No registrations found.
Source
Brief title
Sponsors and support
Centocor Inc
200 Great Valley Parkway
19355-1307 Malvern
Pennsylvania USA
Tel: 00 1 610 2408475
Intervention
No registrations found.
Outcome measures
Primary outcome
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 outcome
To identify an appropriate study population for intervention studies with anti-allergic agents such as anti-IL13.
Background summary
To investigate the role of mediators and cytokines in the pathophysiology of asthma and atopy, potent (specific) antagonists are the preferential tools. In this pilot study, we intend to validate potential outcome parameters and assays for a future study with anti-IL13 compounds. To this end, we intend to validate the reproducibility of skin prick tests (SPT), IgE, and several surrogate markers of allergic inflammation.
Study objective
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.
Study design
N/A
Intervention
Subjects underwent a nasal allergen challenge with a relevant allergen according.
D. Boot
Zernikedreef 10
Leiden 2333 CL
The Netherlands
+31 (0)71 5246407
dboot@chdr.nl
D. Boot
Zernikedreef 10
Leiden 2333 CL
The Netherlands
+31 (0)71 5246407
dboot@chdr.nl
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;
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL372 |
NTR-old | NTR412 |
Other | : P04.230 |
ISRCTN | ISRCTN34415480 |