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
Scientific
Zernikedreef 10
Leiden
2333 CL
Netherlands
| Phone | +31 (0)71 5246407 |
|---|---|
| dboot@chdr.nl |
Study information
| 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 |
| Scientific title | |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 26/08/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | 1. Male or female subjects 2. 18-50 years of age with atopic rhinitis |
| Key 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 |
| Date of first enrolment | 26/04/2005 |
| Date of final enrolment | 26/08/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Zernikedreef 10
Leiden
2333 CL
Netherlands
2333 CL
Netherlands
Sponsor information
Centocor Inc. (USA)
Industry
Industry
200 Great Valley Parkway
Pennsylvania
Malvern
19355-1307
United States of America
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
