Development of Cockroach Immunotherapy by the Inner-City Asthma Consortium
Condition: Asthma; Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: German cockroach (Blattella germanica) allergenic extract
Intervention description: 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.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Cockroach; Immunotherapy; Subcutaneous immunotherapy; Inner city asthma

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.
    

Eligibility 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)