AsthmaPhase 4POLARISNCT00667797
Costs & Outcomes of Hospitalization/Treatment With Levalbuterol & Albuterol in Asthma or Chronic Obstructive Pulmonary Disease (COPD) Subjects
A Phase 4 study testing levalbuterol HCl and albuterol Sulfate in people with Asthma and COPD, run by Sumitomo Pharma America, Inc. at 18 sites in United States.
Trial summary
An analysis of the costs and outcomes associated with hospitalization and treatment of Levalbuterol versus Racemic Albuterol in subjects with Asthma and COPD. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- levalbuterol HCl and albuterol Sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 486 participants
- Where
- 18 sitesUnited States
- Study dates
- Mar 2003to May 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects must be at least greater than or equal to 18 years of age at the time of consent.
- Subjects must have history of asthma or COPD for at least 6 months prior to hospitalization.
- Subjects must have been hospitalized due to an exacerbation of their disease and required further treatment with a nebulized beta2-adrenergic agonist.
- Subjects must have an oxygen saturation level greater than or equal to 90% with greater than or equal to 40% face mask supplemental oxygen.
Who cannot join
- Subjects who are likely to be in the Intensive Care Unit (ICU) or Critical Care Unit (CCU).
- Based upon history or physical exam in the ED or Clinic, subjects with known or suspected cause of pulmonary symptoms other than asthma or COPD, such as pneumonia, pulmonary embolism, cystic fibrosis, or angioedema. Subjects with CHF that are admitted with a primary admission diagnosis of COPD are not excluded.
- Female subjects who are pregnant or breast feeding.
- Subjects who have participated in an investigational drug study within 30 days of study entry or have previously participated in the current trial.
- Subjects who are planning to receive elective surgical procedures during the 30 day period after hospital discharge.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Study site
Birmingham, Alabama
Study site
Brandon, Florida
Study site
Chapel Hill, North Carolina
Study site
Chula Vista, California
Study site
Des Moines, Iowa
Study site
Great Neck, New York
Study site
Houston, Texas
Study site
Johnson City, New Jersey
Study site
Morgantown, West Virginia
Study site
Oakland, California
Study site
Pittsburgh, Pennsylvania
Study site
Portland, Oregon
Study site
San Antonio, Texas
Study site
Syracuse, New York
Study site
Washington D.C., District of Columbia
Study site
Waterbury, Connecticut
Study site
Wheat Ridge, Colorado
Study site
Winston-Salem, North Carolina
About this study
Official title: Pharmacoeconomic Outcomes of Levalbuterol and Racemic Albuterol in Inpatients Requiring Nebulization (POLARIS)
An analysis of the costs and outcomes associated with hospitalization and treatment of Levalbuterol versus Racemic Albuterol in subjects with Asthma and COPD.
Read the 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. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
- Being tested
- levalbuterol HCl, albuterol Sulfate
- Keywords
- Asthma, COPD, chronic emphysema, chronic bronchitis
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levalbuterol HClDrug
Also called Xopenex Inhalation Solution
Levalbuterol 1.25 mg will be prescribed every 6-8 hours, with standing orders for as needed PRN use. However, the prescribing physician may change the dose, frequency, and/or duration of levalbuterol administration at their discretion.
albuterol SulfateDrug
Also called Ventolin Inhalation Solution
Racemic albuterol 2.5 mg will be prescribed per the standard of care used in the institution, with standing orders for as needed PRN use. However, the prescribing physician may change the dose, frequency, and/or duration of racemic albuterol administration at their discretion.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | levalbuterol 1.25 mg Receives: Drug: levalbuterol HCl |
| 2 | Active comparator | Racemic albuterol 2.5 mg Receives: Drug: albuterol Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the number of nebulizations, scheduled and rescue, required to treat the patient.
