Retrospective Study for Description of The Use Of Omalizumab In Patients With Difficult To Control Asthma
| Tracking Information | |||||
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| First Received Date ICMJE | July 12, 2011 | ||||
| Last Updated Date | July 19, 2011 | ||||
| Start Date ICMJE | August 2011 | ||||
| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Number of asthma hospitalization [ Time Frame: ONE YEAR Of Omalizumab USE ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01397760 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Decrease the doses of oral steroids [ Time Frame: ONE YEAR Of Omalizumab USE ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Retrospective Study for Description of The Use Of Omalizumab In Patients With Difficult To Control Asthma | ||||
| Official Title ICMJE | Retrospective Study for Description of The Use Of Omalizumab In Patients With Difficult To Control Asthma | ||||
| 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). |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | 20 PATIENTS WITH difficult to treat asthma |
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| Condition ICMJE | Asthma | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | September 2011 | ||||
| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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) |
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01397760 | ||||
| Other Study ID Numbers ICMJE | iara fiks 1 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | IARA NELY FIKS | ||||
| Study Sponsor ICMJE | Fiks, Iara Nely, M.D. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Fiks, Iara Nely, M.D. | ||||
| Verification Date | July 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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