Status:
COMPLETED
Different Doses of Tyrosine Adsorbed Grass Pollen Allergoid With Monophosphoryl Lipid A (MPL) in Patients Sensitized to Grass Pollen
Lead Sponsor:
Allergy Therapeutics
Conditions:
Type I Hypersensitivity
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
Allergen-specific immunotherapy (SIT), the administration of gradually increasing quantities of an allergen extract to an allergic patient, is a curative approach which directly treats the underlying ...
Eligibility Criteria
Inclusion
- positive skin prick test for grass and rye allergen
- Specific IgE for grass and rye as documented by radioallergosorbent or equivalent test with class \>= 2
- History of at least 1 season of moderate to severe seasonal rhinoconjunctivitis due to an IgE - mediated allergy to pollen from grass and rye
- Males or non-pregnant, non-lactating females who are post-menopausal or naturally or surgically sterile. Females of childbearing potential have a confirmed absence of pregnancy according to a negative urine pregnancy test and must be using an acceptable birth control method.
- Spirometry at Screening demonstrates FEV1 \>= 80% predicted and FEV1/FVC \>= 70%
Exclusion
- Acute or subacute atopic dermatitis and/or urticaria factitia and/or urticaria due to physical or chemical influence and/or chronic dermatitis
- Patient has moderate to severe asthma
- Visual inspection of the forearms indicates potential problems with the conduct or interpretation of the skin prick test; both forearms must be available for testing
- History or presence of diabetes, cancer or any clinically significant cardiac, metabolic renal, hematologic diseases or disorders
- Recent clinically significant history (within 2 years) of hepatic gastrointestinal, dermatologic, venereal, neurologic or psychiatric diseases or disorders
- Any clinically significant (as determined by the investigator) abnormal laboratory value
- Perennial allergens: clinically relevant sensitivity against house dust mites, molds, and epithelia
- Patient has clinically relevant sensitivity against the following summer/autumn season flowering plants: plantain, orache, nettle, mugwort, Bermuda grass, or ragweed.
- Secondary alteration at the affected organ
- History of autoimmune diseases and/or rheumatoid diseases
- Patient is taking b-blockers
- Patient who is not allowed to receive adrenalin
- Patients in whom tyrosine metabolism is disturbed
- Presence of a disease with a pathogenesis interfering with the immune response and patient has received medication which could influence the results of this study
- Documented evidence of acute or significant chronic infection
- History of anaphylaxis
- Documented history of angioedema
- Hypersensitivity to excipients in the study medications
- Previous or current immunotherapy with comparable grass/rye allergen extracts
- Currently using anti-allergy medication and other drugs with antihistaminic activity
- Patients currently participating in a clinical trial or who have been exposed to study medication within the last 30 days
- Patient is pregnant or planning pregnancy and/or lactating
- Patient has received treatment with preparation containing MPL® during the past 12 months
- Any systemic disorder that could interfere with the evaluation of the study medication(s)
- Clinical history of drug or alcohol abuse that would interfere with the patient's participation in the study
Key Trial Info
Start Date :
September 12 2005
Trial Type :
INTERVENTIONAL
End Date :
November 8 2005
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00133159
Start Date
September 12 2005
End Date
November 8 2005
Last Update
May 18 2021
Active Locations (3)
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1
Allied Research International Inc.
Mississauga, Ontario, Canada, L4W 1N2
2
Mississauga, Ontario, Canada, L5B 1N1
3
Ottawa Allergy Research Corporation
Ottawa, Ontario, Canada, K1Y 4G2