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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01397760
Enrollment
20
Registered
2011-07-20
Start date
2011-08-31
Completion date
2011-09-30
Last updated
2011-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

DIFFICULT TO CONTROL ASTHMA, OMALIZUMABE

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).

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.

Interventions

None listed

Sponsors

Fiks, Iara Nely, M.D.
Lead SponsorINDIV

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Number of asthma hospitalizationONE YEAR Of Omalizumab USE

Secondary

MeasureTime frame
Decrease the doses of oral steroidsONE YEAR Of Omalizumab USE

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026