ew treatment for apple allergy in birch pollen allergic patients

Phase 1

• Conditions: Allergy to apple in birch pollen allergic patients; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2011-001221-24-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-15
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

All patients must have suffered from birch pollen-induced allergic rhinitis
and apple-induced birch pollen-associated oral food allergy for at least the last 2 years, positive skin prick tests (SPT) to birch pollen and specific IgE levels to birch pollen, rBet v 1 and rMal d 1 >0.70 kU/L at screening. Moreover, patients must have positive prick-to-prick (PtP) tests with apple and respond positive in double blind placebo controlled food challenges (DBPFCF) with GMP-rMal d 1
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria will be: malignancies, autoimmune and
cardiopulmonary diseases, anemia, hyper-IgE syndrome, intake of betablockers, a history of life-threatening asthma or daily requirement of asthma treatment. Patients who had previously developed severe
symptoms to apples will as well as patients being treated with inhaled
steroids within 4 weeks prior to screening visit cannot be included. None of the patients should currently undergo SIT to any allergen source or have undergone birch pollen SIT during the past 5 years. Pregnant and lactating women will also be excluded

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Treatment of apple allergy in birch pollen allergic patients;Secondary Objective: To investigate the pathomechanism of immune modulation and tolerance induction;Primary end point(s): Reactivity in skin prick tests, intradermal tests and oral provocation tests;Timepoint(s) of evaluation of this end point: After the treatment of 16 weeks of sublingual therapy (in comparison to the tests performed before treatment)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Antibody and T cell responses to Mal d1 and Bet v 1;Timepoint(s) of evaluation of this end point: before, during and after the treatment peroid of 16 weeks