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

niversity of Leipzig (Germany)0 sites56 target enrollmentAugust 27, 2009

Overview

Registry

who.int

Start Date

August 27, 2009

End Date

March 31, 2013

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Leipzig (Germany)

•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

•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)