Biomarkers of Cockroach Sublingual Immunotherapy 2
Condition: Asthma; Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      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.
    

Detailed 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).
    

Intervention name(s): Cockroach Sublingual Immunotherapy (SLIT) - Low Dose; Placebo; Cockroach Sublingual Immunotherapy (SLIT) - High Dose
Intervention type(s): Biological; Other; Biological
Intervention description(s): Participants are randomized to receive daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.; Participants are randomized to receive either daily (low dose) or twice-daily (high dose) placebo treatment placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.; Participants are randomized to receive twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
Other intervention name(s): Blattella germanica; German cockroach (Blattella germanica) placebo; Blattella germanica
Intervention MeSH terms: Immunomodulating Agents; Immunologic Factors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cockroach; immunotherapy; sublingual immunotherapy (SLIT); inner city asthma