E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
IgE-mediated allergic disease in adults and children manifested as bronchial asthma (GINA II and III) +/-allergic rhinitis/rhinoconjunctivitis, triggered by non-eliminable house dust mite 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 |
To evaluate efficacy and tolerability of specific immunotherapy with an aluminium hydroxide-adsorbed allergoid preparation of major allergens of D. pteronyssinus |
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E.2.2 | Secondary objectives of the trial |
Nonspecific bronchial hyperreactivity: change of PD20 FEV1 Immunologic changes: specific IgE, IgG1, IgG4 Changes in symptoms before versus after treatment Changes in use of bronchodilator rescue medication (Salbutamol) before versus after treatment Change in pre-bronchodilator morning peakflow before versus after treatment
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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 clinically relevant sensitation against house-dust mite allergens manifested as bronchial asthma (GINA grade II and III) +/- allergic rhinitis/rhinoconjunctivitis verified by: Full reversibility of FEV1 Asthma symptoms according to GINA II or III on exposure to house-dust mites Positive Prick Test reaction to D.pter. Positive RAST/CAP to D. pter. at least Class 2 Positive conjunctival provocation test result against D.pter. Requirement of asthma treatment with inhaled short-acting ß2-agonist and Requirement of inhaled corticosteroid treatment
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E.4 | Principal exclusion criteria |
Lung function: FEV1 < 80 % of predicted normal (ESCS) under optimum treatment Previous course of hyposensitation against house-dust or storage mites or any unknown allergen Unsuccessful course of specific immunotherapy with any allergen Specific immunotherapy with any other allergens during the course of the study Symptoms related to or skin test positivity to other perennial or seasonal allergens which interfere with the annual diary phases (Sept. 15th-February 15th): a) if clinically relevance cannot be excluded by provocation testing (alder, hazel, moulds) b) if allergen contact on more than 2 occasion monthly cannot be excluded (cat, dog)
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E.5 End points |
E.5.1 | Primary end point(s) |
Intraindividual changes of the minimum dose of inhaled corticosteroid to achieve asthma control (according to GINA criteria) compared with the period before treatment |
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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 | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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) | Yes |
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 | 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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Pharmacotherapy in children |
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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
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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 | 6 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial months | 1 |