drugset / Trial / NCT03541187

Cockroach Immunotherapy in Children and Adolescents

NCT03541187 ↗

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2018-07-16
Primary completion
2022-06-02
Completion
2022-06-03

Outcome

Missed primary endpoint

registry analysis (superiority test); Cockroach SCIT vs Placebo; p = 0.63; Least Square Mean Difference -0.23 (95% CI -1.15 to 0.70); ANCOVA NCT03541187 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Glycerinated German Cockroach Allergenic Extract Unknown — Subcutaneous

Indications