E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This clinical trial will evaluate the benefit of subcutaneous cluster immunotherapy with cluster-allergoid CLUSTOID® over placebo in patients with allergic rhinoconjunctivits. |
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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 assess the efficacy of a subcutaneous cluster immunotherapy with cluster-allergoid CLUSTOID® on a total combined score (TCS), taking into account a rhinoconjunctivitis total symptom score (RTSS) of the six rhinoconjunctivitis symptoms sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes and a total rescue medication score (TRMS), considering the use of cromone eye drops, oral antihistamines, nasal corticosteroids and leukotriene antagonists. |
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E.2.2 | Secondary objectives of the trial |
To assess the efficacy of a subcutaneous cluster immunotherapy with cluster-allergoid CLUSTOID® on the rhinoconjunctivitis symptom scores (RSS) sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes for the peak of the grass and rye pollen season and the global evaluation carried out by the patient for the total grass and rye pollen season and to document and assess the safety of the treatment.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients aged 18–75 with allergic rhinitis and/or allergic rhinoconjunctivitis with or without seasonal mild or moderate allergic asthma (GINA I and GINA II). • Positive clinical history of grass pollen. • Clinical sensitization to grass with or without additional sensitization to rye pollen. • Compliance and ability of the patient to complete a Diary Card • Signed and dated patient´s informed consent form. |
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E.4 | Principal exclusion criteria |
• Previous immunotherapy with grass or rye pollen extracts within the last 3 years, • Predominant perennial allergic rhinitis, • Predominant perennial allergic asthma, • Simultaneous participation in other clinical trials, • Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance), • Active tuberculosis, • Auto-immune disorders, • Severe chronic-inflammatory diseases, • Malignancy, • Alcohol abuse, • Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection, • Irreversible secondary disorders at the target organ (e.g. emphysema, bronchoectasis), • Patients treated with -blockers and/or other contra-indicated drug |
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E.5 End points |
E.5.1 | Primary end point(s) |
The efficacy is to be evaluated by assessing the mean in the total combined score (TCS), taking into account the RTSS and the TMRS, during the peak pollen season. |
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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 | 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) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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 | No |
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 | 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 | 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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The duration of the study is one year. |
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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 | |