Risk of Re-Hospitalization in Patients With Chronic Obstructive Pulmonary Disease (COPD) Post Exacerbation
19 maggio 2017 aggiornato da: 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
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
1936
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
40 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
N/A
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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.
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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
Altri nomi:
tiotropium alone, ipratropium alone, or in combination with albuterol
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Risk of Hospitalization in COPD patients
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of COPD exacerbations
Lasso di tempo: 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
Lasso di tempo: 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)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 settembre 2010
Completamento primario (Effettivo)
1 ottobre 2010
Completamento dello studio (Effettivo)
1 marzo 2011
Date di iscrizione allo studio
Primo inviato
23 giugno 2011
Primo inviato che soddisfa i criteri di controllo qualità
23 giugno 2011
Primo Inserito (Stima)
27 giugno 2011
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
22 maggio 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
19 maggio 2017
Ultimo verificato
1 maggio 2017
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 113899
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