Biomarkers of Cockroach Sublingual Immunotherapy 2 (BioCSI-2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01380327
First received: June 22, 2011
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

Over the past two decades, scientific evidence has shown that 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 NIAID Inner City Asthma Consortium (ICAC) is ultimately to conduct a large multi-center trial of cockroach sublingual immunotherapy (SLIT) in inner-city asthma. As a step toward achieving this goal, the ICAC is conducting a clinical trial comparing two doses of glycerinated German cockroach allergenic extract to placebo, administered under the tongue (sublingual). This trial is designed to study biomarkers of the immune response to allergen immunotherapy and the safety of this therapy in a pediatric population.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Biomarker-Based Pilot Study of Cockroach Sublingual Immunotherapy in Cockroach Sensitive Children With Asthma and/or Perennial Allergic Rhinitis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Level of cockroach-specific IgE in the high-dose group measured after the initiation of treatment, adjusted for the baseline level. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Level of cockroach-specific IgE in the low-dose group [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change in cockroach specific IgG4, in the high-dose and the low-dose groups. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • The rate of adverse events and serious adverse events, including assessment of severity and treament relatedness [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 99
Study Start Date: May 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cockroach SLIT - Low Dose
420 micrograms once daily
Biological: Glycerinated German cockroach allergenic extract
nonstandardized glycerinated German cockroach allergenic extract used by sublingual administration
Other Name: Blattella germanica
Placebo Comparator: Placebo
uncolored 50% glycerinated saline and caramelized color matched 50% glycerinated saline
Experimental: Cockroach SLIT - High Dose
840 micrograms twice daily
Biological: Glycerinated German cockroach allergenic extract
nonstandardized glycerinated German cockroach allergenic extract used by sublingual administration
Other Name: Blattella germanica

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a history of perennial allergic rhinitis, asthma, or both, before study entry.
  • For those with asthma:

    1. 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.
    2. The participant's asthma must be well controlled as defined by: i. FEV1 greater than or equal to 80% predicted with or without controller medication; ii. 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 or peak flow 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:

    1. Require a dose of greater than 500 mcg of fluticasone per day or the equivalent of another inhaled corticosteroid.
    2. Have received more than 2 courses of oral or parenteral corticosteroids within the last 12 months.
    3. Have been treated with depot steroids within the last 12 months.
    4. Have been hospitalized for asthma within the 6 months prior to recruitment.
    5. 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 in the last 12 months prior to recruitment or who plan to initiate or resume allergen immunotherapy during the 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.
  • Have in the last 3 months prior to recruitment experienced on average >1 day per week any of the symptoms below:

    1. Nausea or vomiting
    2. Abdominal pain or cramps severe enough to interfere with daily activities (excluding those associated with menstruation).
    3. Diarrhea
  • Refuse to sign the Epinephrine Auto-injector Training Form. Participants who meet any of the following criteria are not eligible for enrollment and may not be reassessed.

Participants who meet any of the following criteria are not eligible for enrollment and may not be reassessed. Participants are ineligible if they:

  • 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
  • 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 patient e.g., gastrointestinal disease, gastroesophageal reflux disease, chronic infections, scleroderma, hepatic, and gallbladder disease.
  • 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: NCT01380327

Locations
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Ohio
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Investigators
Study Chair: Robert Wood, MD Johns Hopkins University
  More Information

Additional Information:
No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01380327     History of Changes
Other Study ID Numbers: DAIT ICAC-17
Study First Received: June 22, 2011
Last Updated: June 6, 2013
Health Authority: United States: Food and Drug Administration

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 17, 2014