| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| IgE-mediated allergic rhinoconjunctivitis with/without controlled bronchial asthma triggered by grass pollen allergens |
|
| 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 | 10048908 |
| E.1.2 | Term | Seasonal allergy |
|
| 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 efficacy and safety of specific im-munotherapy with a cocktail of recombinant major allergens of Timothy Grass Pollen (Phleum pratense) adsorbed onto aluminium-hydroxide in patients with IgE-mediated aller-gic rhinitis/rhinoconjunctivitis with or without controlled asthma. |
|
| E.2.2 | Secondary objectives of the trial |
| Changes of rhinoconjunctivitis specific Quality of Life at peak pollen season. Changes in specific conjunctival reactivity to grass pollen allergens. Changes of SMS after the first treatment year. Immunologic change in specific specific IgE, IgG1, IgG4 after the first and second treatment year. Safety of treatments during the entire study period. |
|
| E.2.3 | Trial contains a sub-study | Yes |
| E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
|
| E.3 | Principal inclusion criteria |
|  Male and female outpatients, 18 - 60 years  Patients suffering from IgE-mediated, moderate to severe seasonal allergic rhinitis with or without controlled bronchial asthma (PEF and/or FEV1 at least 80% predicted normal) attributable to grass pollen  In the course of the year: Major allergy symptoms during grass pollen season  Symptoms of allergic rhinoconjunctivitis against grass pollen allergens requiring medication during the last grass pollen season  Proven clinical relevance of grass pollen allergy by positive conjunctival provocation test (CPT) result using natural grass pollen cocktail  Positive skin prick test reaction to natural grass pollen allergens demonstrated by grass pollen allergen weal diameter  5mm (to be demonstrated in a valid skin prick test: Negative NaCl control weal  3 mm, positive Histamine (0.1%) control weal  3 mm)  Positive EAST to grass pollen  1.5 kU/L to be determined in central laboratory  For female patients: effective contraception and negative pregnancy test result. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectibles, combined or oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. No pharmacological interactions are known for hormonal contraceptives and specific immunotherapeutic preparations. |
|
| E.4 | Principal exclusion criteria |
|  Previous course of hyposensitisation against grass pollen or unknown other allergens in any pharmaceutical form  Patients who have undergone an unsuccessful course of specific im-munotherapy with any allergen  For allergens which interfere with the grass pollen season during May to August (Plantain, Nettle, Olive tree, Parietaria officinalis, Alternaria alternata, Cat epithelia, Dermatophagoides farinae, Dermatophagoides pteronyssinus):sensitisation in the Skin Prick Test: o Weal diameter of respective interfering allergen ≥ weal diameter of grass pollen allergen o Sensitisation as determined by serum EAST >1.5 kU/L  Clinical relevant sensitisation has to be excluded in a provocation test  Clinically relevant rhinoconjunctival or respiratory symptoms related to other reasons than allergy  PEF or FEV1< 80% of predicted normal (ECCS) or uncontrolled/partly controlled bronchial asthma according to the GINA Guidelines (2006)  Febrile infections or inflammation of the respiratory tract at the time of inclusion  Irreversible secondary alterations of the reactive organ (emphysema, bronchiectasis etc)  Severe acute or chronic diseases, severe inflammatory diseases  Other severe generalised diseases (Liver, kidneys, metabolic diseases)  Autoimmune diseases, immune defects including immuno-suppression, immune-complex-induced immunopathies  Severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse)  Completed or ongoing long-term treatment with tranquilizer psycho ac-tive drug  Allergy treatment according to severity of symptoms with other topical steroids than the following medication during the baseline grass pollen season: Levocabastine nasal spray/ eye drops (0.5 mg/ml each), Loratadine/Cetrizine tablets (10 mg), Salbutamol 100 micro-gram/puff) Treatment of exacerbation of allergic rhinoconjunctivitis and bronchial asthma with a short course of oral corticosteroids is permitted. Treatment with or other medication must be stopped 2 weeks prior to start of this study. Basic asthma treatment with other medication than short acting bronchodilatators  Any prophylactic and any treatment with antiallergic medication in fixed (constant) dosage during the baseline and any grass pollen seasons during the study  Pregnancy and lactation period  Female patients seeking to become pregnant  Concurrent participation in any other clinical trial or participation in any other clinical trial during the previous 30 days  Low compliance or inability to understand instructions/study docu-ments  Completed or ongoing treatment with Anti-IgE antibody  Patients being in any relationship of dependence with the sponsor and/or investigator  Contraindication for adrenaline, (e.g. acute or chronic symptomatic coronary heart disease, severe arterial hypertension)  Treatment with beta-Blockers, locally and systemically |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| The aim of this study is to establish superiority of perennial specific immunotherapy with an aluminium-hydroxide-adsorbed cocktail of re-combinant major allergens of Timothy Grass (Phleum pratense) over placebo. Changes of the Symptom Medication Score (SMS) from the baseline season to the season after 2 years of double-blind treatment will be evaluated |
|
| 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 | 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 | 4 |
| 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 | 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
|
| ultima visita dell'ultimo soggetto inserito nella sperimentazione |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 6 |
| E.8.9.1 | In the Member State concerned months | 0 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 6 |
| E.8.9.2 | In all countries concerned by the trial months | 0 |
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