E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
IgE-mediated allergic disease in adults manifested as rhinitis/ rhinoconjunctivitis and/or allergic asthma bronchiale (GINA I and II) 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 |
·Change of AUC of SMS after 1 year of treatment to baseline ·Immunologic changes: Allergen specific IgE, IgG1 and IgG4 ·Change of nasal ECP level after 2 years of treatment (only in selected trial centres) to baseline ·Tolerability and safety will be assessed during the initial treatment phase and after each injection by evaluating adverse events and other parameters.
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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 allergic rhinitis/rhinoconjunctivitis with or without bronchial asthma (GINA grade I and II), triggered by house dust mites, documented by means of: ·Positive EAST > 2 to housedust mites, measured by Central Lab and ·Positive prick test reaction to D. pter ·Determination of the nasal airflow recovery after decongestion performed by PNIF For enrolment into the study the patients PNIF after nasal decongestion must be > 100 l/s and an improvement of > 25% after topical nasal decongestion ·positive conjunctival provocation test result against D. pter. allergen extract ·positive house dust mite allergen or microscopic mite determination in bed of the patients living area ·For patients with allergic asthma bronchiale: therapy with max. 500 µg BDP/-equivalent per day and/or ß2- Mimetics when needed should be sufficient ·After the 3 month baseline period only those patients will be included in the treatment phase who demonstate adequate symptomatic in the diary
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E.4 | Principal exclusion criteria |
·Previous course of hyposensitation against house-dust or storage mites or any unknown allergen ·Patients that have undergone an unsuccessful course of SIT with any allergen ·SIT 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 (October - January): ·Irreversible nasal obstruction caused by nasal structural anomalies. ·Clinically relevant rhinitis/rhinoconjunctival or respiratory symptoms related to other reasons that have not been clearly identified ·FEV1 < 80 % of predicted normal (ECCS) ·bronchial asthma (GINA III + IV) ·Any prophylactic and constant dosage during the diary phase with antiallergic medication ·Previous or ongoing use of anti-IGE antibodys ·Contra-indications for application of adrenaline: -Severe acute or chronic symptomatic coronary heart disease -Severe arterial hypertension ·Treatment with beta-Blockers ·Allergy treatment according to severity of symptoms with other than the following medication during the diary phase: levocabastine nasal spray (0,5 mg/ml each), loratadine/cetirizine tablets (10 mg), oxymetazoline spray 0.05%. Exacerbation treatment with a short course of oral corticosteroids. Unchanged basic treatment with inhaled corticosteroids up to 500 µg BDP/-equivalent and the use of ß2-mimetics as needed is permitted in asthmatics.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of this study is the change of the area under the curve (AUC) of the Symptom-Medication-Score (SMS) after 2 years of double-blind treatment to baseline. For this purpose patients will carefully complete a diary over a time period of anticipated 3 months in the winter time of 2006/2007 and six weeks during winter time 2007/2008 and 2008/2009. A Symptom-Medication-Score (SMS) will be calculated by the daily sum of allergic symptoms and the daily sum of additional antiallergic medication intake. The accurate keeping of the diary will be checked by the investigator. A predefined diary phase will be used for assessment of clinical efficacy. Further details will be defined in the statistical analysis plan (SAP). |
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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 | 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.8.5 | 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 | 0 |
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 | 0 |