Patients have to suffer from IgE mediated allergic rhinits, rhinoconjunctivitis +/- asthma due to sensitization again birch pollen. MedDRA version: 7.0 Level: LLT Classification code 10036019
Conditions
Interventions
Product Name: Depigoid Birch
Product Code: Allergen extract
Pharmaceutical Form: Injection*
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Subcutaneous use
Sponsors
LETI Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients of both gender at an age from 6 up to 45 years - Prior to study specific examinations, the patient has to give his/her written informed consent. If patients under legal age will be included, the informed consent must be signed by at least one of the parents or the legal responsible guardian. - The patients have to suffer from seasonal complaints (rhinitis and/or rhinoconjunctivitis with or without allergic asthma) caused by clinical sensitisation against birch pollen. The sensitisation against birch pollen has to be verified by - suggestive medical history - a positive skin prick test for birch pollen, resulting in a wheal diameter of at least 4 mm > negative control reaction or '++' versus histamine - specific IgE for birch pollen >= 2 - Patient’s perception of disease activity of at least 30 mm on a 100 mm visual analogue scale (VAS) Are the trial subjects under 18? yes 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - pregnant or lactating women - women of child-bearing age not employing sufficient contraceptive protection - clinical relevant manifestation - defined as positive suggestive history within the last 12 months checked by a comprehensive questionnaire of symptoms, confirmed by a positive skin prick test (wheal diameter of at least 4 mm > negative control reac-tion or '++' versus histamine) as well as by specific IgE (Rast I or higher) - of the following allergies: - a perennial allergy against house dust mites (Dermatophagoides pteronyssinus or D. farinae), animal epithelia (of cats or dogs) or mould - a seasonal allergy against grasses (included rye) or weeds - participation in an immunotherapy with comparable extracts within the last five years - participation in another clinical trial within the last 3 month prior to this study - any contra-indication for the unspecific bronchial challenge test - smokers with a manifested bronchopathy - alcohol- or drug abusers - persons, who are obviously not compliant - patients with other known concomitant diseases: - acute tuberculosis - inflammatory or infectious diseases of the target organs effective - advanced secondary changes at the target organ (e.g. emphysema or bronchiectasis) - immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role - immune deficiencies - history of status asthmaticus, heart- and vascular insufficiency, treatment with beta-blockers - any disease which prohibits the use of adrenaline (e. g. hyperthyroidism) - serious psychiatric / psychological disturbances - concomitant treatment with substances interfering with the immune system
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: For the primary criterion, the area under the curve for the symptom load over the time of exposition will be compared. During the pollen flight time, the active treated group should have a lower symptom load in comparison to the placebo group.;Secondary Objective: Secondary parameter considered in this trial will be the following: - symptom score - medication score - specific antibody concentrations (IgG1, IgG4, IgE) - pollencount for the different time intervals - adverse events - oral allergy syndrome - quality of life;Primary end point(s): The main parameter in this study is the symptom load during the predefined pollen season. It is defined as the time weighted area under the curve of the daily symptom load including all days of the pollen season. The daily symptom load is the sum of the daily rescue medication score and the daily symptom severity score. At the initial and all subsequent examinations, patients will be questioned about their allergic symptoms and the intensity. The same questions are listed in the patient diary. Before the pollen season, the patients will document their symptoms every two weeks, during the pollen season daily. Symptom severity: Every day / every second week the severity of the day’s/week’s sneezing, itchy nose, runny nose, stuffy nose, itchy eyes, watery eyes and red eyes are evaluated (on a per-symptom basis) using a following 4-point scale. Symptom duration Every day/week the duration of the day’s itchy nose, runny nose, stuffy nose, itchy eyes, watery eyes, and red eyes are evaluated (on a per symptom basis) using a 4-point scale. The weekly/daily symptom severity score of a patient is the mean of all single scores, i.e. the weekly/daily score is ranging from 0 to 3. Any rescue medication which is known to have an influence on the typical allergic symptoms is taken into account for the calculation of the weekly/daily rescue medication score. The medication is recorded in the patient’s diary. The followi | — |
Countries
Sweden
Outcome results
None listed