Asthma, COPD
Conditions
Keywords
Asthma, COPD, chronic emphysema, chronic bronchitis
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. 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.
Interventions
DRUGlevalbuterol HCl
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.
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.
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the number of nebulizations, scheduled and rescue, required to treat the patient. | Daily for 14 days |
Secondary
| Measure | Time frame |
|---|---|
| Relapse Rate | Daily for 14 days |
| Clinical Chest Assessment | Daily for 14 days |
| Pulmonary Function Test Data (FEV1, FVC, PEF, FEV1/FVC) | Pre-dose each day and within 30 minutes after the initial dose of study medication on the first day |
| Disease Symptoms | Daily for 14 days |
| Investigator and Subject Global Assessments | Daily for 14 days |
| Discharge Location Classification | Daily for 14 days |
| Hospital Length of Stay | Daily for 14 days |
| Total Hospital Costs | Daily for 14 days |
| Cost of Respiratory Therapy Resources | Daily for 14 days |
| Respiratory Medication Costs | Daily for 14 days |
| Subject Satisfaction with Treatment | Daily for 14 days |
| Subject General Well-being | Daily and 30 days post discharge |
| Concomitant Respiratory Medication Use | Daily and 30 days post discharge |
Countries
United States
Outcome results
None listed