E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Allergic rhinoconjunctivitis caused by grass pollen |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039085 |
E.1.2 | Term | Rhinitis allergic |
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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 if treatment compliance to Grazax in adult subjects affected by allergic rhinoconjunctivitis caused by grass pollen can be improved giving an electronic device Memozax to patients from the beginning of the trial or 6 months after starting treatment |
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E.2.2 | Secondary objectives of the trial |
To evaluate tolerability and safety of Grazax To evaluate tolerability and safety of Grazax at the first dose To evaluate impact on quality of life, on rhinitis symptomathology score, after one year treatment with Grazax, compared to the previous pollen season. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Male and Female, aged between 18 and 65 years Moderate/severe intermittent rhinoconjunctivitis or mild-moderate persistent rhinoconjunctivitis according to ARIA diagnostic criteria Positive Skin Prick Test wheal diameter larger than 3mm to grass pollen allergen Phleum pratense No clinically relevant pathologies In case of child bearing potential women, a negative pregnancy Test is required at enrollment and tha subject must use an appropriate contraceptive methods for the whole duration of the trial Written Informed Consent |
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E.4 | Principal exclusion criteria |
Signs and Symptoms of acute infection to upper respiratory tract and /or acute otitis, and/or acute sinusitis at enrollment Admission in Emergency ward for ashtma attack during 12 months defore Visit 1 Past specific immunotherapy for allergens other than grass pollen during the past 2 years Past anaphylactic reactions food allergy, insect bites, drug allergy, anaphylaxis induced by exertion and/or angioedema Subject treated with immunosuppressive drugs Hypersensibility to tablets excipients |
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E.5 End points |
E.5.1 | Primary end point(s) |
The effect on treatment compliance related to the use of device that allows to check therapy adherence |
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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 | Yes |
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 | Information not present in EudraCT |
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 | 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) | 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 | 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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Stesso farmaco con device elettronico Memozax |
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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 | 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
| |
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 | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |