrogen peroxide) in nasal lavage cells | 6 and 24 hours post challenge | No | |
Secondary | Phase II enzymes (HO-1, GSTP1, NQO1 and GSTM1) in nasal lavage | 6 and 24 hours post challenge | No |
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