Allergy to apple in birch pollen allergic patients
Conditions
Interventions
Product Name: r Mal d 1
Product Code: Mal d 1
Pharmaceutical Form: Oromucosal drops
INN or Proposed INN: r Mal d 1
Current Sponsor code: rMal d 1.0108-GMP-0902
Other descriptive name: rMal d 1
Concent
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Austria
Contacts
Public ContactBarbara Bohle
Medical University of Vienna
Outcome results
None listed