Ignite Creation Date:
2024-05-05 @ 11:39 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01381458
Status:
COMPLETED
Last Update Posted:
2017-05-22
First Post:
2011-06-23
Brief Title:
Risk of Re-Hospitalization in Patients With Chronic Obstructive Pulmonary Disease COPD Post Exacerbation
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
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 25050mcg FSC Versus Anticholinergics ie Tiotropium TIO and Ipratropium or Combination Ipratropium-albuterol IPR Post-hospitalization or ED Visit for the Treatment of COPD
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 propionatesalmeterol xinafoate combination 25050 FSC versus anticholinergics ie 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
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
Detailed Description:
Managed care patients aged 40 years who were fluticasone propionatesalmeterol 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 hospitalizationEmergency 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 01012004 to 01312008 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 25050 versus anticholinergics TIO IP or IPR Examined risk of COPD-related exacerbations such as hospitalizations emergency department ED visits COPD-related physicianoutpatient visit with oral corticosteroid OCS or antibiotic prescription ABX within 5 days of physicianoutpatient visit and COPD-related medical pharmacy and total healthcare costs in follow-up period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None