Biomarkers of Cockroach Sublingual Immunotherapy 2 (BioCSI-2)

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Perennial Allergic Rhinitis; Asthma

Treatments: Biological: Cockroach Sublingual Immunotherapy (SLIT) - Low Dose; Other: Placebo; Biological: Cockroach Sublingual Immunotherapy (SLIT) - High Dose

Study type: Interventional

Funder types: NIH

Identifiers

NCT01380327

DAIT ICAC-17

Details and patient eligibility

About

This trial is a follow-up study of the ICAC-12 Phase I/II trial (NCT00829985), and is designed to study biomarkers of the immune response to allergen immunotherapy and the safety of this therapy in a pediatric population.

Full description

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 National Institute of Allergy and Infectious Diseases (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, ICAC is conducting a clinical trial comparing two doses of glycerinated German cockroach (Blattella germanica) allergenic extract to placebo, administered under the tongue (sublingual).

Enrollment: 99 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

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: ii. a forced expiratory volume at one second (FEV1) greater than or equal to 80% predicted value 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 (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 cockroach allergenic extract or placebo

• Parent or legally authorized representative (LAR) of child is 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. requires 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 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 (either oral and/or topical route[s] of administration)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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99 participants in 3 patient groups, including a placebo group

Cockroach Sublingual Immunotherapy (SLIT) - Low Dose

Experimental group

Description:

Glycerinated German cockroach (Blatella germanica) allergen extract administered sublingually with a maximally tolerated dose of 420 microliters daily

Treatment:

Biological: Cockroach Sublingual Immunotherapy (SLIT) - Low Dose

Placebo

Placebo Comparator group

Description:

Placebo administered sublingually not to exceed the maximally tolerated dose of either 1.) 420 microliters daily (placebo - low dose randomization) or 2.) 840 microliters twice daily (placebo - high dose randomization)

Treatment:

Other: Placebo

Cockroach Sublingual Immunotherapy (SLIT) - High Dose

Experimental group

Description:

Glycerinated German cockroach (Blatella germanica) allergen extract administered sublingually with a maximally tolerated dose of 840 microliters taken twice daily

Treatment:

Biological: Cockroach Sublingual Immunotherapy (SLIT) - High Dose