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| Tracking Information | |
|---|---|
| First Received Date ICMJE | April 24, 2008 |
| Last Updated Date | April 25, 2008 |
| Start Date ICMJE | March 2003 |
| Primary Completion Date | May 2005 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
The primary endpoint is the number of nebulizations, scheduled and rescue, required to treat the patient. [ Time Frame: Daily for 14 days ] [ Designated as safety issue: Yes ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00667797 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current |
| Descriptive Information | |
| Brief Title ICMJE | Costs & Outcomes of Hospitalization/Treatment With Levalbuterol & Albuterol in Asthma or Chronic Obstructive Pulmonary Disease (COPD) Subjects |
| Official Title ICMJE | Pharmacoeconomic Outcomes of Levalbuterol and Racemic Albuterol in Inpatients Requiring Nebulization (POLARIS) |
| Brief Summary | An analysis of the costs and outcomes associated with hospitalization and treatment of Levalbuterol versus Racemic Albuterol in subjects with Asthma and COPD. |
| Detailed Description | This was a randomized, open-label study evaluating clinical and pharmacoeconomic outcomes in hospitalized patients with asthma or COPD who have been admitted due to an exacerbation of their disease and required further treatment with a beta2-adrenergic agonist. Approximately 430 patients were randomized and enrolled. Patients were then followed during their hospitalization. Once discharged, patient status was assessed via telephone interview 30 days after discharge. |
| Study Phase | Phase IV |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Health Services Research, Randomized, Open Label, Parallel Assignment |
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 486 |
| Completion Date | May 2005 |
| Primary Completion Date | May 2005 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00667797 |
| Responsible Party | Xopenex Medical Affairs Director, Sepracor |
| Study ID Numbers ICMJE | 051-921 |
| Study Sponsor ICMJE | Sepracor, Inc. |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | Sepracor, Inc. |
| Verification Date | April 2008 |
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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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