Development of Cockroach Immunotherapy by the Inner-City Asthma Consortium

This study has been completed.
Sponsor:
Collaborator:
Inner-City Asthma Consortium
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01221285
First received: October 13, 2010
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Asthma
Perennial Allergic Rhinitis
Biological: German cockroach (Blattella germanica) allergenic extract
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Biomarker-Based Pilot Study of Cockroach Subcutaneous Immunotherapy in Cockroach Sensitive Adults With Asthma and/or Perennial Allergic Rhinitis (ICAC-18)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Number of Reported Treatment-related Adverse Events (AEs) [ Time Frame: Baseline through 6-months of treatment ] [ Designated as safety issue: Yes ]
    Number of non-serious adverse events reported as possibly related, probably related, or definitely related to study participation.

  • Number of Reported Treatment-related Serious Adverse Events (SAEs) [ Time Frame: Baseline through 6-months of treatment ] [ Designated as safety issue: Yes ]
    Number of SAEs reported as possibly related, probably related, or definitely related to study participation.


Secondary Outcome Measures:
  • Change in German Cockroach-Specific Serum IgE Over Time [ Time Frame: Baseline through 6-months of treatment ] [ Designated as safety issue: No ]
    Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin E (IgE) vs. post-baseline German cockroach-specific serum IgE. Numerator is geometric mean post-baseline IgE; denominator is baseline IgE. This result is an indicator of immune modulation over time, however its clinical significance is unclear.

  • Change in German Cockroach-Specific Serum IgG Over Time [ Time Frame: Baseline through 6-months of treatment ] [ Designated as safety issue: No ]
    Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin G (IgG) vs. post-baseline German cockroach-specific serum IgG. Numerator is geometric mean post-baseline IgG; denominator is baseline IgG.This result is an indicator of immune modulation over time, however its clinical significance is unclear.

  • Change in German Cockroach-Specific Serum IgG4 Over Time [ Time Frame: Baseline through 6-months of treatment ] [ Designated as safety issue: No ]
    Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin subclass 4 (IgG4) vs. post-baseline German cockroach-specific serum IgG4. Numerator is geometric mean post-baseline IgG4; denominator is baseline IgG4. This result is an indicator of immune modulation over time, however its clinical significance is unclear.

  • Change in IgE Fragment Antibody Binding (FAB) Activity (10 Micrograms/mL Cockroach Allergen Extract) [ Time Frame: Baseline through 6-months of treatment ] [ Designated as safety issue: No ]
    Outcome is the change in mean IgE fragment antibody binding (FAB) activity, baseline to post-baseline. Serum from cockroach subcutaneous immunotherapy (SCIT)-treated participants were analyzed to determine if treatment inhibits the in-vitro cockroach antigen binding to B-cells after 6-months of treatment with cockroach SCIT, using the per protocol allergenic extract doses. This result is an indicator of immune modulation over time, however its clinical significance is unclear.


Enrollment: 11
Study Start Date: September 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: German cockroach allergenic extract
Participants will receive weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 mL of extract at a concentration of 1:20 wt/vol.
Biological: German cockroach (Blattella germanica) allergenic extract
Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 mL of extract at a concentration of 1:20 wt/vol.

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • Have previously been treated with anti-IgE therapy within 1 year of recruitment
  • Have received an investigational drug in the 30 days prior to recruitment or who plan to use an investigational drug during the study
  • Refuse to sign the Epinephrine Auto-injector Training Form
  • Do not primarily speak English
  • Plan to move from the area during the study period
  • Have a history of idiopathic anaphylaxis or anaphylaxis grade 2 or higher as defined in the protocol
  • Have unstable angina, significant arrhythmia, uncontrolled hypertension, history of autoimmune disease, or other chronic or immunological diseases that in the opinion of the investigator might interfere with the evaluation of the investigational agent or pose additional risk to the participant
  • Are using tricyclic antidepressants or beta-adrenergic blocker drugs (either oral or topical route[s] of administration)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221285

Locations
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Inner-City Asthma Consortium
Investigators
Study Chair: Robert Wood, MD Johns Hopkins University
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01221285     History of Changes
Other Study ID Numbers: DAIT ICAC-18, SCITCO
Study First Received: October 13, 2010
Results First Received: April 24, 2014
Last Updated: June 5, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Cockroach
Immunotherapy
Subcutaneous immunotherapy
Inner city asthma

Additional relevant MeSH terms:
Asthma
Rhinitis
Rhinitis, Allergic, Perennial
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on July 22, 2014