Contact information
Type
Scientific
Contact name
Dr D. Boot
ORCID ID
Contact details
Zernikedreef 10
Leiden
2333 CL
Netherlands
+31 (0)71 5246407
dboot@chdr.nl
Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
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
Study setting(s)
Not specified
Study type
Other
Patient information sheet
Condition
Atopic rhinitis
Intervention
Subjects underwent a nasal allergen challenge with a relevant allergen.
Intervention type
Other
Primary outcome measure
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 study start date
26/04/2005
Overall study end date
26/08/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male or female subjects
2. 18-50 years of age with atopic rhinitis
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Upper age limit
50 Years
Sex
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
Study 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
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2007 | Yes | No |