The effect of birch pollen immunotherapy on hazelnut allergy.
| ISRCTN | ISRCTN52709516 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52709516 |
| Protocol serial number | NTR172 |
| Sponsor | University Medical Centre Utrecht (UMCU) (The Netherlands) |
| Funder | ALK-Abello BV (The Netherlands) |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 18/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr K.A.B.M. Peeters
Scientific
Scientific
University Medical Centre Utrecht
Department of Dermatology/Allergology
P.O. Box 85500
Utrecht
3508 GA
Netherlands
| Phone | +31 (0)30 250 7388 |
|---|---|
| K.A.B.M.Peeters@umcutrecht.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double-blind, placebo controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | The effect of birch pollen immunotherapy on hazelnut allergy evaluated by DBPCFC with hazelnut |
| Study objectives | The severity of hazelnut allergy will decrease as an additional effect by birch pollen immunotherapy. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Pollen/hazelnut allergy |
| Intervention | Immunotherapy with birch pollen extract. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Birch pollen extract |
| Primary outcome measure(s) |
DBPCFC with hazelnut before immunotherapy with birch pollen and after 1 year. |
| Key secondary outcome measure(s) |
1. Skin prick tests |
| Completion date | 01/11/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 19 |
| Key inclusion criteria | Patients greater than 18 years with birch pollen allergy and hazelnut allergy |
| Key exclusion criteria | 1. Pregnancy 2. Significant concurrent disease 3. Instable asthma and oral medication with corticosteroids or beta-blocking agents |
| Date of first enrolment | 01/04/2004 |
| Date of final enrolment | 01/11/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Utrecht
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
