None listed
Conditions
Interventions
Subjects underwent a nasal allergen challenge with a relevant allergen according.
Sponsors
C. Cusumano
Centocor Inc
200 Great Valley Parkway
19355-1307 Malvern
Pennsylvania USA
Tel: 00 1 610 2408475
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects; 2. 18-50 years of age with atopic rhinitis.
Exclusion criteria
Exclusion criteria: 1. Current 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; 3. Not able to stop maintenance therapy. The following medicactions should be stopped before and during the study: a. topical or systemic anti-inflammatory therapy with anti-IgE (>6 months); b. corticosteroids inhaled or nasal sprays (>6 weeks); c. oral corticosteroids >8 weeks; d. LTRAs >4 weeks; e. cromones >2 wk; f. anticholinergics >1 wk; g. long-acting oral antihistamines >7 days; h. short-acting oral antihistamines > 2 days; i. theophylline >3 days. j. No other nasal sprays (other than ICS) cromoglycate >2 wk; k. nasal antihistamines >2 days; l. xylomethazolin and NaCl 0.9% >1 day; 4. Use of topical corticosteroid containing cr¨¨mes on maintenance basis on the site of investigation (volar side of underarms, or elbows); 5. History of serious food or medication allergy or anaphylaxis; 6. History of alcohol or drug abuse; 7. Desensibilization therapy in the past; 8. Vaccinations in the past 1 month; 9. Viral respiratory tract infections within 3 weeks; 10. Nasal polyps; 11. Nasal surgery in the past 3 months; 12. Not able to collaborate in the study; 13. Treatment with any investigational drug for at least 3 months prior to this study or ¡Ý3 clinical trial participations in the last year; 14. Positive serology to hepatitis B or C or human immunodeficiency virus (HIV); 15. Blood donation of more than 500 ml during the previous 3 months (men) or 4 months (women), according to Sanquin guidelines.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study objectives: 1. To test the reproducibility, in atopic subjects with a clinically stable allergic rhinitis, of: a. SPT; b. Relevant markers of allergic rhinitis and atopy in peripheral blood; 2. To validate the following assays for measuring relevant biomarkers in atopic subjects with a clinically stable allergic rhinitis: a. Exhaled nasal air; b. Peripheral blood; c. Nasal lavage; d. Nasal brush. | — |
Secondary
| Measure | Time frame |
|---|---|
| To identify an appropriate study population for intervention studies with anti-allergic agents such as anti-IL13. | — |
Contacts
Public ContactD. Boot
Center for Human Drug Research (CHDR), Zernikedreef 10
Outcome results
None listed