Status:
TERMINATED
Comparing Allergenic Effects of 3 German Cockroach Extracts in Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Inner-City Asthma Consortium
Conditions:
Asthma
Allergy
Eligibility:
All Genders
18-65 years
Brief Summary
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...
Detailed Description
Cockroach allergens appear to be a major cause of inner city asthma. Because of the suspected relationship between domestic cockroach species and allergy and asthma symptoms, the Food and Drug Adminis...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2004
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00132847
Start Date
April 1 2004
End Date
October 1 2004
Last Update
January 23 2013
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