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Clinical Trial Summary

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).


Clinical Trial 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. ;


Study Design

Observational Model: Case-Only, Time Perspective: Retrospective


Related Conditions & MeSH terms


NCT number NCT01397760
Study type Observational
Source Fiks, Iara Nely, M.D.
Contact
Status Not yet recruiting
Phase N/A
Start date August 2011
Completion date September 2011

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