Immediate type allergy to soy proteins in patients with birch pollinosis Respiratory Vasomotor and allergic rhinitis
Conditions
Interventions
Specific subcutaneous immunotherapy with extract containing either main Birch allergen Bet v 1 or placebo (randomisation 2:1), duration: 1 year, no follow up.
Sponsors
University of Leipzig (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany, Switzerland
Outcome results
None listed