Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132847
Status:
TERMINATED
Last Update Posted:
2013-01-23
First Post:
2005-08-08
Brief Title:
Comparing Allergenic Effects of 3 German Cockroach Extracts in Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
German Cockroach Allergen Standardization Evaluation CASE
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 commercially available German cockroach allergy extracts can be compared using the ID50EAL method to standardize German cockroach allergens
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
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 Administration FDA wants to standardize cockroach allergen vaccines for use in the US 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 prickpuncture 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 participants 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
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 prickpuncture 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 participants 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None