NCT01380327

Biomarkers of Cockroach Sublingual Immunotherapy 2

A Biomarker-Based Pilot Study of Cockroach Sublingual Immunotherapy in Cockroach Sensitive Children With Asthma and/or Perennial Allergic Rhinitis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Asthma
• Perennial Allergic Rhinitis

Interventions

Type	Name	Description
BIOLOGICAL	Cockroach Sublingual Immunotherapy (SLIT) - Low Dose	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.
OTHER	Placebo	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.
BIOLOGICAL	Cockroach Sublingual Immunotherapy (SLIT) - High Dose	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.

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2011-06-27
• Last updated: 2014-06-11
• Results posted: 2014-05-30

Locations

5 sites across 1 country: United States