E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Grass Pollen Related Allergic Rhinoconjunctivitis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10010744 |
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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 |
Main objective : To assess the long-term treatment efficacy and efficacy maintenance (carry-over effect) of SLIT on the: Rhinoconjunctivitis Total Symptom Score (RTSS) of the six rhinoconjunctivitis symptoms sneezing, rhinorrhea, nasal pruritis, nasal congestion, ocular pruritis and watery eyes. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives : To assess the long-term treatment efficacy and efficacy maintenance (carry-over effect) of SLIT on the: rescue medication usage (use of anti-histamine: nasal cortico-steroids and systemic oral cortico-steroids); six individual symptom scores of the rhinoconjunctivitis symptom score (RSS); proportion of symptom-free days; global evaluation by the patient. To continue documentation of the safety of the treatment.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Male or female outpatients, aged 18-46 years (inclusive) 2. Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons. 3. Sensitised to grass pollen (positive SPT and IgE level of at least Class 2) 4. Total symptom score on the RRTSS during the pollen season prior to the start of the V034.04 study of greater than or equal to 12. 5. Patients who are willing to comply with the protocol. 6. Patients must be in general good health as determined by past medical history, physical examination and safety laboratory tests. 7. Patients who have been informed of the nature and aims of the study and have given their written consent/ assent to participate in this study in accordance with local laws and requirements. 8. Patients must have been compliant with respect to the completion of the daily record card and taking of the investigational product during study V034.04.
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E.4 | Principal exclusion criteria |
1. Allergic rhinoconjunctivitis due to cosensitisation likely to significantly change the symptoms of the patient throughout the study or patients who have symptoms of rhinoconjunctivitis during the treatment phase due to sensitisation to allergens other than the grass pollens. 2. Pregnancy, breast-feeding/ lactation or sexually active women of child-bearing potential who are not using a medically accepted contraceptive method. 3. Asthma requiring treatment other than beta-2 inhaled agonists. Patients with intermittent asthma not necessitating inhaled or systemic corticoid treatment may be included. 4. Patients who have taken oral steroids 4 weeks prior to enrolment in this study. 5. Patients who have received desensitisation treatment for grass pollen (other than study V034.04). 6. Patients at risk of non-compliance. 7. Participation in any other clinical study since end of V034.04. 8. Patients with a new or current disease, which as judged by the investigator, may affect the patient’s participation in or the outcome of the study. These diseases include, but are not limited to, cardiovascular disease, malignanacy, hepatic disease, renal disease, haematological disease, neurological disease, immunological disease and endocrine disease. 9. Patients treated with beta-blockers since end of V034.04. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The average RTSS during the third pollen period is the primary efficacy endpoint for long-term treatment efficacy, and the average RTSS during the fourth pollen period is the endpoint for the assessment of the maintenance of efficacy (carry-over effect). The start date of each pollen period is defined as the first day with grass pollen count of at least 30/ m cubed of air at a center, and the end date is the last day with grass pollen count of at least 30/ m cubed of air. |
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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 | No |
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 | 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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 9 |