Condition category
Respiratory
Date applied
03/08/2009
Date assigned
27/08/2009
Last edited
27/08/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jan Christoph Simon

ORCID ID

Contact details

Ph.-Rosenthal-Str. 23
Leipzig
04103
Germany

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 measures

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

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

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

http://www.uni-leipzig.de/english/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes