Condition category
Respiratory
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
25/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr D. Boot

ORCID ID

Contact details

Zernikedreef 10
Leiden
2333 CL
Netherlands
+31 (0)71 5246407
dboot@chdr.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR412; P04.230

Study information

Scientific title

Acronym

Study hypothesis

Added 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

Received from local medical ethics committee

Study design

Randomised double blind placebo controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Other

Patient information sheet

Condition

Atopic rhinitis

Intervention

Subjects underwent a nasal allergen challenge with a relevant allergen.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Primary 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 measures

To identify an appropriate study population for intervention studies with anti-allergic agents such as anti-IL13.

Overall trial start date

26/04/2005

Overall trial end date

26/08/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female subjects
2. 18-50 years of age with atopic rhinitis

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. 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

Recruitment start date

26/04/2005

Recruitment end date

26/08/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Zernikedreef 10
Leiden
2333 CL
Netherlands

Sponsor information

Organisation

Centocor Inc. (USA)

Sponsor details

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

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Centocor Inc. (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17362248

Publication citations

  1. Results

    Boot JD, de Kam ML, Mascelli MA, Miller B, van Wijk RG, de Groot H, Cohen AF, Diamant Z, Nasal nitric oxide: longitudinal reproducibility and the effects of a nasal allergen challenge in patients with allergic rhinitis., Allergy, 2007, 62, 4, 378-384, doi: 10.1111/j.1398-9995.2007.01328.x.

Additional files

Editorial Notes