Ignite Creation Date:
2024-05-05 @ 11:28 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01337336
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2011-04-15
Brief Title:
Chronic Obstructive Pulmonary Disease COPD-Related Outcomes and Costs for Patients on Combination Fluticasone Propionate-Salmeterol Xinafoate 25050mcg Versus Anticholinergics in a COPD-Comorbid DepressionAnxiety Population
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Chronic Obstructive Pulmonary Disease COPD-Related Outcomes and Costs for Patients on Combination Fluticasone Propionate-Salmeterol Xinafoate 25050mcg Versus Anticholinergics in a Comorbid COPD-DepressionAnxiety Population
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:
The objective of this study was to examine COPD-related outcomes for patients with comorbid depressionanxiety who are on combination fluticasone propionatesalmeterol xinafoate compared to those receiving anticholinergics
The prevalence of comorbid depressionanxiety in patients with chronic obstructive pulmonary disease COPD is estimated to be high and range from 10-40 given that the risk of depressionanxiety symptoms is almost 3 times higher in patients with versus without COPD Additionally patients with comorbid COPD and depressionanxiety have higher COPD-related healthcare utilization and costs compared to those without depressionanxiety Therapy with maintenance medications for COPD has been recommended to prevent future adverse COPD outcomes but the impact of initiating these interventions has not yet been evaluated in a higher-risk population with comorbid COPD-depressionanxiety The present study compares the risk of COPD exacerbations and COPD-related costs in patients initiating maintenance medications for treatment of COPD in a comorbid COPDdepression-anxiety population Maintenance medications include inhaled corticosteroid ICS long-acting beta agonist LABA combination drug product of ICSLABA and anti-cholinergics AC including tiotropium TIO and ipratropium or combination ipratropium-albuterol collectively abbreviated as IPR
The prevalence of comorbid depressionanxiety in patients with chronic obstructive pulmonary disease COPD is estimated to be high and range from 10-40 given that the risk of depressionanxiety symptoms is almost 3 times higher in patients with versus without COPD Additionally patients with comorbid COPD and depressionanxiety have higher COPD-related healthcare utilization and costs compared to those without depressionanxiety Therapy with maintenance medications for COPD has been recommended to prevent future adverse COPD outcomes but the impact of initiating these interventions has not yet been evaluated in a higher-risk population with comorbid COPD-depressionanxiety The present study compares the risk of COPD exacerbations and COPD-related costs in patients initiating maintenance medications for treatment of COPD in a comorbid COPDdepression-anxiety population Maintenance medications include inhaled corticosteroid ICS long-acting beta agonist LABA combination drug product of ICSLABA and anti-cholinergics AC including tiotropium TIO and ipratropium or combination ipratropium-albuterol collectively abbreviated as IPR
Detailed Description:
This was a retrospective cohort study using a large administrative database study period 112003 through 6302009 Date of first FSC or ACs tiotropium ipratropium alone or in combination with albuterol was defined as the index date Managed care enrollees aged 40 years having at least one medical claim with a primary diagnosis of COPD ICD code 491xx 492xx and 496xx and a diagnosis of depression at least one claim with depressionanxiety or at least one prescription claim for depressionanxiety in one-year pre-index and within 60-days post-index were defined in the comorbid population Patients were continuously eligible throughout the one-year pre and post-index periods Negative binomial models were used to analyze number of COPD-related events hospitalization IP emergency department ED office visits with oral steroid andor antibiotic prescription within 5 days OVRx and logistic regression was used to examine risk of COPD events between the two cohorts COPD-related costs were compared between the two cohorts using - generalized linear model with log-linkgamma distribution after adjusting for baseline differences
Specifically the study hypothesis for the primary outcome being tested was
Ho There is no difference in risk of any COPD-related exacerbation between FSC and AC cohorts Ha There is a difference in risk of any COPD-related exacerbation between FSC and AC cohorts
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 cohorts Ha There is a difference in COPD-related costs between FSC and AC cohorts
Specifically the study hypothesis for the primary outcome being tested was
Ho There is no difference in risk of any COPD-related exacerbation between FSC and AC cohorts Ha There is a difference in risk of any COPD-related exacerbation between FSC and AC cohorts
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 cohorts Ha There is a difference in COPD-related costs between FSC and AC cohorts
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