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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Fiks, Iara Nely, M.D..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Fiks, Iara Nely, M.D.
ClinicalTrials.gov Identifier:
NCT01397760
First received: July 12, 2011
Last updated: July 19, 2011
Last verified: July 2011

July 12, 2011
July 19, 2011
August 2011
September 2011   (final data collection date for primary outcome measure)
Number of asthma hospitalization [ Time Frame: ONE YEAR Of Omalizumab USE ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01397760 on ClinicalTrials.gov Archive Site
Decrease the doses of oral steroids [ Time Frame: ONE YEAR Of Omalizumab USE ] [ Designated as safety issue: Yes ]
Same as current
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Not Provided
 
Retrospective Study for Description of The Use Of Omalizumab In Patients With Difficult To Control Asthma
Retrospective Study for Description of The Use Of Omalizumab In Patients With Difficult To Control Asthma

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.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
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Probability Sample

20 PATIENTS WITH difficult to treat asthma

Asthma
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
September 2011
September 2011   (final data collection date for primary outcome measure)

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)

Both
18 Years to 70 Years
No
Not Provided
Brazil
 
NCT01397760
iara fiks 1
No
IARA NELY FIKS
Fiks, Iara Nely, M.D.
Not Provided
Principal Investigator: iara n fiks, md pulmonary sao luiz hospital
Fiks, Iara Nely, M.D.
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP