Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1-2009
Study information
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
Acronym
BASALIT
Study hypothesis
To determine the efficacy of specific subcutaneous immunotherapy (SCIT) against birch allergen Bet v 1 on birch pollen associated soy allergy.
Ethics approval
Not provided at time of registration
Study design
Prospective double blind randomised multicentre two-armed therapy trial; phase IIb
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Phase II/III
Drug names
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 trial start date
01/10/2009
Overall trial end date
31/03/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
97
Total final enrolment
56
Participant 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
Recruitment start date
01/10/2009
Recruitment end date
31/03/2013
Locations
Countries of recruitment
Germany, Switzerland
Trial participating centre
Ph.-Rosenthal-Str. 23
Leipzig
04103
Germany
Sponsor information
Organisation
University of Leipzig (Germany)
Sponsor details
c/o Dr Frank Nolden
Ritterstraße 26
Leipzig
04109
Germany
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/27998002 (added 08/08/2019)