E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
IgE-mediated allergic disorders |
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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 aim of the study is to show that a rush-in initial phase of 5 days with SUBLIVAC® is as safe as a conventional initial phase of 15 days. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
·Subject selected to be treated with SLIT. ·Male or female, age ³ 8 years. ·Subject with rhinitis or rhinoconjunctivitis ·The allergy should be confirmed by, for example, a positive SPT (mean wheal diameter > 3 mm) or specific serum IgE-test (RAST ≥ 2). ·Subject must be willing to follow all study procedures including attendance at practise for scheduled study visits and compliance with study treatment regimen. ·Subject must give a written informed consent (IC). |
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E.4 | Principal exclusion criteria |
·Chronic asthma or emphysema, particularly with a FEV1 < 70% of predicted value. ·Serious immunopathologic diseases or malignancies (including auto-immune diseases, tuberculosis). ·Symptomatic coronary heart diseases or severe (even under treatment) arterial hypertension. ·Diseases with a contra-indication for the use of adrenaline. ·Severe kidney disease. ·Use of systemic steroids. ·Treatment with β-blockers or ACE inhibitors or immunosuppressive drugs. ·Active infection of the target organ. ·Severe atopic dermatitis. ·Participation in a clinical study with a new investigational drug within 3 months prior to enrolment. ·Pregnancy, lactation or inadequate contraceptive measures. ·Alcohol- or drug abuse. ·Lack of co-operation or severe psychological disorders. ·Other serious or unstable medical or psychological condition that, in the opinion of the investigator, would compromise the subject’s safety or successful participation in the trial. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The percentage of subjects reaching the maintenance dose according the rush regime compared to the conventional regimen. |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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 | Information not present in EudraCT |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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
| |
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 |