Risk of Re-Hospitalization in Patients With Chronic Obstructive Pulmonary Disease (COPD) Post Exacerbation
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: FSC (Drug); ACs (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 retrospective database study will assess differences in the risk of re-hospitalization
and other COPD-related exacerbations and costs for patients receiving fluticasone
propionate/salmeterol xinafoate combination 250/50 (FSC) versus anticholinergics [i. e.
tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (collectively referred
to as ipratropium - IPR)] post-hospitalization or Emergency Department (ED) visit for the
treatment of COPD.
This is a hypotheses testing study. Associations are compared between FSC and AC cohorts.
Hypotheses for the primary outcome and key secondary outcomes are presented 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 AC Ha:
There is a difference in risk of COPD-related hospitalization between FSC and AC
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 AC Ha: There is a
difference in COPD-related costs between FSC and AC
Clinical Details
Official title: Differences in the Risk of Re-hospitalization and Other COPD-related (Chronic Obstructive Pulmonary Disease) Exacerbations and Costs for Patients Receiving Fluticasone Propionate-salmeterol Xinafoate Combination 250/50mcg (FSC) Versus Anticholinergics [i.e. Tiotropium (TIO) and Ipratropium or Combination Ipratropium-albuterol (IPR) Post-hospitalization or ED Visit for the Treatment of COPD.
Study design: Observational Model: Cohort, Time Perspective: Retrospective
Primary outcome: Risk of Hospitalization in COPD patients
Secondary outcome: Number of COPD exacerbationsCOPD-related Costs
Detailed description:
Managed care patients (aged >40 years) who were fluticasone propionate/salmeterol xinafoate
combination (FSC)-naive in the 12 months pre-index period. The index-date was the date of
discharge of the index Chronic Obstructive Pulmonary Disease (COPD)-related
hospitalization/Emergency Department (ED) visit. Eligible patients were required to newly
initiate or switch to drug therapy with FSC or ipratropium (IPR) / tiotropium (TIO) during
the identification period (01/01/2004 to 01/31/2008) to treat COPD. Patients who switched to
another maintenance medication or had an exacerbation in the treatment assessment period
(30-days post-index date) were excluded from the study. Follow-up period was 12 months post
treatment assessment period. Patients classified as being on FSC 250/50 versus
anticholinergics (TIO, IP or IPR). Examined risk of COPD-related exacerbations such as
hospitalizations, emergency department (ED) visits, COPD-related physician/outpatient visit
with oral corticosteroid (OCS) or antibiotic prescription (ABX) within 5 days of
physician/outpatient visit and COPD-related medical, pharmacy, and total healthcare costs in
follow-up period.
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- ≥40 years of age at index discharge date
- Continuous health plan eligibility in the pre-index, treatment assessment, and
follow-up periods
- Absence of other fluticasone propionate -salmeterol xinafoate doses or combination
product of budesonide-formoterol anytime during pre-index, treatment assessment, and
follow-up periods
Exclusion Criteria:
- COPD-related exacerbation during the treatment assessment period
- Any therapy change, which was defined as switching or augmenting index therapy during
treatment assessment period
- Absence of comorbid conditions (respiratory cancer, cystic fibrosis, fibrosis due to
tuberculosis, bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary
tuberculosis, and sarcoidosis) during the pre-index, treatment assessment, and
follow-up periods
Locations and Contacts
Additional Information
Starting date: September 2010
Last updated: June 23, 2011
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