Ignite Creation Date:
2024-05-05 @ 11:42 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01395875
Status:
COMPLETED
Last Update Posted:
2017-05-16
First Post:
2011-07-14
Brief Title:
Outcomes for Chronic Obstructive Pulmonary Disease Moderate Exacerbators Initiating Treatment
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Outcomes for Chronic Obstructive Pulmonary Disease Moderate Exacerbators Initiating Treatment
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:
Patients with moderate COPD as defined by GOLD guidelines constitute almost 46 to 54 of all diagnosed COPD patients Yet limited data exists on characterizing this study population in terms of drug therapy patterns and COPD-related resource use and costs The objective of the following study was to conduct an analysis in the real-world setting to 1 identify and characterize COPD patients with moderate exacerbations and 2 evaluate the impact of initiating different maintenance therapies in this population Maintenance therapy medications include inhaled corticosteroids ICS long-acting beta agonists LABAs combination of ICSLABA and anticholinergics ACs including tiotropium TIO and ipratropium or combination ipratropium-albuterol collectively referred to as ipratropium IPR
Detailed Description:
Data from January 1 2003 to March 31 2009 will be available and termed as the study period Patients with at least one moderate exacerbation defined as a physicianoutpatient visit with a primary diagnosis of COPD and having an oral corticosteroid OCS or antibiotic prescription ABX within 5 days of physicianoutpatient visit will be identified as the target population The date of the first moderate exacerbation will serve as the patients index date and will be identified during the identification period of January 1 2004 through February 28 2009 Furthermore this moderate exacerbation should be the first medical claim with a primary diagnosis of COPD to ensure that only patients with moderate exacerbations will be captured Subsequently patients will be categorized into study cohorts based on the first maintenance drug prescription index drug received during the 30-day period after the index date termed as the treatment assessment period Maintenance drugs considered include fluticasone-salmeterol 25050 mcg FSC or anticholinergics AC including tiotropium TIO and ipratropium or combination ipratropium-albuterol collectively referred to as ipratropium IPR Patients not receiving any maintenance medication or those receiving maintenance medications other than those considered during the treatment assessment period will be excluded
All outcomes will be assessed during a follow-up period that will vary in length between 1 day and 1 year for each patient The variable follow-up period will be defined as the period that starts on the day after the treatment assessment period and ends on the earliest of the following event dates the end of the study period March 31 2009 the end of the patients continuous eligibility in the health plan the end of the patients 1-year follow-up treatment switch date ie a switch to any study medication different from the index drug discontinuation date of the index drug ie more than a 60-day gap between the end of the days supply of the preceding prescription and the fill date of the next consecutive prescription or occurrence of any COPD-related exacerbation COPD-related hospitalization ED visit or physicianoutpatient visit with a prescription for an oral corticosteroid or antibiotic within 5 days of the visit
A 1-year period before the index date pre-period will be used to provide a baseline assessment of the study cohorts The specific dates for the pre- and follow-up periods will vary for each patient depending on their index date
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
All outcomes will be assessed during a follow-up period that will vary in length between 1 day and 1 year for each patient The variable follow-up period will be defined as the period that starts on the day after the treatment assessment period and ends on the earliest of the following event dates the end of the study period March 31 2009 the end of the patients continuous eligibility in the health plan the end of the patients 1-year follow-up treatment switch date ie a switch to any study medication different from the index drug discontinuation date of the index drug ie more than a 60-day gap between the end of the days supply of the preceding prescription and the fill date of the next consecutive prescription or occurrence of any COPD-related exacerbation COPD-related hospitalization ED visit or physicianoutpatient visit with a prescription for an oral corticosteroid or antibiotic within 5 days of the visit
A 1-year period before the index date pre-period will be used to provide a baseline assessment of the study cohorts The specific dates for the pre- and follow-up periods will vary for each patient depending on their index date
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