E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Allergic diseases such as rhinoconjunctivitis or bronchial asthma are a major public health burden. The huge associated costs demand an evidence based therapeutic aproach. The only available causative therapy is the specific immuno-therapy (SIT). Auto-vaccine is another biogen substance, which derives from human-GI-tract bacteria. Its subcutaneous administration results in a Th-1 driven shift towards immunotolerance. |
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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 |
Proove of concept for the efficacy of autologous autovaccine in the therapy of house dust mite allergy in adults. Determination of exhalative NO (eNO) as a marker of bronchial inflammation. Under the influence of the verum, we expect versus placebo a significant blockade of the synthesis of eNO. |
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E.2.2 | Secondary objectives of the trial |
Bronchial hyperresponsiveness will be determined by metacholin testing, a routine procedure in clinical praxis. Autovaccine-reated subjects are expected to show a reduced bronchial response towards inhalationof house dust mite-solution. Other markers to assess bronchial inflammation will be sputum eosinophilia, and for systemic inflammation and allergic sensitization the determination of CD63, lipoprotein binding protein, and IgE |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
otherwise healthy adults with house dust mite allergy prooven by positive prick test and bronchial provocation (FEV1 decrease > 20%). Episodic bronchial asthma (GINA 0-I°). Informed consent. |
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E.4 | Principal exclusion criteria |
allergies towards ingredients of the autovaccine. Bronchial asthma > GINA I°, other chronic diseases. Pregnancy. |
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E.5 End points |
E.5.1 | Primary end point(s) |
a significant reduction of eNO in the autovaccine treated group. |
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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 | Yes |
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) | 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
| 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 | 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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The end of the trial is the final examination (see scetch "Versuchsablauf"/flow sheed of the trial). The "intervention period" consists of a total of 36 injections (auto-vaccine or placebo) over 29 weeks, followed by a 4 weeks break. The "house dust mite challenge" includes 4 bronchial provocations, determination of eNO, and metacholin-testing within one week. The final examination is meant to document the effect of autovaccine immunotherapy. |
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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 |