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Validation study to explore potential outcome parameters for a study with anti-IL-13 in allergic syndrome/asthma.


- candidate number1615
- NTR NumberNTR412
- ISRCTNISRCTN34415480
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR13-sep-2005
- Secondary IDsP04.230 
- Public TitleValidation study to explore potential outcome parameters for a study with anti-IL-13 in allergic syndrome/asthma.
- Scientific TitleValidation study to explore potential outcome parameters for a study with anti-IL-13 in allergic syndrome/asthma.
- ACRONYMN/A
- hypothesisPrimary 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.
- Healt Condition(s) or Problem(s) studiedAtopic rhinitis
- Inclusion criteria1. Male or female subjects;
2. 18-50 years of age with atopic rhinitis.
- Exclusion criteria1. 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 °›3 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 26-apr-2005
- planned closingdate26-aug-2005
- Target number of participants20
- InterventionsSubjects underwent a nasal allergen challenge with a relevant allergen according.
- Primary outcomePrimary 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 outcomeTo identify an appropriate study population for intervention studies with anti-allergic agents such as anti-IL13.
- TimepointsN/A
- Trial web sitehttp://www.chdr.nl
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES D. Boot
- CONTACT for SCIENTIFIC QUERIES Z. Diamant
- Sponsor/Initiator Centocor Inc.
- Funding
(Source(s) of Monetary or Material Support)
Centocor BV Leiden
- PublicationsN/A
- Brief summaryTo 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.
- Main changes (audit trail)
- RECORD13-sep-2005 - 5-sep-2008


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