Status:
COMPLETED
Assessment of Residual Allergenicity of Grass/Rye Pollen Allergoid Using Skin Prick Testing
Lead Sponsor:
Allergy Therapeutics
Conditions:
Type I Hypersensitivity
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the residual allergenicity of Grass MATA (modified pollen allergen tyrosine adsorbate) by skin prick testing. This is done by a comparison of the wheal respons...
Detailed Description
Grass MATA MPL has been developed to provide pre-seasonal specific immunotherapy for patients with proven type I hypersensitivity to cross reacting grass pollens. MPL (Monophosphoryl Lipid A), a puri...
Eligibility Criteria
Inclusion
- Positive skin prick test to grass and rye pollen allergen extract
- Positive skin prick test to positive histamine control
- Negative skin prick test to negative control
- Specific IgE for grass and rye as documented by a RAST or equivalent test
- Females of childbearing potential may enter the study if they have a negative urine pregnancy test and they have been practicing adequate contraception for 3 months prior to the study and continue to do so during the study.
Exclusion
- History or presence of acute or subacute atopic dermatitis, chronic dermatitis, urticaria factitia, or urticaria due to physical/chemical influence or any other skin conditions which might interfere with the interpretation of skin prick test results
- Visual inspection of the forearms indicates potential problems with the conduct or interpretation of the skin prick tests; both forearms must be available for testing
- Subject has bronchial asthma or other lower respiratory tract condition (i.e., emphysema, bronchiectasis)
- History or presence of diabetes, cancer or any clinically significant cardiac, metabolic, renal, hepatic, gastrointestinal, dermatologic, venereal, hematologic, neurologic or psychiatric diseases or disorders
- Any clinically significant abnormal laboratory value at Visit 1
- Clinically relevant sensitivity to any common perennial allergen: house dust mites, molds, or epithelia (cat, dog, and horse). Sensitivity will be determined by a skin prick test at Visit 1, a RAST (or equivalent method) at Visit 1, or a documented history of symptoms to perennial allergens. Subjects may be enrolled in the study if they test positive, but have no current or historical symptoms to perennial allergens.
- Clinically relevant sensitivity to any common springtime flowering plant: Birch, Oak, Sycamore, Beech, Ash, and Poplar.
- Sensitivity will be determined by a skin prick test at Visit 1, a RAST (or equivalent method) at Visit 1, or a documented history of symptoms to springtime (non-grass/rye) allergens. Subjects may be enrolled in the study if they test positive, but have no current or historical symptoms to these springtime allergens.
- History of auto-immune diseases or rheumatoid diseases
- Subject not allowed to receive adrenalin
- Subject has disorder of tyrosine metabolism (i.e., alcaptonuria, tyrosinemia)
- Subject with diseases interfering with the immune response and have received medication, which could influence the results of this study
- Subject has acute or chronic infection
- History of anaphylaxis, including anaphylactic food allergy, insect venom anaphylaxis, exercise or drug induced anaphylaxis
- History of angioedema
- History of hypersensitivity to the excipients of the study medication
- History of immunotherapy with grass allergen extracts
- Current therapy with ß-blockers
- Currently receiving anti-allergy medication or other drugs with an antihistaminic activity
- Subject has a positive drugs of abuse screen at Visit 1
- Subject participated in a clinical trial with an investigational drug within the last 3 months
- Subject cannot communicate reliably with the Investigator or is not likely to cooperate with the requirements of the study
- Subject is pregnant or lactating
- Subject received treatment with a preparation containing MPL during the past 12 months
- Use of prohibited medications or inadequate washout periods prior to screening
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00104390
Start Date
March 1 2005
End Date
April 1 2005
Last Update
June 10 2010
Active Locations (1)
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1
Allergy Associates Research Center
Portland, Oregon, United States, 97213