CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 31 enrolled
Drug / intervention
omalizumab +1 moredrug
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/NCT02388997
NCT02388997Phase 2Completed

An Evaluation of Treatment With Omalizumab to Improve the Asthmatic Response to an Experimental Infection With Rhinovirus

University of Virginia·interventional·Posted Mar 17, 2015·Updated Jul 9, 2018

In Brief

A Phase 2 clinical trial evaluating omalizumab and Rhinovirus (strain 16) for Asthma. Completed, enrolled 31 participants across 1 site.

Detailed Summary

Population surveys have shown a positive correlation between increased levels of total serum immunoglobulin E (IgE) and bronchial hyperreactivity. However, it is also clear that exacerbations of asthma are frequently triggered by viral respiratory tract infections, especially those caused by human rhinovirus (RV), also known as the "common cold" virus. This protocol explores the relationship between rhinovirus and allergen/IgE provoked inflammation. Experimental challenges with human (RV) result in more persistent upper respiratory tract symptom scores in asthmatics than in controls. Asthmatics with high levels of IgE also show greater sensitivity to methacholine and higher levels of expired nitric oxide (eNO) than those with low levels of IgE. These data suggest that patients with asthma and high levels of IgE are more likely to have pre-existing inflammation of the airways before virus challenge. This study is being done to determine whether anti-IgE therapy (with omalizumab) will lead to a significant decline in inflammatory biomarkers prior to virus inoculation, and thus reduce the severity of clinical manifestations after an experimental human RV challenge.

Study Details

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

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 17, 2015
Enrollment StartFeb 1, 2013
Primary CompletionMay 4, 2017
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 11.3 years ago

Interventions

omalizumabdrug

This medication has been approved for clinical use to treat patients with moderate to severe asthma by the FDA in 2003 and for use in this study (BB-IND# 10510)

Rhinovirus (strain 16)biological

This strain of pooled rhinovirus has been approved for use in experimental challenges (BB-IND# 15162) and for use in this study (BB-IND# 10510) by the FDA.