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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01397760
First Posted: July 20, 2011
Last Update Posted: July 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Fiks, Iara Nely, M.D.
  Purpose
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).

Condition
Asthma

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.
  Eligibility

Information from the National Library of Medicine

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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
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)

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01397760


Locations
Brazil
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.
Investigators
Principal Investigator: iara n fiks, md pulmonary sao luiz hospital
  More Information

Responsible Party: IARA NELY FIKS
ClinicalTrials.gov Identifier: NCT01397760     History of Changes
Other Study ID Numbers: iara fiks 1
First Submitted: July 12, 2011
First Posted: July 20, 2011
Last Update Posted: July 20, 2011
Last Verified: July 2011

Keywords provided by Fiks, Iara Nely, M.D.:
DIFFICULT TO CONTROL ASTHMA
OMALIZUMABE

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents