mRNA Expression as a Biomarker of Omalizumab Response

Sponsor
Instituto de Investigação em Imunologia
Study ID
NCT01584687
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — BIOLOGICAL
    The patients will receive Omalizumab according to their age and weight for 4 months.

Study Details

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.

Key Dates

Start date
Jun 30, 2012
Status verified
Apr 2012
Primary completion
Dec 31, 2012
Completion
Dec 31, 2012

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Omalizumab
    All patients will receive omalizumab.

Primary Outcome Measure

Change of mRNA expression in leukocytes (real time-PCR) [ Time Frame: At the end of the study (4months after baseline) ]

Central Contacts

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