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

ISRCTN ISRCTN34415480
DOI https://doi.org/10.1186/ISRCTN34415480
Secondary identifying numbers NTR412; P04.230
Submission date
27/01/2006
Registration date
27/01/2006
Last edited
25/08/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr D. Boot
Scientific

Zernikedreef 10
Leiden
2333 CL
Netherlands

Phone +31 (0)71 5246407
Email dboot@chdr.nl

Study information

Study designRandomised double blind placebo controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeOther
Scientific title
Study objectivesAdded 25/08/09:
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.
Ethics approval(s)Received from local medical ethics committee
Health condition(s) or problem(s) studiedAtopic rhinitis
InterventionSubjects underwent a nasal allergen challenge with a relevant allergen.
Intervention typeOther
Primary outcome measurePrimary study objectives:
1. To test the reproducibility, in atopic subjects with a clinically stable allergic rhinitis of:
1.1. SPT
1.2. 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:
2.1. Exhaled nasal air
2.2. Peripheral blood
2.3. Nasal lavage
2.4. Nasal brush
Secondary outcome measuresTo identify an appropriate study population for intervention studies with anti-allergic agents such as anti-IL13.
Overall study start date26/04/2005
Completion date26/08/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit50 Years
SexBoth
Target number of participants20
Key inclusion criteria1. Male or female subjects
2. 18-50 years of age with atopic rhinitis
Key exclusion criteria1. Current smokers (<6 months stopped) or ex-smokers (>10 pack years)
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 medications should be stopped before and during the study:
3.1. topical or systemic anti-inflammatory therapy with anti-IgE (>6 months)
3.2. corticosteroids inhaled or nasal sprays (>6 weeks)
3.3. oral corticosteroids >8 weeks
3.4. LTRAs >4 weeks; cromones >2 weeks; anticholinergics >1 week
3.5. long-acting oral antihistamines >7 days
3.6. short-acting oral antihistamines > 2 days; theophylline >3 days
3.7. No other nasal sprays (other than ICS) cromoglycate >2 weeks
3.8. nasal antihistamines >2 days
3.9. xylomethazolin and NaCl 0.9% >1 day
4. Use of topical corticosteroid containing creams 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. Desensibilisation 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
Date of first enrolment26/04/2005
Date of final enrolment26/08/2005

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Zernikedreef 10
Leiden
2333 CL
Netherlands

Sponsor information

Centocor Inc. (USA)
Industry

200 Great Valley Parkway
Pennsylvania
Malvern
19355-1307
United States of America

ROR logo "ROR" https://ror.org/05af73403

Funders

Funder type

Industry

Centocor Inc. (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2007 Yes No