Comparing Allergenic Effects of 3 German Cockroach Extracts in Adults
|First Received Date ICMJE||August 8, 2005|
|Last Updated Date||January 18, 2013|
|Start Date ICMJE||April 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Biological potency of three commercially available German cockroach allergen extracts
measured in units of BAU/mL
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00132847 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Comparing Allergenic Effects of 3 German Cockroach Extracts in Adults|
|Official Title ICMJE||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.
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 Administration (FDA) wants to standardize cockroach allergen vaccines for use in the U.S. Allergen standardization comprises two important components: the selection of a reference preparation of allergenic extract and the selection of procedures to compare manufactured products to the reference allergen extract.
Adults in this study will be exposed to different doses of each of 3 German cockroach allergen extracts via intradermal skin testing. Participants in this study will be adults who have a history of allergic disease or asthma and are sensitive to the German cockroach allergens being tested.
Participants will have 2 visits during this study: a screening session and a testing session. At screening, participants will be asked to complete a screening questionnaire and will undergo a targeted physical exam, vital signs measurement, and peak expiratory flow (PEF) testing. Premenopausal women will also have urine collected for pregnancy testing. At the screening session, a 15-minute prick/puncture test will be administered on the skin of the forearm with the proposed standard allergen extract, histamine (positive control), and diluent (negative control). Skin erythema (swelling) response to the injections will be recorded.
Some participants may continue into the testing session on the same day as the screening session; others will participate in the testing session at a second study visit within 4 weeks after study screening. At the start of the testing session, participants will be asked to complete a questionnaire about demographics, history of airway disease and previous skin testing, and current medication use. For participants whose testing session occurs on a different day than the screening session, vital signs measurement and PEF readings will occur and premenopausal women will have urine collected. Blood collection will occur prior to the skin test. Intradermal skin testing will consist of injections on the participant's back with multiple doses of 3 different extracts of German cockroach allergen. Each of the 3 extracts will require 4 to 7 injections, depending on the response to each dose. Erythema skin response to the dilutions will be recorded. Participants will be observed for at least 1 hour after the intradermal skin testing as a safety precaution. After the observation period, participants will undergo additional PEF testing and will be assessed for adverse reactions to the skin testing procedure. Participants may be given antihistamines to relieve itching.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||a group of adults who have a history of allergic disease or asthma and demonstrate sensitivity to the German cockroach allergen being tested|
|Intervention ICMJE||Biological: German Cockroach Allergen extract|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Terminated|
|Estimated Completion Date||October 2004|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 65 Years (Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Not Provided|
|Removed Location Countries|
|NCT Number ICMJE||NCT00132847|
|Other Study ID Numbers ICMJE||DAIT ICAC-03|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||National Institute of Allergy and Infectious Diseases (NIAID)|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Inner-City Asthma Consortium|
|Information Provided By||National Institute of Allergy and Infectious Diseases (NIAID)|
|Verification Date||January 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP