Retrospective Study for Description of The Use Of Omalizumab In Patients With Difficult To Control Asthma

Fiks, Iara Nely, M.D.20 enrolled

Overview

The purpose of this study is do describe the experience in the use of omalizumabe, in a real life scenario, in uncontrolled severe asthmatic patients attended in specialist outpatient clinics, and its efficacy and safety. The efficacy of omalizumab in the population observed will be evaluated as reduction of uncontrolled asthma related events, i.e. exacerbations, emergency dept. visits, hospitalization and asthma-related treatment (decrease of asthma medication).

Omalizumab is indicated in children over 6 years of age, with diagnosis of difficult to control asthma, presenting a component of atopy demonstrated preferably positive skin tests (prick test) or in vitro reactivity (rast) allergens common inhalants. Patients must also present the total serum IgE levels between 30 and 700UI/mL. Children until 12 years the IgE level is between 30 and 300 IU/ml.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Asthma

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: Patients on optimal asthma treatment, good compliance and no response to treatment according to asthma consensus (GINA/NAEEP and the Latinamerican Consensus for Difficult to treat Asthma)

Locations (1)

Iara Nely Fiks

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

Number of asthma hospitalization

Time frame: ONE YEAR Of Omalizumab USE

Secondary Outcomes

Decrease the doses of oral steroids

Time frame: ONE YEAR Of Omalizumab USE

Data from ClinicalTrials.gov

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