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

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. Identifier: NCT01397760
Recruitment Status : Unknown
Verified July 2011 by Fiks, Iara Nely, M.D..
Recruitment status was:  Not yet recruiting
First Posted : July 20, 2011
Last Update Posted : July 20, 2011
Information provided by:
Fiks, Iara Nely, M.D.

Brief 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).

Condition or disease

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.

Study Type : Observational
Estimated Enrollment : 20 participants
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
Study Start Date : August 2011
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Omalizumab
U.S. FDA Resources

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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)

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 identifier (NCT number): 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

Responsible Party: IARA NELY FIKS Identifier: NCT01397760     History of Changes
Other Study ID Numbers: iara fiks 1
First Posted: July 20, 2011    Key Record Dates
Last Update Posted: July 20, 2011
Last Verified: July 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