Asthma Clinical Trial
Official title:
German Cockroach Allergen Standardization Evaluation (CASE)
The purpose of this study is to test and compare the allergenic effects of three
commercially available German cockroach allergen extracts in adults.
Study hypothesis: The biological potency of three commercially available German cockroach
allergy extracts can be compared using the ID50EAL method to standardize German cockroach
allergens.
Status | Terminated |
Enrollment | 4 |
Est. completion date | October 2004 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - In good general health - Speak English - Have valid prick/puncture skin test defined by sum of erythema to histamine base (1.0 mg/ml) of 35 mm or greater - Have intradermal skin test defined by sum of erythema to histamine base (0.275 mg/ml : 0.1 mg/ml base) of 35 mm or greater - Self-reported history of allergic disease, such as symptoms compatible with allergic rhinitis or asthma - Erythema diameter response of 30 mm or greater to a prick/puncture skin test with an undiluted preparation of one of the cockroach allergen extracts being tested - Available for the duration of the study Exclusion Criteria: - Skin coloring or condition that would complicate the measurement of erythema responses - Dermographism (development of hives following skin contact with an object) greater than a 4 mm erythema diameter response following saline skin test at screening - Current use of tricyclic antidepressants, MAO inhibitors, or beta-blockers - Current use of antihistamines - Use of topical steroids in the 14 days prior to study screening on the areas to be skin tested - Current use of oral or parenteral corticosteroids - Current use of inhaled steroids. More information on this criterion can be found in the protocol. - Unable to provide a contact name in case of an emergency - History of anaphylaxis - Have been to the emergency room for asthma within the last month prior to study entry - Hospitalization for asthma within the last 6 months prior to study entry - Cardiovascular disease. Participants who have had mitral valve prolapse or who have well-controlled hypertension are not excluded. - Pregnant or breastfeeding - Peak expiratory flow (PEF) of less than 75% predicted at screening or testing sessions - Past or present immunotherapy with the test allergen |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) | Inner-City Asthma Consortium |
Arruda LK, Ferriani VP, Vailes LD, Pomés A, Chapman MD. Cockroach allergens: environmental distribution and relationship to disease. Curr Allergy Asthma Rep. 2001 Sep;1(5):466-73. Review. — View Citation
Arruda LK, Vailes LD, Ferriani VP, Santos AB, Pomés A, Chapman MD. Cockroach allergens and asthma. J Allergy Clin Immunol. 2001 Mar;107(3):419-28. Review. — View Citation
Eggleston PA. Environmental causes of asthma in inner city children. The National Cooperative Inner City Asthma Study. Clin Rev Allergy Immunol. 2000 Jun;18(3):311-24. Review. — View Citation
Patterson ML, Slater JE. Characterization and comparison of commercially available German and American cockroach allergen extracts. Clin Exp Allergy. 2002 May;32(5):721-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Biological potency of three commercially available German cockroach allergen extracts | measured in units of BAU/mL | No |
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