NCT03541187

Cockroach Immunotherapy in Children and Adolescents

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Scientific evidence has shown that, over the past two decades, 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 Inner City Asthma Consortium (ICAC) is to evaluate the efficacy of cockroach immunotherapy in inner city asthma. The primary objective of the study is to determine if the response to nasal allergen challenge (NAC) will be changed with treatment with cockroach subcutaneous immunotherapy (SCIT) treatment.

Detailed description

This is a 1:1 randomized, double-masked (blind), placebo-controlled, multicenter trial with 2 treatment arms: * German Cockroach Subcutaneous Immunotherapy (SCIT) + guideline-based standard asthma care, OR * Placebo (for German Cockroach Subcutaneous Immunotherapy \[SCIT\]) + guideline-based standard asthma care Eighty participants 8 to 17 years of age who are sensitized to cockroach, have asthma, and a positive cockroach Nasal Allergen Challenge (NAC) before treatment randomization will be enrolled.

Conditions

• Persistent Asthma

Interventions

Type	Name	Description
BIOLOGICAL	German cockroach allergenic extract	Active ingredient: a non-standardized allergen derived from the extraction and purification of proteins from German cockroach (Blattella germanica). Non-standardized glycerinated German cockroach allergenic extract is approved in the United States for diagnostic skin testing and immunotherapy by subcutaneous injection (U.S. License 467).
BIOLOGICAL	Placebo for German cockroach allergenic extract	Commercially- labeled licensed product, sterile diluent for allergenic extract (50% glycerinated), sodium bicarbonate (0.091%) sodium chloride (0.166%).

Timeline

• Start date: 2018-07-16
• Primary completion: 2022-06-02
• Completion: 2022-06-03
• First posted: 2018-05-30
• Last updated: 2023-05-22
• Results posted: 2023-05-22

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study