Birch Associated Soy Allergy and Immuno-Therapy
| ISRCTN | ISRCTN67316358 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67316358 |
| Secondary identifying numbers | 1-2009 |
- Submission date
- 03/08/2009
- Registration date
- 27/08/2009
- Last edited
- 08/08/2019
- 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
Prof Jan Christoph Simon
Scientific
Scientific
Ph.-Rosenthal-Str. 23
Leipzig
04103
Germany
Study information
| Study design | Prospective double blind randomised multicentre two-armed therapy trial; phase IIb |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A multicentre randomised placebo-controlled double-blind clinical trial for the evaluation of efficacy of specific immunotherapy (SIT) with an aluminium hydroxide-adsorbed recombinant hypoallergenic derivative of the major birch pollen allergen r Bet v1-FV on Bet v 1 associated soy allergy |
| Study acronym | BASALIT |
| Study objectives | To determine the efficacy of specific subcutaneous immunotherapy (SCIT) against birch allergen Bet v 1 on birch pollen associated soy allergy. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Immediate type allergy to soy proteins in patients with birch pollinosis |
| Intervention | Specific subcutaneous immunotherapy with extract containing either main Birch allergen Bet v 1 or placebo (randomisation 2:1), duration: 1 year, no follow up. |
| Intervention type | Other |
| Primary outcome measure | Threshold dose of soy protein leading to first symptoms at DBPCFC (lowest observed adverse effect level - LOAEL); two primary endpoints (without hierarchy) - LOAELobj for clinically objective and LOAELsubj for subjective symptoms. Timepoints: baseline 9 months - 1 week before intervention, control: 2 weeks - 5 months after intervention. |
| Secondary outcome measures | 1. Skin prick test to soy. Timepoint: baseline 9 months - 1 week before intervention, control: at end of intervention (week 50 - 52 of intervention). 2. Food allergy related quality of life. Timepoint: baseline 9 months - 1 week before intervention, control: at end of intervention (week 50 - 52 of intervention). 3. Specific IgE and IgG4 against Bet v 1, Gly m 4, Cor a 1, Mal d 1, Pru Av 1, Cau c 1, Api g 1. Timepoint: baseline at start of invervention, control at week 12, 18, 30, 50 - 52 of intervention. 4. T-cell reactivity to Bet v 1 and Gly m 4. Timepoint: baseline at start of intervention, control at week 18 and 50 - 52. |
| Overall study start date | 01/10/2009 |
| Completion date | 31/03/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 97 |
| Total final enrolment | 56 |
| Key inclusion criteria | 1. Male or female adult patients aged 18 - 65 years inclusive, legally competent 2. Informed consent 3. History of spring pollinosis for at least 2 years 4. Sensitisation to birch pollen as demonstrated by positive SPT to birch (wheal greater than 3 mm) 5. Specific IgE for Bet v 1 and Gly m4 (both greater than ImmunoCAP class 1 6. Clinical relevance of Gly m4 sensitization as demonstrated by positive food challenge (DBPCFC) to soy proteins 7. For female patients: effective contraception and negative pregnancy test result |
| Key exclusion criteria | 1. SIT against birch within last 5 years 2. Pregnancy, lactation period or female patients seeking to become pregnant 3. Peak expiratory flow (PEF) or forced expiratory volume in one second (FEV1) less than 80% of predicted normal (ECCS) or 4. Uncontrolled bronchial asthma according to Global Initiative for Asthma (GINA) 2006 5. Febrile infections or inflammation of the respiratory tract at the time of inclusion 6. Irreversible secondary lung alterations (i.e. emphysema, bronchiektasia) 7. Severe acute or chronic diseases, severe inflammatory diseases 8. Other severe generalised diseases (liver, heart, kidney, metabolic disorders) 9. Autoimmune diseases, immune defects including immunosuppression, immune-complex induced immunopathies 10. Severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse) 11. Completed or ongoing long-term treatment with tranquilizer or psycho-active drugs 12. Short time therapy with oral glucocorticosteroids is possible under certain circumstances 13. Concurrent participation in any other clinical trial or participation in any other clinical trial during the previous 30 days 14. Low compliance or inability to understand instructions/study documents 15. Patients who have been committed to a mental hospital by government or court 16. Completed or ongoing treatment with anti-IgE antibody 17. Patients being in any relationship or dependence with the sponsor and/or investigator 18. Contraindication for adrenaline, (e.g. acute or chronic symptomatic coronary heart disease, severe arterial hypertension) 19. Therapy with betablockers topically or systemically 20. Patient's withdrawal of consent |
| Date of first enrolment | 01/10/2009 |
| Date of final enrolment | 31/03/2013 |
Locations
Countries of recruitment
- Germany
- Switzerland
Study participating centre
Ph.-Rosenthal-Str. 23
Leipzig
04103
Germany
04103
Germany
Sponsor information
University of Leipzig (Germany)
University/education
University/education
c/o Dr Frank Nolden
Ritterstraße 26
Leipzig
04109
Germany
| Website | http://www.uni-leipzig.de/english/ |
|---|---|
"ROR" |
https://ror.org/03s7gtk40 |
Funders
Funder type
Government
German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)
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 | 01/08/2017 | 08/08/2019 | Yes | No |
Editorial Notes
08/08/2019: Publication reference and total final enrolment added.
