CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 82 enrolled
Drug / intervention
German cockroach allergenic extract +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03541187
NCT03541187Phase 2Completed

Cockroach Immunotherapy in Children and Adolescents

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted May 30, 2018·Updated May 22, 2023

In Brief

A Phase 2 clinical trial evaluating German cockroach allergenic extract and Placebo for German cockroach allergenic extract for Persistent Asthma. Completed, enrolled 82 participants across 11 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMay 30, 2018
Enrollment StartJul 16, 2018
Primary CompletionJun 2, 2022
Study CompletionJun 3, 2022
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 8.1 years ago

Interventions

German cockroach allergenic extractbiological

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).

Placebo for German cockroach allergenic extractbiological

Commercially- labeled licensed product, sterile diluent for allergenic extract (50% glycerinated), sodium bicarbonate (0.091%) sodium chloride (0.166%).