Type I respiratory hypersensitivity to cross-reacting grass pollens
Conditions
Interventions
Product Name: Grass MATA MPL
Product Code: Grass MATA MPL
Pharmaceutical Form: Suspension for injection
Current Sponsor code: Aqueous Modified Allergen
Sponsors
Allergy Therapeutics (UK) Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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. double barrier method of contraception (e.g., intrauterine device and condom, spermicide and condom), stable hormonal contraceptive for = 90 days prior to the study or if =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 dependent), 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/plane (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; 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.; Secondary Objective: Efficacy: To compare combined symptom (lungs) /medication scores, combined symptoms (TSS: eyes and nose), individual symptoms (TSS eyes, TSS nose & TSS lungs) & relief medication use (eyes & nose combined & lungs); each during the 4 peak weeks of and during the entire 2007 grass pollen season. To compare the combined allergy symptom (eyes & nose)/medication scores during the entire 2007 grass pollen season, specific immunological changes (grass specific IgE & 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. See protocol pg 32 for further details Safety: To compare frequency of AEs, 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. ;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. | — |
Countries
Austria, United Kingdom
Outcome results
None listed