E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
grass pollen rhinoconjunctivitis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | PT |
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 assess the sustained clinical effect and post-treatment long-term efficacy of SLIT for grass pollen allergens on: - The Average Adjusted Symptom Score (AASS): A score taking into account the daily Rhinoconjunctivitis Total Symptom Scores (RTSSs) and rescue medication use. |
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E.2.2 | Secondary objectives of the trial |
To assess the sustained clinical effect and post-treatment long-term efficacy of SLIT for grass pollen allergens on:
The Average Rhinoconjunctivitis Total Symptom Score (ARTSS) of the six rhinoconjunctivitis symptoms sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes. The Average Rescue Medication Score (ARMS) and use of rescue medication (antihistamine [oral form or / and eye drops], nasal corticosteroid and oral corticosteroid). The Average Combined Score (ACS): A score taking into account the Rhinoconjunctivitis Total Symptom Score (RTSS) and Rescue Medication Score (RMS). Each of the six individual Average Rhinoconjunctivitis Symptom Scores (ARSS). The Overall Rhinoconjunctivitis Quality of Life Questionnaire Score (RQLQ). The proportion of symptom-controlled days (PSCD). The global evaluation of the efficacy of sublingual tablets of grass pollen allergen extract by the patient.
To document the safety of the treatment. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male or female outpatients aged 18 to 50 years (inclusive). • Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons. • Sensitised to grass pollen (positive skin prick test and IgE level of at least Class 2). • Total symptom score on the Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) during the previous pollen season of greater than or equal to 12 out of a possible score of 18. • Female patients of childbearing potential must be willing and able to sign written informed consent stating that they will use appropriate contraception and not plan a pregnancy for the first 3 years of this study.
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E.4 | Principal exclusion criteria |
• Patients with symptoms of rhinoconjunctivitis during the grass pollen season due to sensitisation to allergens other than grass pollen may not be included. Patients must be asymptomatic to all other allergens during the grass pollen season. Patients who have allergic rhinitis due to perennial allergen may not be included. • Asthma requiring treatment other than beta-2 inhaled agonists. • Patients who have received desensitisation treatment for grass pollen.
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E.5 End points |
E.5.1 | Primary end point(s) |
The AASS while on treatment during the third pollen period is the primary efficacy endpoint for the sustained clinical effect, and the AASS during the fourth and fifth pollen periods is the endpoint for the assessment of the post-treatment long-term efficacy. |
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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 | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
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.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 44 |
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 | No |
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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Last patient's 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 | 4 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |