E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
IgE-mediated allergic diseases including allergic rhinitis/rhinoconjunctivitis, allergic bronchial asthma (GINA I and II) triggered by birch pollen allergens |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of the trial is last patient last visit |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 1 |