IgE-mediated allergic diseases including allergic rhinitis/rhinoconjunctivitis, allergic bronchial asthma (GINA I and II) triggered by birch pollen allergens
Conditions
Interventions
Product Name: aluminium hydroxide-adsorbed allergoid preparation of birch pollen allergens
Product Code: AL0204AV
Pharmaceutical Form: Suspension for injection
Pharmaceutical form of the placebo: Susp
Sponsors
Allergopharma Joachim Ganzer KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with IgE-mediated, moderate to severe seasonal allergic rhinitis/rhinoconjunctivitis with or without bronchial asthma (GINA grade I and II), attributable to birch pollen allergens Symptoms of allergic rhinitis/rhinoconjunctivitis against birch pollen allergens requiring medication during birch pollen season 2005 Positive EAST/CAP to birch pollen class = 2 Positive prick test reaction to natural birch pollen allergens Proven clinical relevance of birch pollen allergy by positive conjunctival provocation test result using natural birch pollen extract 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) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Previous course of hyposensitation against tree pollens or other allergens that are not known Patients that have undergone an unsuccessful course of specific immunotherapy with any allergen Symptoms during birch pollen season related to or strong skin test positivity (weal diameter = diameter of the birch pollen weal) to alder, hazel, poplar, elm, willow-tree, beech, oak, ash, rape, Dermatophagoides pteronyssinus, Dermatophagoides farinae, dog, cat, Aspergillus, Penicillium Clinically relevant rhinitis/rhinoconjunctival or respiratory symptoms related to other reasons that have not been clearly identified FEV1 < 80 % of predicted normal (ECCS) Moderate to severe bronchial asthma (GINA grade III and IV) Vasomotor, drug-induced or other kinds of non allergic rhinitis/rhinoconjunctivitis Febrile infections or inflammation of the respiratory tract at the time of inclusion Irreversible secondary alterations of the reactive organ (emphysema, bronchiectasis etc.) Allergy treatment according to severity of symptoms with other than the following medication during the birch pollen season: Levocabastine nasal spray/eye drops (0,5 mg/ml each), Loratadine/Cetirizine tablets (10 mg), Salbutamol (100 µg/puff). Exacerbation treatment with a short course of oral corticosteroids. Unchanged basic treatment with inhaled corticosteroids up to 400 µg Budesonide or equivalent is permitted. Treatment with other medication must be stopped 2 weeks prior to birch pollen season. Any prophylactic and any treatment with antiallergic medication in fixed (constant) dosage during the birch pollen season
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the trial is to show safety and efficacy of the allergoid preparation of birch pollen allergens in the treatment of birch allergic patients in a representative number of patients and according to the latest regulatory requirements. ;Secondary Objective: Symptom-Medication-Score after 1 year of treatment Symptom-Medication-Score after 3 years of treatment for patients of the verum group Rhinoconjunctivitis quality of life (RQLQ) Changes in specific conjunctival provocation test Immunologic changes: Allergen specific IgE, IgG1 and IgG4. Tolerability and safety will be assessed during the initial treatment phase and after each injection by evaluating the documentation of adverse events and other parameters. ;Primary end point(s): The primary endpoint of this study is the area under the curve (AUC) of the Symptom-and-Medication Score (SMS) after 2 years of double-blind treatment. For this purpose patients will carefully complete a diary over a time period of anticipated 8 weeks during two birch pollen seasons in 2006 and 2007. A symptom medication score (SMS) will be calculated by the daily sum of allergic symptoms and the daily sum of intake of additional antiallergic medication. | — |
Countries
Finland, Germany, Sweden
Outcome results
None listed