AsthmaNCT00132847
Comparing Allergenic Effects of 3 German Cockroach Extracts in Adults
An observational study of Asthma and Allergy, run by National Institute of Allergy and Infectious Diseases (NIAID).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- German Cockroach Allergen extract
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to Oct 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
About this study
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.
Read the 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 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.
- Being tested
- German Cockroach Allergen extract
- Keywords
- Child, Adolescent, Urban Health
- Medical subject headings
- Asthma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
German Cockroach Allergen extractBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological potency of three commercially available German cockroach allergen extracts
measured in units of BAU/mL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2005 (estimated)
- Study startApr 2004
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Inner-City Asthma Consortium
- Responsible party
- Sponsor
- Investigators
- Peyton Eggleston, MD, Principal investigator, Johns Hopkins UniversityJacqueline Pongracic, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of ChicagoStan Szefler, MD, Principal investigator, National Jewish HealthFloyd Malveaux, MD, PhD, Principal investigator, Howard UniversityWilliam W. Busse, MD, Study director, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132847
- Sponsor's protocol ID
- DAIT ICAC-03
- Status last verified
- Jan 2013
- First submitted
- 8 Aug 2005
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Arruda LK, Ferriani VP, Vailes LD, Pomes A, Chapman MD. Cockroach allergens: environmental distribution and relationship to disease. Curr Allergy Asthma Rep. 2001 Sep;1(5):466-73. doi: 10.1007/s11882-001-0035-1.
PubMed 11892074Arruda LK, Vailes LD, Ferriani VP, Santos AB, Pomes A, Chapman MD. Cockroach allergens and asthma. J Allergy Clin Immunol. 2001 Mar;107(3):419-28. doi: 10.1067/mai.2001.112854.
PubMed 11240940Eggleston 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. doi: 10.1385/CRIAI:18:3:311. No abstract available.
PubMed 10981263Patterson ML, Slater JE. Characterization and comparison of commercially available German and American cockroach allergen extracts. Clin Exp Allergy. 2002 May;32(5):721-7. doi: 10.1046/j.1365-2222.2002.01397.x.
PubMed 11994096
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- German Cockroach Allergen Standardization Evaluation (CASE)
- ClinicalTrials.gov ID
- NCT00132847
- Acronym / sponsor ID
- DAIT ICAC-03
- Keywords
- Child, Adolescent, Urban Health
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Inner-City Asthma Consortium
- Study start
- Apr 2004
- Study completion
- Oct 2004
- First posted
- 22 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| German Cockroach Allergen extract | Biological | – |
Primary outcome
Biological potency of three commercially available German cockroach allergen extracts
measured in units of BAU/mL
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
- Background: PubMed 11892074Arruda LK, Ferriani VP, Vailes LD, Pomes A, Chapman MD. Cockroach allergens: environmental distribution and relationship to disease. Curr Allergy Asthma Rep. 2001 Sep;1(5):466-73. doi: 10.1007/s11882-001-0035-1.
- Background: PubMed 11240940Arruda LK, Vailes LD, Ferriani VP, Santos AB, Pomes A, Chapman MD. Cockroach allergens and asthma. J Allergy Clin Immunol. 2001 Mar;107(3):419-28. doi: 10.1067/mai.2001.112854.
- Background: PubMed 10981263Eggleston 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. doi: 10.1385/CRIAI:18:3:311. No abstract available.
- Background: PubMed 11994096Patterson ML, Slater JE. Characterization and comparison of commercially available German and American cockroach allergen extracts. Clin Exp Allergy. 2002 May;32(5):721-7. doi: 10.1046/j.1365-2222.2002.01397.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peyton Eggleston, MD principal investigator
Johns Hopkins University
Jacqueline Pongracic, MD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
Stan Szefler, MD principal investigator
National Jewish Health
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Allergy, run by National Institute of Allergy and Infectious Diseases (NIAID).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological potency of three commercially available German cockroach allergen extracts. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00132847, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2013.