Cockroach Immunotherapy in Children and Adolescents
Condition: Persistent Asthma
MeSH terms: Asthma
Intervention: German cockroach allergenic extract; Placebo for German cockroach allergenic extract
Intervention description: Active ingredient: a non-standardized allergen derived from the extraction and purification of proteins from German cockroach (Blattella germanica). Non-standardized glycerinated German cockroach allergenic extract is approved in the United States for diagnostic skin testing and immunotherapy by subcutaneous injection (U.S. License 467).; Commercially- labeled licensed product, sterile diluent for allergenic extract (50% glycerinated), sodium bicarbonate (0.091%) sodium chloride (0.166%).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 82.0
Sex: All
Minimum age: 8 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: cockroach; immunotherapy; inner city asthma; subcutaneous immunotherapy (SCIT); Nasal Allergen Challenge (NAC)

Summary:

      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.

      The primary objective of the study is to determine if the response to nasal allergen
      challenge (NAC) will be changed with treatment with cockroach subcutaneous immunotherapy
      (SCIT) treatment.
    

Eligibility criteria:

        Inclusion Criteria:Subject(s)

          -  And/or parent guardian must be able to understand and provide informed consent;

          -  Age at date of recruitment (e.g., screening): 8 to 17 years of age

          -  Have a primary place of residence in one of the pre-selected recruitment census tracts
             (Reference: Inner-City Asthma Consortium):

             --Note: Subjects who do not live in the pre-selected census tracts but live within the
             Office of Management and Budget (OMB) defined Metropolitan Statistical Area and have
             publicly-funded health insurance will qualify for inclusion.

          -  Have a history of persistent asthma, for a minimum of 1 year before study entry:

               -  A diagnosis of asthma will be defined as a report by the caretaker that the
                  subject had a clinical diagnosis of asthma made by a clinician ≥1 year ago,
                  resulting in a prescription of preventative asthma medication, and

               -  Must have persistent asthma as defined by the current need for at least 88 mcg
                  fluticasone (or the equivalent of another inhaled corticosteroid) to control
                  asthma at the time of screening.

          -  At the time of randomization, the subject's asthma must be well controlled as defined
             by:

               -  A Forced Expiratory Volume in 1 second (FEV1) ≥80% predicted, and

               -  An Asthma Control Test (ACT) or Childhood Asthma Control Test (CACT) score ≥20.

          -  Is sensitive to German cockroach as documented by:

               -  a positive (≥3 mm greater than negative control) skin prick test result, and

               -  detectable German cockroach specific Immunoglobulin E (IgE) (≥ 0.35 kUA/L).

          -  Have no known contraindications to therapy with glycerinated German cockroach
             allergenic extract or placebo;

          -  Have a positive cockroach nasal challenge, as defined by reaching a Total Nasal
             Symptom Score (TNSS) of ≥6 or a sneezing score of 3 at dose 2 or above during the
             challenge before randomization; and

          -  Have documentation of current medical insurance with prescription coverage at
             randomization.

        Exclusion Criteria:Subject(s)

          -  Unable or unwilling to give written informed consent or comply with the study
             protocol;

          -  That is pregnant or lactating;

          -  That are post-menarcheal females must be abstinent or use a medically acceptable birth
             control method throughout their participation in the study (e.g. oral, subcutaneous,
             mechanical, or surgical contraception);

          -  That cannot perform spirometry and peak flow at treatment randomization;

          -  That have an asthma severity classification at the time of treatment randomization of
             severe persistent, using the The National Asthma Education and Prevention Program
             (NAEPP) classification, as evidenced by at least one of the following:

               -  Requires a dose >500 mcg of fluticasone per day or the equivalent of another
                  inhaled corticosteroid,

               -  Has received more than 2 courses of oral or parenteral corticosteroids in the
                  last 12 months or one course within the last 3 months prior to study entry,

               -  Has been treated with depot steroids within the 3 months prior to study entry,

               -  Has been hospitalized for asthma within the 6 months prior to study entry, or

               -  Has had a life-threatening asthma exacerbation that required intubation,
                  mechanical ventilation, or that resulted in a hypoxic seizure within 2 years
                  prior to study entry.

          -  Does not have access to a phone (needed for scheduling appointments);

          -  Has received allergen immunotherapy (Sublingual Immunotherapy [SLIT] or Subcutaneous
             Immunotherapy [SCIT]) in the last 12 months or, who plan to initiate or resume
             allergen immunotherapy during the study;

          -  Has received biologic therapy (e.g., anti-Immunoglobulin E [IgE], anti-IL-4,
             anti-IL-5) within 6 months of study entry;

          -  Has received an investigational drug in the 30 days prior to recruitment or who plan
             to use an investigational drug during the study;

          -  Has past or current medical problems or findings from physical examination or
             laboratory testing that are not listed above, which, in the opinion of the
             investigator, may:

               -  pose additional risks from participation in the study,

               -  may interfere with the subject's ability to comply with study requirements, or

               -  that may impact the quality or interpretation of the data obtained from the
                  study.

          -  Who have nasal polyps or other major structural abnormalities in their nasal cavities
             as assessed by anterior rhinoscopy,

          -  Who meet any of the following criteria are not eligible for enrollment and may not be
             reassessed:

               -  That plan to move from the area during the study period,

               -  Have a history of anaphylaxis grade 3 or higher as defined by World Allergy
                  Organization Subcutaneous Immunotherapy Systemic Reaction Grading System,

               -  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 product or pose additional risk to the subject,

               -  Past or current medical problems or findings from physical examination or
                  laboratory testing that are not listed above, which, in the opinion of the
                  investigator,

                    -  may pose additional risks from participation in the study,

                    -  may interfere with the subject's ability to comply with study requirements,

                    -  or that may impact the quality or interpretation of the data obtained from
                       the study.

               -  Are using tricyclic antidepressants or beta-adrenergic blocker drugs (both oral
                  and topical).