Biomarkers of Cockroach Sublingual Immunotherapy 2

Phase 1/2 Completed 99 enrolled National Institute of Allergy and Infectious Diseases (NIAID)

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2011-05
Primary completion: 2012-06
Completion: 2012-06

Outcome

Met primary endpoint

registry Cockroach Sublingual Immunotherapy (SLIT) - High Dose vs Placebo; p = 0.001; Risk Ratio (RR) 1.7 (95% CI 1.2 to 2.3) NCT01380327 ↗

registry Cockroach Sublingual Immunotherapy (SLIT) - Low Dose vs Placebo; p <0.0001; Risk Ratio (RR) 2.3 (95% CI 1.7 to 3.1) NCT01380327 ↗

Publications

Results Wood RA, Togias A, Wildfire J, Visness CM, Matsui EC, Gruchalla R, Hershey G, Liu AH, O'Connor GT, Pongracic JA, Zoratti E, Little F, Granada M, Kennedy S, Durham SR, Shamji MH, Busse WW. Development of cockroach immunotherapy by the Inner-City Asthma Consortium. J Allergy Clin Immunol. 2014 Mar;133(3):846-52.e6. doi: 10.1016/j.jaci.2013.08.047. Epub 2013 Nov 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	glycerinated German cockroach (Blattella germanica) allergenic extract	Protein / enzyme biologic	420 ml	Other
Subject	glycerinated German cockroach (Blattella germanica) allergenic extract	Protein / enzyme biologic	840 ml	Other