Validation study to explore potential outcome parameters for a study with anti-IL-13 in allergic syndrome/asthma.
Completed
- Registration Number
- NL-OMON26418
- Lead Sponsor
- C. CusumanoCentocor Inc200 Great Valley Parkway19355-1307 MalvernPennsylvania USATel: 00 1 610 2408475
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
1. Male or female subjects;
2. 18-50 years of age with atopic rhinitis.
Exclusion Criteria
1. Current smokers (<6 months stopped) or ex-smokers (>10 packyears);
2. Any clinically significant deviation from normal in either the general physical examination or laboratory parameters as evaluated by the investigator at Occasion 1;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary study objectives:<br /><br>1. To test the reproducibility, in atopic subjects with a clinically stable allergic rhinitis, of: <br /><br>a. SPT; <br /><br>b. Relevant markers of allergic rhinitis and atopy in peripheral blood;<br /><br><br /><br /><br>2. To validate the following assays for measuring relevant biomarkers in atopic subjects with a clinically stable allergic rhinitis:<br /><br>a. Exhaled nasal air;<br /><br>b. Peripheral blood;<br /><br>c. Nasal lavage;<br /><br>d. Nasal brush.<br />
- Secondary Outcome Measures
Name Time Method To identify an appropriate study population for intervention studies with anti-allergic agents such as anti-IL13.