Risk of Re-Hospitalization in Patients With Chronic Obstructive Pulmonary Disease (COPD) Post Exacerbation
19 maja 2017 zaktualizowane przez: 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
Przegląd badań
Status
Zakończony
Szczegółowy opis
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.
Typ studiów
Obserwacyjny
Zapisy (Rzeczywisty)
1936
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
40 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie dotyczy
Płeć kwalifikująca się do nauki
Wszystko
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
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.
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
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
Inne nazwy:
tiotropium alone, ipratropium alone, or in combination with albuterol
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Risk of Hospitalization in COPD patients
Ramy czasowe: 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)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Number of COPD exacerbations
Ramy czasowe: 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
Ramy czasowe: 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)
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 września 2010
Zakończenie podstawowe (Rzeczywisty)
1 października 2010
Ukończenie studiów (Rzeczywisty)
1 marca 2011
Daty rejestracji na studia
Pierwszy przesłany
23 czerwca 2011
Pierwszy przesłany, który spełnia kryteria kontroli jakości
23 czerwca 2011
Pierwszy wysłany (Oszacować)
27 czerwca 2011
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
22 maja 2017
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
19 maja 2017
Ostatnia weryfikacja
1 maja 2017
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 113899
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .