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NCT01397760 Clinical Trial

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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01397760
Other study ID # iara fiks 1
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 12, 2011
Last updated July 19, 2011
Start date August 2011
Est. completion date September 2011

Study information
Verified date July 2011
Source Fiks, Iara Nely, M.D.
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Observational

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).

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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)

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Brazil Iara Nely Fiks Sao Paulo

Sponsors (1)
Lead Sponsor Collaborator
Fiks, Iara Nely, M.D.

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of asthma hospitalization ONE YEAR Of Omalizumab USE Yes
Secondary Decrease the doses of oral steroids ONE YEAR Of Omalizumab USE Yes
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