Sublingual Cockroach Safety in Adults With Cockroach Allergy & Perennial Allergic Rhinitis With or Without Asthma
Condition: Allergy; Asthma
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Hypersensitivity
Intervention: Glycerinated German cockroach allergenic extract; Placebo
Intervention description: Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters [mL], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose [0.42 mL, 1:10 wt/vol] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route.; Placebo was administered only as the first dose (e.g., representing no Glycerinated German Cockroach bioequivalent allergy units) during the initial 1-day, 8-dose escalation, otherwise referred to as the Preliminary Dosing Visit. Refer to the Glycerinated German cockroach allergenic extract treatment for more details. Route of administration: sublingual-oral route.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 5 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Perennial Allergic Rhinitis; Asthma; Sublingual Immunotherapy (SLIT)

Summary:

      Immunotherapy may help reduce symptoms of allergy and asthma. Problems concerning compliance
      and adverse events with subcutaneous allergen immunotherapy have generated interest in
      delivering immunotherapy sublingually (under the tongue). The purpose of this study is to
      evaluate the safety of a cockroach extract given sublingually to people with perennial
      (year-round) allergic rhinitis, with or without asthma.
    

Eligibility criteria:

        Inclusion Criteria for All Participants:

          -  History of perennial allergic rhinitis with or without asthma for a minimum of 1 year
             prior to study entry

          -  Positive skin prick test to German cockroach performed along with negative (saline)
             and positive (histamine) controls

          -  Willing to sign EpiPen training form

          -  Parent or guardian willing to provide informed consent, if applicable

        Inclusion Criteria for Participants with Asthma:

          -  Diagnosis of well-controlled, mild to moderate persistent asthma, defined as having
             symptoms at least 3 times a week with no controller medication OR less than 3 times a
             week on controller medication. More information about this criterion can be found in
             the protocol.

          -  Diagnosis of asthma made over 1 year prior to study entry

        Exclusion Criteria:

          -  Have severe, persistent asthma (according to National Asthma Education and Prevention
             Program [NAEPP] classification) as evidenced by those who require a dose of greater
             than 500 mcg of fluticasone/day or equivalent of another inhaled corticosteroid OR who
             have been hospitalized for asthma within 6 months prior to study entry

          -  Life-threatening asthma exacerbation requiring intubation or mechanical ventilation or
             resulting in a hypoxic seizure in the 2 years prior to study entry

          -  History of anaphylaxis of Grade 2 or higher as defined in the protocol

          -  Unstable angina, significant arrhythmia, uncontrolled hypertension, or other chronic
             or immunologic diseases that, in the opinion of the investigator, may interfere with
             the study or pose additional risk to the patient. More information about this
             criterion can be found in the protocol.

          -  Taking medications that could induce gastrointestinal reactions during the study.
             Participants taking such medications must prove to be stable with no side effects for
             at least 3 months prior to study screening to be considered eligible.

          -  Received an investigational drug in the 30 days prior to study entry OR plan to
             receive an investigational drug during the study

          -  Received allergen immunotherapy in the 180 days prior to screening or plan to initiate
             or resume allergen immunotherapy during the study

          -  Taking tricyclic antidepressants or beta-adrenergic blocker drugs

          -  Received omalizumab in the 3 months prior to study screening

          -  Known contraindication to therapy with cockroach extract used in this study

          -  Mental illness that would interfere with the participant's ability to comply to study
             requirements

          -  History of drug or alcohol abuse that, in the opinion of the investigator, would
             interfere with the study

          -  Plan to leave study area during the study

          -  Does not primarily speak English, including caretakers of participants when the
             participant is a child

          -  Cannot perform spirometry

          -  Pregnant or breastfeeding