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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 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
  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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: IARA NELY FIKS
ClinicalTrials.gov Identifier: NCT01397760     History of Changes
Other Study ID Numbers: iara fiks 1
Study First Received: July 12, 2011
Last Updated: July 19, 2011
Health Authority: Brazil: National Committee of Ethics in Research

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014