E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Immediate type allergy to soy proteins in patients with birch pollinosis |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10057630 |
E.1.2 | Term | Protein allergy |
E.1.2 | System Organ Class | 10021428 - Immune system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066093 |
E.1.2 | Term | Birch pollen allergy |
E.1.2 | System Organ Class | 10021428 - Immune system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10016946 |
E.1.2 | Term | Food allergy |
E.1.2 | System Organ Class | 10021428 - Immune system disorders |
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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 |
To determine the efficacy of specific subcutaneous immunotherapy (SCIT) against birch allergen Bet v 1 on birch pollen associated soy allergy. |
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E.2.2 | Secondary objectives of the trial |
To determine the efficacy of SCIT against birch allergen Bet v 1 on • Reactivity in SPT to soy • Levels of IgE and IgG4 for Bet v 1, Gly m 4, purified birch associated food allergens (apple, carrot, celeriac, cherry, hazel) • Food Allergy related Quality of Life Questionnaire
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male or female adult patients aged 18 – 65 years inclusive, legally competent • Written informed consent • Suspected birch pollinosis • Sensitization to birch pollen as demonstrated by positive SPT to birch (wheal > 3mm) • Specific IgE for Bet v 1 (> ImmunoCAP class 2) and Gly m 4 (> ImmunoCAP class 1) to be determined in laboratory at trial site (Investigation 2) • Clinical relevance of Gly m4 sensitization as demonstrated by positive DBPCFC to soy proteins (Investigation 4)
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E.4 | Principal exclusion criteria |
• SIT against birch within last 5 years • Ongoing SIT against any other allergen • Immediate indication of SIT against birch because of lacking effectiveness of moderate antiallergic therapeutic procedures (i.e. antihistamines) during birch pollen season • Pregnancy, lactation period or female patients seeking to become pregnant during interventional period • PEF oder FEV1 < 80% of predicted normal or uncontrolled bronchial asthma according to GINA 2006 • Febrile infections or inflammation of the respiratory tract at the time of inclusion • Irreversible secondary lung alterations (i.e. emphysema, bronchiektasia) • Severe acute or chronic diseases, severe inflammatory diseases • Other severe generalised diseases (liver, heart, kidney, metabolic disorders) • Severe autoimmune diseases, immune defects including immunosuppression, immune-complex induced immunopathies. Investigator may decide to take advice from other medical disciplines (i.e. immunologist, rheumatologist, endocrinologist) in case of uncertainty of severity and clinical relevance of autoimmune diseases • Severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse) • Completed or ongoing long-term treatment with tranquilizer or psycho active drugs. • Predictable need for long term (>5d) systemic glucocorticosteroid therapy > 7.5 mg prednisolone equivalent during interventional period (i.e. during pollen season) • Concurrent participation in any other clinical trial or participation in any other clinical trial during the previous 30 days • Low compliance or inability to understand instructions/study documents • Completed or ongoing treatment with anti-IgE antibody • Contraindication for adrenaline, (e.g. acute or chronic symptomatic coronary heart disease, severe arterial hypertension) • Therapy with betablockers topically or systemically
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E.5 End points |
E.5.1 | Primary end point(s) |
Threshold dose of soy protein leading to first symptoms at DBPCFC (lowest observed adverse effect level - LOAEL); two primary endpoints (without hierarchy) - LOAELobj for clinically objective and LOAELsubj for subjective symptoms |
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E.5.2 | Secondary end point(s) |
Effects of SCIT on • Overall rates for the occurrence of any objective symptoms pre / post SCIT per group • Cumulative VAS scores regarding the overall discomfort of patients in terms of DBPCFC pre / post SCIT per group • reactivity to soy protein in skin prick test (as measured in mm of wheal reaction) • specific IgE levels for Bet v 1and Gly m4 (as measured in kU/l) • specific IgE levels for purified birch associated food allergens (apple- Mal d 1, carrot- Dau c1, cherry- Pru av 1, celeriac- Api g1, hazel- Cor a 1;as measured in kU/l) • specific IgG4 levels for Bet v 1and Gly m4 (as measured in kU/l) • specific IgG4 levels for purified birch associated food allergens (apple- Mal d 1, carrot- Dau c1, cherry- Pru av 1, celeriac- Api g1, hazel- Cor a 1; as measured in kU/l) • Food allergy-related quality of life as measured via FAQLQ questionnaire including the FAIM questionnaire. • patient’s and investigator’s judgment whether verum or placebo SCIT was applied to a patient (before un-blinding the allocation of treatment arm).
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
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 | 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.8.4.1 | Number of sites anticipated in Member State concerned | 13 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 13 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
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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last patient out: october 2012 - in regard to experimental intervention with rBet v1-FV last patient out: march 2013 - in regard to experimental intervention with rBet v1-FV followed by final control examinations |
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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 | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |