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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by Fiks, Iara Nely, M.D..
Recruitment status was:  Not yet recruiting
Information provided by:
Fiks, Iara Nely, M.D. Identifier:
First received: July 12, 2011
Last updated: July 19, 2011
Last verified: July 2011
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).


Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Study for Description of The Use Of Omalizumab In Patients With Difficult To Control Asthma

Resource links provided by NLM:

Further study details as provided by Fiks, Iara Nely, M.D.:

Primary Outcome Measures:
  • Number of asthma hospitalization [ Time Frame: ONE YEAR Of Omalizumab USE ]

Secondary Outcome Measures:
  • Decrease the doses of oral steroids [ Time Frame: ONE YEAR Of Omalizumab USE ]

Estimated Enrollment: 20
Study Start Date: August 2011
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Detailed 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.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
20 PATIENTS WITH difficult to treat asthma

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)

  Contacts and Locations
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Please refer to this study by its identifier: NCT01397760

Iara Nely Fiks Not yet recruiting
Sao Paulo, Brazil, 04508011
Contact: IARA N FIKS, MD    55 11 38453800    IFIKS@UOL.COM.BR   
Sponsors and Collaborators
Fiks, Iara Nely, M.D.
Principal Investigator: iara n fiks, md pulmonary sao luiz hospital
  More Information

Responsible Party: IARA NELY FIKS Identifier: NCT01397760     History of Changes
Other Study ID Numbers: iara fiks 1
Study First Received: July 12, 2011
Last Updated: July 19, 2011

Keywords provided by Fiks, Iara Nely, M.D.:

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents processed this record on August 17, 2017