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Development of Cockroach Immunotherapy by the Inner-City Asthma Consortium | Clinical Trials | Clareo Health

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Development of Cockroach Immunotherapy by the Inner-City Asthma Consortium

A Biomarker-Based Pilot Study of Cockroach Subcutaneous Immunotherapy in Cockroach Sensitive Adults With Asthma and/or Perennial Allergic Rhinitis (ICAC-18)

NCT01221285•National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

Summary

This trial is a biomarker-based pilot study of the safety of Cockroach Subcutaneous Immunotherapy in Cockroach-sensitive Adults (SCITCO) who have a history of perennial allergic rhinitis, asthma, or both.

Detailed Description

Scientific evidence has shown that, over the past two decades, the combination of cockroach allergy and cockroach exposure is one of the most important factors contributing to the dramatic increase in asthma morbidity seen in inner city children with asthma. Therefore, a major goal of the Inner City Asthma Consortium (ICAC) is to evaluate the efficacy of cockroach immunotherapy in inner city asthma.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Have a history of perennial allergic rhinitis, asthma, or both, for a minimum of 1 year before study entry. For those with asthma:
•* a diagnosis of asthma will be defined as a report by the participant that they have had a clinical diagnosis of asthma made by a physician over a year ago
•* the participant's asthma must be well controlled as defined by:
•* a forced expiratory volume at one second (FEV1) greater than or equal to 80% predicted value with or without controller medication
•* albuterol use for no more than 3 days per week in each of the previous 2 weeks for asthma symptoms (not including exercise prophylaxis)
•Are sensitive to German cockroach (Blattella germanica) as documented by a positive (\>= 3 mm greater than negative control) skin prick test result and detectable German cockroach specific IgE (\>=0.35 kUA/L)
•Have no known contraindications to therapy with glycerinated German (Blattella germanica) cockroach allergenic extract
•Are willing to sign the written Informed Consent prior to initiation of any study procedure

Exclusion Criteria

•Are pregnant or lactating. Females must be abstinent or use a medically acceptable birth control method throughout the study (e.g. oral, subcutaneous, mechanical, or surgical contraception)
•Are unable to perform spirometry at screening
•Have an asthma severity classification at recruitment of severe persistent, using the National Asthma Education and Prevention Program (NAEPP) classification, as evidenced by at least one of the following:
•* requires a dose of greater than 500 mcg of fluticasone per day or the equivalent of another inhaled corticosteroid
•* have received more than 2 courses of oral or parenteral corticosteroids within the last 12 months
•* have been treated with depot steroids within the last 12 months
•* have been hospitalized for asthma within the 6 months prior to recruitment
•* have had a life-threatening asthma exacerbation that required intubation, mechanical ventilation, or that resulted in a hypoxic seizure within 2 years prior to recruitment
•Do not have access to a phone (needed for scheduling appointments)
•Have received allergen immunotherapy (SLIT or SCIT) in the last 12 months prior to recruitment or who plan to initiate or resume allergen immunotherapy during the study. Subjects who only received placebo therapy in the BioCSI protocol (A Biomarker-based Pilot Study of Cockroach Sublingual Immunotherapy in Cockroach Sensitive Adults With Asthma and/or Perennial Allergic Rhinitis, ICAC-12, NCT00829985) are eligible to participate in this study
+8 more criteria

Locations (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Key Dates

Start Date

September 1, 2010

Primary Completion Date

October 1, 2011

Completion Date

October 1, 2011

Last Updated

June 11, 2014

Enrollment

ACTUAL participants

Conditions

AsthmaPerennial Allergic Rhinitis

Interventions

German cockroach (Blattella germanica) allergenic extract

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 11, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Development of Cockroach Immunotherapy by the Inner-City Asthma Consortium

Inclusion Criteria

Exclusion Criteria

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