Risk of Re-Hospitalization in Patients With Chronic Obstructive Pulmonary Disease (COPD) Post Exacerbation
19 mei 2017 bijgewerkt door: GlaxoSmithKline
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.
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
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Werkelijk)
1936
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
40 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
NVT
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Managed care patients (aged >40 years) who were FSC naive in the 12 months pre-index period.
The index-date was the date of discharge of the index COPD-related hospitalization/ED visit.
Eligible patients were required to newly initiate or switch to drug therapy with FSC or IPR/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.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
COPD patients receiving pharmacotherapy
COPD patients age 40 years and older receiving pharmacotherapy to treat their COPD and an index event of COPD hospitalization or ER visit.
|
fluticasone propionate / salmeterol xinofoate combination
Andere namen:
tiotropium alone, ipratropium alone, or in combination with albuterol
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Risk of Hospitalization in COPD patients
Tijdsspanne: January 1, 2003 through March 31, 2009 (up to 6 years)
|
Risk of hospitalization was assessed as any hospitalization that was catpured in the follow up period.
We required this event to have a primary discharge dx of COPD (ICD-9 code 491.xx, 492.xx, 496.xx) thus assuring it to be COPD-related.
a logistic regression model was run to examine this outcome.
|
January 1, 2003 through March 31, 2009 (up to 6 years)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of COPD exacerbations
Tijdsspanne: January 1, 2003 through March 31, 2009 (up to 6 years)
|
Exacerbation rates were assessed between the FSC and AC groups.
We examined COPD-related (primary dx of COPD (ICD-9 code 491.xx, 492.xx, 496.xx)) emergency department visits, outpatient visits, outpatient visits accompanied by prescription of oral steroids and antibiotics.
A negative binomial regression model was run to examine this outcome.
|
January 1, 2003 through March 31, 2009 (up to 6 years)
|
|
COPD-related Costs
Tijdsspanne: January 1, 2003 through March 31, 2009 (up to 6 years)
|
Mean COPD-related medical costs-, pharmacy costs - and total costs (the sum of medical and pharmacy costs) were calculated.
Medical costs included healthcare facility and professional services charges for hospital admissions, ED visits, physician and other outpatient visits, and laboratory, radiology and other outpatient procedures with a primary diagnosis of COPD.
Costs were adjusted to 2009 US dollars using the medical care component of the Consumer Price Index (CPI ).
A Generalized Linear Model (GLM) with a log-link function was used to assess differences in costs.
|
January 1, 2003 through March 31, 2009 (up to 6 years)
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 september 2010
Primaire voltooiing (Werkelijk)
1 oktober 2010
Studie voltooiing (Werkelijk)
1 maart 2011
Studieregistratiedata
Eerst ingediend
23 juni 2011
Eerst ingediend dat voldeed aan de QC-criteria
23 juni 2011
Eerst geplaatst (Schatting)
27 juni 2011
Updates van studierecords
Laatste update geplaatst (Werkelijk)
22 mei 2017
Laatste update ingediend die voldeed aan QC-criteria
19 mei 2017
Laatst geverifieerd
1 mei 2017
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 113899
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