Impact of Omalizumab on Corticosteroid Use, Emergency Room Visits and Hospitalizations
This study is ongoing, but not recruiting participants.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01460862
First received: October 25, 2011
Last updated: NA
Last verified: October 2011
History: No changes posted
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 25, 2011 | ||||
| Last Updated Date | October 25, 2011 | ||||
| Start Date ICMJE | May 2011 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Frequency of emergency-department visits and hospitalizations [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Impact of Omalizumab on Corticosteroid Use, Emergency Room Visits and Hospitalizations | ||||
| Official Title ICMJE | Analyze the Impact of Omalizumab on Corticosteroid Use, Emergency Room Visits and Hospitalizations Among Patients With Uncontrolled Asthma Receiving High Dose Inhaled Corticosteroids | ||||
| Brief Summary | A retrospective database analysis to evaluate the impact of omalizumab on the use of corticosteroid, emergency-department visits and hospitalizations among patients with uncontrolled asthma and using high-dose Inhaled Corticosteroids (ICS) prior to initiating omalizumab. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with uncontrolled asthma and using high-dose ICS prior to initiating omalizumab. |
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| Condition ICMJE | Asthma | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Omalizumab Cohort | ||||
| 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 | Active, not recruiting | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Other protocol-defined inclusion/exclusion criteria may apply. |
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| Gender | Both | ||||
| Ages | 12 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01460862 | ||||
| Other Study ID Numbers ICMJE | HEORUS0091 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Novartis ( Novartis Pharmaceuticals ) | ||||
| Study Sponsor ICMJE | Novartis Pharmaceuticals | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Novartis | ||||
| Verification Date | October 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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