IgE mediated allergic disorders triggered by birch pollen MedDRA version: 9.1 Level: LLT Classification code 10001709 Term: Allergic conjunctivitis MedDRA version: 9.1 Level: LLT Classification code 10001723 Term: Allergic rhinitis MedDRA version: 9.1 Level: LLT Classification code 10053713 Term: Allergenic desensitisation procedure MedDRA version: 9.1 Level: LLT Classification code 10053741 Term: Allergenic desensitization procedure
Conditions
Interventions
Product Name: SUBLIVAC® Birch
Pharmaceutical Form: Oromucosal drops
Trade Name: Staloral
Product Name: Staloral Birch
Pharmaceutical Form: Sublingual spray
Trade Name: Staloral
Product Name: Stalor
Sponsors
HAL Allergy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects with allergic rhinoconjunctivitis with or without mild asthma (FEV1 = 70%) due to birch pollen for at least 2 years. • Use of anti-allergy symptomatic medication in the last birch pollen season (in case of a season with low pollen counts, in one of the two previous years). • No seasonal allergic complaints induced by birch, grasses or mugwort pollen for at least 4 weeks in the absence of rescue medication during at least the last 2 weeks before the baseline. • A positive SPT (diameter =3 mm) for birch pollen and a positive specific serum anti birch IgE-test (>1 U/ml). • A positive TNPT with a birch allergen extract containing a concentration of 10, 100 or 1000 AU/ml at the baseline visit. • Age 18 years and older. • Subjects shall give a written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • A positive SPT (diameter = 3mm) for hazel or alder and the maintenance dose will not be reached before 8 October 2009. • A positive SPT (diameter = 3mm) for pets and symptoms related to concomitant sensitization to pets while having these animals at home. • A positive SPT (diameter = 3mm) for house dust mite or moulds and clinically relevant symptoms related to concomitant sensitization to house dust mite or moulds, based on the investigator's research (TNPT for example). • Allergy to any of the excipients of SUBLIVAC Birch or Staloral Birch. • Chronic asthma or emphysema, particularly with an FEV1 < 70 % of predicted value or use of inhalation corticosteroids outside grass and tree pollen season for more than two episodes and/or longer than fourteen days. • Specific findings for nose and mouth at screening or rhinoscopy before TNPT. • Serious immuno-pathological diseases or malignancies (including auto-immune diseases, tuberculosis, HIV). • Inflammation or infection of the target organ (nose, eyes and lungs). • Severe atopic dermatitis requiring systemic immuno-suppressive medication. • Allergen specific immunotherapy treatment for a period longer than three months within the last 5 years. • History of life threatening anaphylactic events, including anaphylactic food allergy, insect venom anaphylaxis, exercise or drug induced anaphylaxis. • A positive pregnancy test, lactation or inadequate contraceptive measures. (adequate measures: oral contraceptives, IUD, condom use and having no sexual relationship with a man) • Alcohol- or drug abuse. • Lack of co-operation or severe psychological disorders. • Completed or ongoing long-term treatment with tranquilizer or psycho active drugs. • Low compliance or inability to understand instructions/study documents • Completed or ongoing treatment with anti-IgE-antibody • Patients being in any relationship or dependence with the sponsor or investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to show that treatment with SUBLIVAC Birch and Staloral Birch are equally effective by means of reduction in allergy symptoms assessed by TNPT in subjects suffering from IgE mediated allergy complaints triggered by birch pollen.;Secondary Objective: A secondary objective of the study is to measure the effect of treatment by information derived from the changes in allergen specific immunoglobulins (IgE and IgG). Furthermore this study will generate data with regard to safety of the product from reported adverse events during the study, blood samples and ECG data at the baseline and at the end of study visit. ;Primary end point(s): Difference in change of the titrated nasal provocation test between the two treatment groups. | — |
Countries
Germany
Outcome results
None listed