Status:
COMPLETED
Assessment of Residual Allergenicity of Tree (Birch, Hazel, and Alder) 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 Tree MATA (modified pollen allergen tyrosine adsorbate) by skin prick testing. This is done by a comparison of the wheal response...
Detailed Description
Tree MATA MPL has been developed to provide pre-seasonal specific immunotherapy for patients with proven type I hypersensitivity to cross reacting tree pollens. MPL (Monophosphoryl Lipid A), a purifie...
Eligibility Criteria
Inclusion
- The subject must sign the study consent form prior to any screening procedures being performed.
- If the volunteer is female of childbearing potential, she must demonstrate a negative urine pregnancy test and agree to remain abstinent or use an effective method of birth control or use a hormonal contraceptive
- The subject must demonstrate a positive skin prick test to Birch, Hazel and Alder pollen allergen extract
- The subject must demonstrate a positive skin prick test to positive histamine control
- The subject must demonstrate a negative skin prick test to negative control
- The subject must demonstrate a specific IgE for Birch, Hazel and Alder as documented by a RAST (radioallergosorbent test), or equivalent test
- The subject must have clinically acceptable results from the screening procedure.
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 asthma or other lower respiratory tract condition
- 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, epithelia (cat, dog, and horse), grass mix
- Clinically relevant symptoms due to an IgE - mediated allergy at screening and before inclusion to the treatment period.
- Secondary alteration at the affected organ.
- History of auto-immune diseases or rheumatoid diseases
- Subject has a medical condition that prohibits the use of adrenalin
- Subject has disorder of tyrosine metabolism
- 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
- History of angioedema
- Subjects determined by the Investigator to have any medical condition that could jeopardize their health or prejudice the results
- History of hypersensitivity to the excipients of the study medication
- History of immunotherapy with tree allergen extracts
- Current therapy with ß-blockers
- Currently receiving anti-allergy medication or other drugs with 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 30 days
- Subject cannot communicate reliably with the Investigator or is deemed uncooperative or noncompliant
- Females who are pregnant, breastfeeding, or refuse to use a reliable method of birth control
- 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 :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00107705
Start Date
April 1 2005
End Date
May 1 2005
Last Update
June 17 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Allied Research International Inc.
Mississauga, Ontario, Canada, L4W 1N2