CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 54 enrolled
Drug / intervention
Glycerinated 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/NCT00829985
NCT00829985Phase 2Completed

A Biomarker-based Pilot Study of Cockroach Sublingual Immunotherapy in Cockroach Sensitive Adults With Asthma and/or Perennial Allergic Rhinitis (ICAC-12)

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jan 27, 2009·Updated Mar 21, 2017

In Brief

A Phase 2 clinical trial evaluating Glycerinated German Cockroach Allergenic Extract and Placebo for Rhinitis, Allergic, Perennial and Asthma. Completed, enrolled 54 participants across 4 sites.

Detailed Summary

There is currently no effective way to prevent development of allergic rhinitis (nasal allergies) and asthma and no cure. Sublingual immunotherapy (SLIT), a type of therapy in which allergens are placed under the tongue, may be a way to control and possibly prevent allergic rhinitis and asthma. However, detailed research of this approach is limited. The purpose of this study is to evaluate the safety and efficacy of a sublingual cockroach extract given to adults with perennial allergic rhinitis, asthma, or both.

Study Details

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

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 27, 2009
Enrollment StartJan 1, 2009
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 17.4 years ago

Interventions

Glycerinated German Cockroach Allergenic Extractbiological

Concentrated (1:20 w/v) daily doses of glycerinated German cockroach allergenic extract placed under the tongue to dissolve. The extract is also administered during the preliminary dosing visits in up to five escalating doses or until the maximum study dose (420 microliters, 1:20 w/v) is achieved.

Placebobiological

Daily doses of cockroach allergenic extract placebo placed under the tongue to dissolve