E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
IgE mediated allergic disorders triggered by birch pollen |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001709 |
E.1.2 | Term | Allergic conjunctivitis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001723 |
E.1.2 | Term | Allergic rhinitis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10053713 |
E.1.2 | Term | Allergenic desensitisation procedure |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10053741 |
E.1.2 | Term | Allergenic desensitization procedure |
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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 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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Difference in change of the titrated nasal provocation test between the two treatment groups. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
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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Patient will be treated at least 16 weeks (at least 12 weeks for subjects with hazel and alder allergy). Last visit must be performed before the birch pollen season starts (March 2010).
End of trial is defined by last visit of the last patient. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |