Comparing Allergenic Effects of 3 German Cockroach Extracts in Adults

NCT00132847 | Terminated DMC

• 1 other identifier: DAIT ICAC-03
• Study Type: observational
• Target: 4
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma; Allergy

Keywords

Child; Adolescent; Urban Health

Outcome Measures

Primary Outcomes (1)

• Biological potency of three commercially available German cockroach allergen extracts

  measured in units of BAU/mL

Interventions

German Cockroach Allergen extract BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Inner-City Asthma Consortium: collaborator

Related Publications (4)

• 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.

  PMID: 11892074 BACKGROUND

• Arruda 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.

  PMID: 11240940 BACKGROUND

• 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. doi: 10.1385/CRIAI:18:3:311. No abstract available.

  PMID: 10981263 BACKGROUND

• 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. doi: 10.1046/j.1365-2222.2002.01397.x.

  PMID: 11994096 BACKGROUND

MeSH Terms

Conditions

Asthma; Hypersensitivity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Peyton Eggleston, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Jacqueline Pongracic, MD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

• Stan Szefler, MD

  National Jewish Health

  PRINCIPAL INVESTIGATOR

• Floyd Malveaux, MD, PhD

  Howard University

  PRINCIPAL INVESTIGATOR

• William W. Busse, MD

  University of Wisconsin, Madison

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2005
• First Posted: August 22, 2005
• Study Start: April 1, 2004
• Study Completion: October 1, 2004
• Last Updated: January 23, 2013

Record last verified: 2013-01