Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Utilization and Costs After Discharge From a Hospitalization or Emergency Department Visit on a Regimen of Fluticasone Propionate-Salmeterol Combination Versus Other Maintenance Therapies
This was a retrospective cross-sectional database study using administrative data (study
period: 1/1/2003 through 7/31/2008). Managed care enrollees (aged >40 years) having at least
one Hospitalization with primary or secondary diagnosis of COPD (ICD code 491.xx, 492.xx and
496.xx) or at least one Emergency Room (ER) visit with primary diagnosis of COPD (index
event) during the study period was the target population. All subjects were required to have
one year of pre-index period baseline data. COPD events of interest were ER, Hospital and
physician visits followed by oral corticosteroids (OCS) or antibiotics (Ab) within 7 days.
Other censoring events were treatment switch; loss of enrollment; >60-day gap between
medication fills; or end of study period.
This study is a non descriptive hypothesis testing study. Key study hypotheses are listed
below.
Specifically the study hypotheses for the primary outcome being tested were:
Ho: There is no difference in risk of COPD-related hospitalization between FSC and OMT Ha:
There is a difference in risk of COPD-related hospitalization between FSC and OMT
Hypothesis for the key secondary outcome of COPD-related costs that was tested was:
Ho: There is no difference in COPD-related costs between FSC and OMT Ha: There is a
difference in COPD-related costs between FSC and OMT
n/a
Observational Model: Cohort, Time Perspective: Retrospective
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