Risk of Re-Hospitalization in Patients With Chronic Obstructive Pulmonary Disease (COPD) Post Exacerbation
|ClinicalTrials.gov Identifier: NCT01381458|
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : May 22, 2017
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
|Condition or disease||Intervention/treatment|
|Pulmonary Disease, Chronic Obstructive||Drug: FSC Drug: ACs|
|Study Type :||Observational|
|Actual Enrollment :||1936 participants|
|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 Start Date :||September 2010|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||March 2011|
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
Other Name: Advair (tm)Drug: ACs
tiotropium alone, ipratropium alone, or in combination with albuterol
- Risk of Hospitalization in COPD patients [ Time Frame: 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.
- Number of COPD exacerbations [ Time Frame: 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.
- COPD-related Costs [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01381458
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|