Trial Outcomes & Findings for Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Utilization and Costs After Discharge From a Hospitalization or Emergency Department Visit on a Regimen of Fluticasone Propionate-Salmeterol Combination Versus Other Maintenance Therapies (NCT NCT01332461)
NCT ID: NCT01332461
Last Updated: 2017-06-27
Results Overview
The number of participants (par.) with a COPD-related hospitalization/ ER visit was computed during follow-up (FU) and was standardized by dividing by the total days of FU in each cohort since par. had different lengths of FU. The number of par. per 100 person-years was computed as: numerator = total number of par. with a COPD-related hospitalization/ER visit; denominator = sum of the time of FU in years across all par./100. The index date is defined as the date of discharge from a hospitalization/ER visit for COPD that had a maintenance medication dispensed within 60 days post-discharge.
COMPLETED
5677 participants
Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)
2017-06-27
Participant Flow
Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and used to develop a patient cohort. All diagnoses and treatments are recorded in the course of routine medical practice.
Participant milestones
| Measure |
Fluticasone/Salmeterol Combination (FSC) Cohort
Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
|
Other Maintenance Therapies Cohort
Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
|
|---|---|---|
|
Overall Study
STARTED
|
1291
|
4386
|
|
Overall Study
COMPLETED
|
1291
|
4386
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Utilization and Costs After Discharge From a Hospitalization or Emergency Department Visit on a Regimen of Fluticasone Propionate-Salmeterol Combination Versus Other Maintenance Therapies
Baseline characteristics by cohort
| Measure |
Fluticasone/Salmeterol Combination (FSC) Cohort
n=1291 Participants
Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
|
Other Maintenance Therapies Cohort
n=4386 Participants
Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
|
Total
n=5677 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.1 Years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
68.5 Years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
68.2 Years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
698 Participants
n=5 Participants
|
2183 Participants
n=7 Participants
|
2881 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
593 Participants
n=5 Participants
|
2203 Participants
n=7 Participants
|
2796 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)Population: Managed care enrollees with at least 1 inpatient hospitalization (IP) with primary or secondary diagnosis of COPD (International Classification of Disease (ICD) code 491.xx, 492.xx, and 496.xx) or at least one ER visit with primary diagnosis of COPD during the study period with maintenance medication within 60 days post-discharge
The number of participants (par.) with a COPD-related hospitalization/ ER visit was computed during follow-up (FU) and was standardized by dividing by the total days of FU in each cohort since par. had different lengths of FU. The number of par. per 100 person-years was computed as: numerator = total number of par. with a COPD-related hospitalization/ER visit; denominator = sum of the time of FU in years across all par./100. The index date is defined as the date of discharge from a hospitalization/ER visit for COPD that had a maintenance medication dispensed within 60 days post-discharge.
Outcome measures
| Measure |
Fluticasone/Salmeterol Combination (FSC) Cohort
n=1291 Participants
Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
|
Other Maintenance Therapies Cohort
n=4386 Participants
Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
|
|---|---|---|
|
Number of Participants Having a Hospitalization or Emergency Room (ER) Visit Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years
|
8.6 participants per 100 person-years
|
16.3 participants per 100 person-years
|
SECONDARY outcome
Timeframe: Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)Population: Managed care enrollees with at least 1 inpatient hospitalization (IP) with primary or secondary diagnosis of COPD (International Classification of Disease (ICD) code 491.xx, 492.xx, and 496.xx) or at least one ER visit with primary diagnosis of COPD during the study period with maintenance medication within 60 days post-discharge
The number of participants having a COPD-related event was computed during the follow-up and was standardized by dividing by the total days of follow-up in each cohort since patients had different lengths of follow-up. Four types of COPD events were defined: COPD-related hospitalization, emergency room (ER) visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 3 days of the visit, or combined occurrence of any of the aforementioned three types.
Outcome measures
| Measure |
Fluticasone/Salmeterol Combination (FSC) Cohort
n=1291 Participants
Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
|
Other Maintenance Therapies Cohort
n=4386 Participants
Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
|
|---|---|---|
|
Number of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years
COPD-related hospitalization
|
2.8 participants per 100 person-years
|
6.0 participants per 100 person-years
|
|
Number of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years
COPD-related ER visit
|
6.6 participants per 100 person-years
|
12.0 participants per 100 person-years
|
|
Number of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years
COPD-related physician + Rx visit
|
27.2 participants per 100 person-years
|
37.4 participants per 100 person-years
|
|
Number of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years
COPD-related hospitalization/ER visit/physician+Rx
|
34.6 participants per 100 person-years
|
50.7 participants per 100 person-years
|
SECONDARY outcome
Timeframe: Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)Population: Managed care enrollees with at least 1 inpatient hospitalization (IP) with primary or secondary diagnosis of COPD (International Classification of Disease (ICD) code 491.xx, 492.xx, and 496.xx) or at least one ER visit with primary diagnosis of COPD during the study period with maintenance medication within 60 days post-discharge
Cost categories included medical, pharmacy, and total calculated as the sum of medical and pharmacy. Costs were computed during a variable follow-up period and were standardized on a per-month basis. COPD-related medical costs were computed using claims with a primary diagnosis of COPD, and COPD-related pharmacy costs were computed using the paid amounts of pharmacy claims for prescription medication used for COPD.
Outcome measures
| Measure |
Fluticasone/Salmeterol Combination (FSC) Cohort
n=1291 Participants
Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
|
Other Maintenance Therapies Cohort
n=4386 Participants
Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
|
|---|---|---|
|
Mean Monthly COPD-related Costs Per Participant
COPD-related total costs
|
205 United States (US) dollars
Standard Deviation 459.4
|
297 United States (US) dollars
Standard Deviation 1376.4
|
|
Mean Monthly COPD-related Costs Per Participant
COPD-related pharmacy costs
|
121 United States (US) dollars
Standard Deviation 121.8
|
126 United States (US) dollars
Standard Deviation 307.7
|
|
Mean Monthly COPD-related Costs Per Participant
COPD-related medical costs
|
84 United States (US) dollars
Standard Deviation 432.5
|
171 United States (US) dollars
Standard Deviation 1331.4
|
Adverse Events
Fluticasone/Salmeterol Combination (FSC) Cohort
Other Maintenance Therapies Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER