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
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Disease, Chronic Obstructive
Intervention: fluticasone propionate/salmeterol xinafoate combination (Drug); Other maintenance Treatments (OMT) (Drug)
Phase: N/A
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
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
Clinical Details
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
Study design: Observational Model: Cohort, Time Perspective: Retrospective
Primary outcome: Number of Participants Having a Hospitalization or Emergency Room (ER) Visit Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years
Secondary outcome: Number of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-yearsMean Monthly COPD-related Costs Per Participant
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- At least one hospitalization with a primary or secondary diagnosis of COPD or at
least one ER visit with a primary diagnosis of COPD
- Initiatiation (prescription) of FSC or non-FSC (i. e. TIO, ICS, LABA, IPR) during
peri-index period
- At least 40 years of age
- Continuous eligibility in the pre-index, peri-index, and follow-up periods
Exclusion Criteria
- Presence of exclusionary comorbid conditions during pre-index, peri-index, and
follow-up periods: respiratory cancer, cystic fibrosis, fibrosis due to TB, and
bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary tuberculosis,
sarcoidosis
- Controller medication use during peri-index period
- COPD-related hospitalization, ER visit, or physician visit plus OCS/Abx within 3 days
of visit during the peri-index period
Locations and Contacts
Additional Information
Related publications: Dalal AA, Shah M, D'Souza AO, Mapel DW. 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. Am J Manag Care. 2011 Mar 1;17(3):e55-65.
Starting date: November 2009
Last updated: August 4, 2011
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