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

GlaxoSmithKline (GSK)

Status

Completed

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Drug: fluticasone propionate/salmeterol xinafoate combination

Drug: Other maintenance Treatments (OMT)

Study type

Observational

Funder types

Industry

Identifiers

NCT01332461

112609

Details and patient eligibility

About

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

Enrollment

5,677 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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