Birch Associated Soy Allergy and Immuno-Therapy

Phase 2

Completed

• Conditions: Respiratory; Immediate type allergy to soy proteins in patients with birch pollinosis; Vasomotor and allergic rhinitis

• Registration Number: ISRCTN67316358
• Lead Sponsor: niversity of Leipzig (Germany)

Brief Summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/27998002 (added 08/08/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-27
• Study Completion: 2013-03-31
• Last Update Posted: 2 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 56

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified