E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type I respiratory hypersensitivity to cross-reacting grass pollens |
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MedDRA Classification |
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 |
The primary objective of this study is to compare the efficacy of GrassMATAMPL versus placebo as measured by the combined allergy symptom (eyes and nose)/medication scores self-reported by subjects during the 4 peak weeks of the 2007 grass pollen season. |
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E.2.2 | Secondary objectives of the trial |
Efficacy: To compare combined symptom (lungs) /medication scores, combined symptoms (TSS: eyes and nose), individual symptoms (TSS eyes, TSS nose, and TSS lungs) and relief medication use (eyes and nose combined, and lungs); each during the 4 peak weeks of and the entire 2007 grass pollen season.
To compare the combined allergy symptom (eyes and nose)/medication scores during the entire 2007 grass pollen season, specific immunological changes (grass specific IgE and IgG), change in quality of life (RQLQ(S)), change in global health assessment, change in Allergy Specific Global Health Assessment (visual analog scale) and number of days absent from school, work, and/or normal activities due to allergic symptoms.
Safety: To compare frequency of adverse events, frequency of adverse reactions (total of local or systemic/generalized events experienced by a subject within 24 hour period after injection) and changes in clinical lab values, ECG, and vital signs.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Subjects will be considered for enrollment in the study if they: 1.Have given written informed consent; 2.Are 18 to 59 years of age; 3.Have history of moderate to severe symptoms of seasonal allergic rhinitis and/or conjunctivitis ascribed to grass pollen exposure that required repeated use of antihistamines, nasal steroids, and/or leukotriene modifiers; 4.Have a history of moderate to severe symptoms in the past grass pollen season as determined by a score of ≥ 5 on the Disease Severity Questionnaire; 5.Have a positive skin prick test to grass pollen mix [wheal (longest diameter) ≥ 5 mm greater than the negative control] and a positive RAST or equivalent test (class ≥ 2) to grass pollen mix; 6.Have a positive skin prick test to histamine [wheal (longest diameter) of ≥ 3 mm greater than the negative control]; 7.Have a negative skin prick test to the negative control (redness with wheal ≤ 2 mm is acceptable); 8.Have a forced expiratory volume in 1 second (FEV1) ≥ 80% of predicted, with a FEV1/FVC ratio ≥ 70%; 9.Women of childbearing potential must be using a medically acceptable method of birth control [i.e., stable hormonal contraceptive for ≥ 90 days prior to the study or hormonal contraceptive in addition to use of double barrier method of contraception (e.g., intrauterine device and condom, spermicide and condom), sexual abstinence or have a vasectomized partner until study completion], and have a negative β-HCG pregnancy test result at Visits 1, 2 and 5; 10.Are able to understand and comply with study instructions. 11.Demonstrate proper use of electronic diary with at least 85% compliance (i.e., correct entries for symptoms on 6 of 7 days) during the 1-week period between Visit 1 and Visit 2.
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E.4 | Principal exclusion criteria |
Subjects will be excluded from the study for any of the following: 1.Pregnant or lactating 2.Asthma requiring daily use of controller medication 3.Had emergency room visit or admission for asthma in 12 months prior to Visit 1 4.Presence of secondary alteration at the affected organ (i.e., emphysema, bronchiectasis, nasal polyps, chronic sinusitis) 5.Auto-immune disease (e.g., liver, kidney, thyroid, nervous system) 6.Acute or subacute (historic) atopic dermatitis, chronic dermatitis, urticaria factitia, and/or urticaria due to physical/chemical influence or any other skin conditions which might interfere with interpretation of skin prick test results 7.History or presence of diabetes (insulin dependent and non insulin dependant), cancer or concomitant illness that, in opinion of Investigator, would pose safety risk or compromise interpretation of efficacy. 8.History of angioedema 9.Manifest pulmonary or cardiac insufficiency; 10.Current malignant disease; 11.Disorders of tyrosine metabolism (i.e., alcaptonuria, tyrosinemia); 12.Acute or chronic infection; 13.Clinically significant abnormal lab value (as determined by Investigator) at Visit 1 14.Perennial Allergens: Positive skin prick test [wheal (longest diameter) ≥ 3mm greater than negative control] at Visit 1 to: house dust mites (Dermatophagoides pteronyssinus and Dermatophagoides farinae), molds (Cladosporium cladosporioides, Alternaria alternata, Penicillium chrysogenum, and Aspergillus fumigatus), or epithelia (cat, dog, and horse) and history of moderate or severe symptoms when exposed to the aforementioned allergens. 15.Springtime Flowering Plant Allergens: Applies only to subjects living in geographic areas where springtime flowering plant season and grass season overlap and/or when treatment phase cannot be completed at least 30 days prior to the start of the springtime flowering plant season. Positive skin prick test [wheal (longest diameter) ≥ 3mm greater than the negative control] at Visit 1 to: birch (Betula sp), oak (Quercus sp.), sycamore (Platanus sp.), beech (Fagus sp.), ash (Fraxinus sp.), or poplar (Populus sp.) and history of moderate or severe symptoms when exposed to the aforementioned allergens. 16. Inadequate washout period prior to screening (Visit 1) 17. Require use of beta blockers 18. Unable to receive epinephrine therapy (i.e., use of epinephrine is contraindicated) 19. History of anaphylactic reactions to foods, insect venom, exercise, or drugs 20.Treated with a preparation containing MPL® within 6 months prior to Visit 1 21. Have diseases with a pathogenesis interfering with the immune response, and who have received medication which could interfere with study results 22. History of allergy, hypersensitivity or intolerance to the excipients of study medication; 23.History of allergy, hypersensitivity or intolerance to study relief medication 24.Already undergone hyposensitisation therapy with comparable allergen extracts 25.Participated in a clinical research trial with a new chemical substance within 4 weeks of Visit 1; 26.Unable or unwilling to cooperate with Investigator and to comply with the protocol requirements or unlikely to complete observation periods sufficiently 27.Have changed residence between geographical regions within the past 3 months.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy measure in this study will be the combined symptom (eyes, nose) and medication score during the 4 peak weeks of the grass pollen season. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
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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The end of the trial is defined as the last visit of the last patient |
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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 | 13 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 13 |