mRNA Expression as a Biomarker of Omalizumab Response

NCT01584687 | Unknown Phase 4 DMC

• 1 other identifier: CIGE025ABR03T
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Asthma

Keywords

asthma; difficult-to-control asthma; mRNA expression; biomarker; real time PCR; ACT; ACQ

Outcome Measures

Primary Outcomes (1)

• Change of mRNA expression in leukocytes (real time-PCR)

  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 30 genes measured by real time-PCR.

  At the end of the study (4months after baseline)

Secondary Outcomes (1)

• Change in the scores of questionnaires of asthma control

  At the end of the study (4 months after baseline)

Study Arms (1)

Omalizumab

EXPERIMENTAL

All patients will receive omalizumab.

Biological: Omalizumab

Interventions

Omalizumab BIOLOGICAL

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

Also known as: Anti-IgE, Xolair

Omalizumab

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• over 12 years
• severe asthma not controlled despite medication
• IgE between 70 and 1300 IU/ml and evidence of allergy clinical history and/or skin test or blood.

You may not qualify if:

• previous use of omalizumab
• smoke history

Sponsors & Collaborators

• Instituto de Investigação em Imunologia: lead

MeSH Terms

Conditions

Asthma

Interventions

Omalizumab; anti-IgE antibodies

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Pedro Giavina-Bianchi, MD,PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro Giavina-Bianchi, PhD,MD

CONTACT

(5511) 26616098; pbianchi@usp.br

Marcelo V Aun, MD

CONTACT

(5511) 26616225; marcelovivoloaun@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2012
• First Posted: April 25, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 25, 2012

Record last verified: 2012-04