Subcutaneous Immunotherapy for Cockroach (SCITCO)

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: November 28, 2012
Last verified: November 2012
  Purpose

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 is to evaluate the efficacy of cockroach immunotherapy in inner city asthma. This trial is a pilot study of the safety of cockroach subcutaneous immunotherapy (SCIT) in adults who have a history of perennial allergic rhinitis, asthma, or both, and are cockroach sensitive.


Condition Intervention Phase
Asthma
Rhinitis, Allergic, Perennial
Biological: cockroach allergenic extract
Phase 1
Phase 2

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 adverse events and serious adverse events [ Time Frame: Each study visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in levels of German cockroach specific immunoglobulin E (IgE) observed after initiation of study treatment [ Time Frame: Baseline and monthly after maintenance dose reached ] [ Designated as safety issue: No ]
  • Changes in cockroach specific immunoglobulin G4 (IgG4), blocking antibodies; and other biomarkers [ Time Frame: Baseline and monthly after maintenance dose reached ] [ Designated as safety issue: No ]

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 Biological: 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.

  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 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 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 cockroach allergenic extract or placebo.
  • 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).
  • Cannot perform spirometry at screening.
  • Have an asthma severity classification at recruitment of severe persistent, using the he National Asthma Education and Prevention Program (NAEPP) classification, as evidenced by at least one of the following:

    • Require 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 (both oral and topical).
  Contacts and Locations
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

No publications provided

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
Last Updated: November 28, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Desensitization, Immunologic
Immunotherapy

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 April 16, 2014