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

This study is not yet open for participant recruitment.
Verified July 2011 by Fiks, Iara Nely, M.D.
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
History of Changes
  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:

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

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
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
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
 Immune System Diseases
Omalizumab
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 19, 2013