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

Fiks, Iara Nely, M.D.

Status: Unknown

Conditions: Asthma

Study type: Observational

Identifiers

NCT01397760

iara fiks 1

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)