Asthma Clinical Trial
Official title:
mRNA Expression as a Biomarker of Xolair (Omalizumab) Response
Objectives: 1. Determine if mRNA expression could be use as a biomarker to predict and
monitor the response to omalizumab in patients with difficult control asthma 2. Identify
which genes are switched on and which are switched off by using Omalizumab.
Methods: This study is an open label clinical trial, with six patients. The patients will
receive Omalizumab according to their age and weight (maximum dose: 375 mg every 15 days)
for 4 months. There will be a run-in period of one month, when allergic asthma diagnosis
will be confirmed and treatment will be optimized. Patients will be evaluated and will have
blood sample collected on 3 occasions: in the beginning, 2 months after baseline and at the
end of the study. Blood samples will always be collected one week after the last omalizumab
dose. Primary outcome will be RNA expression of 20 genes measured by real time-PCR
(high-affinity IgE receptor, IL-4, IL-5, IL-13, gama-IFN, quimokines, Fc epsilon, between
others). Secondary outcomes will be ACT, ACQ and spirometry.
Study rational: There is not a biomarker that can predict which patients will respond to
Omalizumab and those who will not respond. Nowadays, the monitoring of therapeutic response
to Omalizumab is based on clinical and spirometric data.
On the other hand, when a medication is administered, it has its main expected effect, but
also acts on other targets with various direct and indirect effects. We do not know all the
genes that are switched on and those that are switched off by the use of Omalizumab. For
example, anti-IgE has been developed to block serum total IgE and thereby improve control of
allergic asthma. However, the studies noted that Omalizumab also reduces the receptors
FcepsilonRI, which may have implications for the treatment of autoimmune urticaria.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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