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Correlation Between IgE Parameters and the Response to Omalizumab in Subjects With Severe Asthma

NCT01002976 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2012-01-24

No results posted yet for this study

Summary

Omalizumab is an anti-IgE recombinant humanized monoclonal antibody.The efficacy and tolerability of omalizumab have been demonstrated in patients with moderate-to-severe and allergic (IgE-mediated) asthma. Clinical benefit with omalizumab is observed when serum free IgE levels are reduced to 50 ng/mL or less. However, although the causal role of IgE in allergic disease is well established, the relationship between free IgE and clinical symptoms of asthma has not been accurately quantified. Recent study demonstrated that omalizumab and free IgE concentrations are correlated with clinical outcomes. In non responder to omalizumab the clinical symptoms show random fluctuations around baseline without any tendency toward improvement despite adequate suppression of free IgE. In these patients it may be the ratio of specific IgE to total IgE or inter-patient variability in the expression of FceRI on effector cells that define whether the patient will respond or not to omalizumab.

This current study is designed to evaluate the mechanisms of responsiveness to omalizumab measuring the free IgE, specific IgE and the level of FceRI expression on the effector cell and the correlation to clinical response.

Conditions

  • Severe Allergic Asthma

Sponsors & Collaborators

  • Carmel Medical Center

    lead OTHER

Principal Investigators

  • Yochai Adir, MD · Carmel Medical Center

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-12-31
Completion
2012-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01002976 on ClinicalTrials.gov