Measured: Daily for 14 days
Secondary outcomes (13)
Hospital Length of Stay
Measured: Daily for 14 days
Relapse Rate
Measured: Daily for 14 days
Clinical Chest Assessment
Measured: Daily for 14 days
Pulmonary Function Test Data (FEV1, FVC, PEF, FEV1/FVC)
Measured: Pre-dose each day and within 30 minutes after the initial dose of study medication on the first day
Disease Symptoms
Measured: Daily for 14 days
Investigator and Subject Global Assessments
Measured: Daily for 14 days
Discharge Location Classification
Measured: Daily for 14 days
Concomitant Respiratory Medication Use
Measured: Daily and 30 days post discharge
Total Hospital Costs
Measured: Daily for 14 days
Cost of Respiratory Therapy Resources
Measured: Daily for 14 days
Respiratory Medication Costs
Measured: Daily for 14 days
Subject Satisfaction with Treatment
Measured: Daily for 14 days
Subject General Well-being
Measured: Daily and 30 days post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2008 (estimated)
- Study startMar 2003
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 486 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00667797
- Sponsor's protocol ID
- 051-921
- Acronym
- POLARIS
- Status last verified
- Feb 2012
- First submitted
- 24 Apr 2008
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacoeconomic Outcomes of Levalbuterol and Racemic Albuterol in Inpatients Requiring Nebulization (POLARIS)
- ClinicalTrials.gov ID
- NCT00667797
- Acronym / sponsor ID
- POLARIS / 051-921
- Keywords
- Asthma, COPD, chronic emphysema, chronic bronchitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 486 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 28 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: levalbuterol HCllevalbuterol 1.25 mg |
| 2 | Active comparator | Drug: albuterol SulfateRacemic albuterol 2.5 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects must be at least greater than or equal to 18 years of age at the time of consent.
- Subjects must have history of asthma or COPD for at least 6 months prior to hospitalization.
- Subjects must have been hospitalized due to an exacerbation of their disease and required further treatment with a nebulized beta2-adrenergic agonist.
- Subjects must have an oxygen saturation level greater than or equal to 90% with greater than or equal to 40% face mask supplemental oxygen.
Key exclusion criteria (5 listed)
- Subjects who are likely to be in the Intensive Care Unit (ICU) or Critical Care Unit (CCU).
- Based upon history or physical exam in the ED or Clinic, subjects with known or suspected cause of pulmonary symptoms other than asthma or COPD, such as pneumonia, pulmonary embolism, cystic fibrosis, or angioedema. Subjects with CHF that are admitted with a primary admission diagnosis of COPD are not excluded.
- Female subjects who are pregnant or breast feeding.
- Subjects who have participated in an investigational drug study within 30 days of study entry or have previously participated in the current trial.
- Subjects who are planning to receive elective surgical procedures during the 30 day period after hospital discharge.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levalbuterol HClAlso: Xopenex Inhalation SolutionLevalbuterol 1.25 mg will be prescribed every 6-8 hours, with standing orders for as needed PRN use. However, the prescribing physician may change the dose, frequency, and/or duration of levalbuterol administration at their discretion. | Drug | 1 |
| albuterol SulfateAlso: Ventolin Inhalation SolutionRacemic albuterol 2.5 mg will be prescribed per the standard of care used in the institution, with standing orders for as needed PRN use. However, the prescribing physician may change the dose, frequency, and/or duration of racemic albuterol administration at their discretion. | Drug | 2 |
Primary outcome
The primary endpoint is the number of nebulizations, scheduled and rescue, required to treat the patient.
Time frame: Daily for 14 days
13 secondary outcomes
Hospital Length of Stay
Time frame: Daily for 14 days
Relapse Rate
Time frame: Daily for 14 days
Clinical Chest Assessment
Time frame: Daily for 14 days
Pulmonary Function Test Data (FEV1, FVC, PEF, FEV1/FVC)
Time frame: Pre-dose each day and within 30 minutes after the initial dose of study medication on the first day
Disease Symptoms
Time frame: Daily for 14 days
Investigator and Subject Global Assessments
Time frame: Daily for 14 days
Discharge Location Classification
Time frame: Daily for 14 days
Concomitant Respiratory Medication Use
Time frame: Daily and 30 days post discharge
Total Hospital Costs
Time frame: Daily for 14 days
Cost of Respiratory Therapy Resources
Time frame: Daily for 14 days
Respiratory Medication Costs
Time frame: Daily for 14 days
Subject Satisfaction with Treatment
Time frame: Daily for 14 days
Subject General Well-being
Time frame: Daily and 30 days post discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing levalbuterol HCl and albuterol Sulfate in people with Asthma and COPD, run by Sumitomo Pharma America, Inc. at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the number of nebulizations, scheduled and rescue, required to treat the patient. (time frame: Daily for 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2012.