E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Grass pollen allergic rhinoconjunctivitis |
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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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
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 evaluate the efficacy and safety of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season compared with placebo for reduction of rhinoconjunctivitis symptoms and rescue medication usage.
Primary Efficacy Objective: To assess the efficacy of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season on: - The Average Adjusted Symptom Score (AASS). A score taking into account the Rhinoconjunctivitis Total Symptom Score (RTSS) and rescue medication use
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E.2.2 | Secondary objectives of the trial |
Secondary Efficacy Objectives: To assess the efficacy of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season on: - The Average Rhinoconjunctivitis Total Symptom Score (ARTSS) of the six rhinoconjunctivitis symptoms sneezing, rhinorrhoea, 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 RTSS and Rescue Medication Score (RMS). - Each of the six individual Average Rhinoconjunctivitis Symptom Scores (ARSS). - 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 |
Patients must meet all of the following inclusion criteria in order to participate in this study: 1. Written consent / assent (as applicable). 2. Male or female outpatients aged 12 to 65 years (inclusive). 3. Patients with grass pollen-related allergic rhinoconjunctivitis for at least the last two grass pollen seasons. 4. Positive SPT (wheal diameter greater than 3 mm) and grass pollen-specific IgE values of at least 0.70 kU/L. 5. An RRTSS during the previous pollen season of greater than or equal to 12 out of a possible 18. The RRTSS is an evaluation (by the patient) of the most severe symptoms during the previous pollen season. 6. Patients in general good health as determined by the medical history, physical examination (including vital signs) and safety laboratory tests. 7. Patients with FEV1 ≥ 80% of the predicted value. 8. Female patients are eligible if they do not have child bearing potential. Female patients are considered not to have child-bearing potential before their menarche, at least 2 years after menopause or if they have had a total hysterectomy or bilateral oophorectomy. 9. Female patients of child-bearing potential are eligible if they are not sexually active or if they: Use a medically accepted contraceptive method (hormonal birth control [orally, injectable or by implant, for at least 2 months before enrolment], intrauterine device, spermicide used with a male condom, bilateral tubal ligation, diaphragm with spermicide, female condom, monogamous relationship with a vasectomised partner), and Have a negative urine pregnancy test. 10. Patients who are able to understand the information given, and will be compliant with the protocol including investigational product administration and visit schedules. Adult patients should also be able to complete the daily record card.
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E.4 | Principal exclusion criteria |
Patients must not meet any of the following exclusion criteria in order to participate in this study: 1. Positive SPT to any other seasonal allergens present during the grass pollen season including olive and cypress pollen if these allergens are endemic to the region. 2. Patients with clinically significant confounding symptoms of allergy to other allergens potentially overlapping the grass pollen season (for example, tree allergens). 3. Significant symptomatic perennial allergy due to an allergen to which the patient is regularly exposed. 4. Patients with moderate or severe persistent asthma (GINA 3 or 4). 5. Patients with seasonal mild persistent asthma (GINA 2) necessitating treatment with inhaled glucocorticosteroids at a dose level greater than 400 mcg budesonide dose-equivalents. 6. Patients who have received any desensitisation treatment for grass pollen in the last 5 years. 7. Patients with ongoing treatment by immunotherapy with any other allergen. 8. Patients with any nasal or oral condition that could confound the efficacy or safety assessments such as nasal polyposis, chronic sinusitis or oral inflammation (for example oral lichen planus, oral ulceration or oral mycosis). 9. Patients with a known history of hypersensitivity or intolerance to any of the excipients in the investigational product (such as galactose intolerance). 10. Patients with any past or current clinically significant condition which as judged by the investigator, may affect the patient's participation or the outcome of the study. These may include, but are not limited to, anaphylaxis with cardio-respiratory symptoms, chronic urticaria and angioedema, severe atopic dermatitis, malignancy, and cardiovascular, hepatic, renal, haematological, neurological, immunological and endocrine diseases. 11. Patients treated with systemic, nasal or inhaled corticosteroids within 4 weeks before Visit 1 or with long acting systemic corticosteroids within 12 weeks before Visit 1, whatever the indication. 12. Patients treated or under treatment with beta-blockers, continuous systemic corticotherapy or immunosuppressive drugs. 13. Pregnant, breastfeeding, or sexually active females who are not using a medically accepted contraceptive method as listed above. 14. Patients participating or having participated within 12 weeks before Visit 1 in any clinical study. 15. Patients who are likely to be unable to complete the study for any reason, or patients who have to travel for extended periods of time during the grass pollen season which in the opinion of the investigator will compromise the data. 16. Patients with a history of drug or alcohol abuse. 17. Investigators, sub-investigators and study staff as well as their children or spouses and family members should not be enrolled in the study. 18. Patients must not be randomised in this study more than once.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable is the Average Adjusted Symptom Score (AASS) during the pollen period while on treatment. The AASS score takes into account the Rhinoconjunctivitis Total Symptom Score (RTSS) and rescue medication use
The study assess the efficacy of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season on: - The Average Adjusted Symptom Score (AASS). A score taking into account the Rhinoconjunctivitis Total Symptom Score (RTSS) and rescue medication use.
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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 | 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.8.4.1 | Number of sites anticipated in Member State concerned | 18 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 42 |
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 | 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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 8 |