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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01332461
Enrollment
5677
Registered
2011-04-11
Start date
2009-11-30
Completion date
2010-05-31
Last updated
2017-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Brief summary

This was a retrospective cross-sectional database study using administrative data (study period: 1/1/2003 through 7/31/2008). Managed care enrollees (aged \>40 years) having at least one Hospitalization with primary or secondary diagnosis of COPD (ICD code 491.xx, 492.xx and 496.xx) or at least one Emergency Room (ER) visit with primary diagnosis of COPD (index event) during the study period was the target population. All subjects were required to have one year of pre-index period baseline data. COPD events of interest were ER, Hospital and physician visits followed by oral corticosteroids (OCS) or antibiotics (Ab) within 7 days. Other censoring events were treatment switch; loss of enrollment; \>60-day gap between medication fills; or end of study period. This study is a non descriptive hypothesis testing study. Key study hypotheses are listed 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 OMT Ha: There is a difference in risk of COPD-related hospitalization between FSC and OMT 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 OMT Ha: There is a difference in COPD-related costs between FSC and OMT

Interventions

Patients filling a prescription for fluticasone/salmeterol combination as index drug

DRUGOther maintenance Treatments (OMT)

OMT group includes tiotropium, ipratropium alone or in combination with albuterol, inhaled steroids, long acting beta agonists

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* At least one hospitalization with a primary or secondary diagnosis of COPD or at least one ER visit with a primary diagnosis of COPD * Initiatiation (prescription) of FSC or non-FSC (i.e. TIO, ICS, LABA, IPR) during peri-index period * At least 40 years of age * Continuous eligibility in the pre-index, peri-index, and follow-up periods

Exclusion criteria

* Presence of exclusionary comorbid conditions during pre-index, peri-index, and follow-up periods: respiratory cancer, cystic fibrosis, fibrosis due to TB, and bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary tuberculosis, sarcoidosis * Controller medication use during peri-index period * COPD-related hospitalization, ER visit, or physician visit plus OCS/Abx within 3 days of visit during the peri-index period

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Having a Hospitalization or Emergency Room (ER) Visit Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-yearsMaximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)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.

Secondary

MeasureTime frameDescription
Number of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-yearsMaximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)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.
Mean Monthly COPD-related Costs Per ParticipantMaximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)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.

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
Fluticasone/Salmeterol Combination (FSC) Cohort
Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
1,291
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.
4,386
Total5,677

Baseline characteristics

CharacteristicFluticasone/Salmeterol Combination (FSC) CohortOther Maintenance Therapies CohortTotal
Age, Continuous67.1 Years
STANDARD_DEVIATION 12.1
68.5 Years
STANDARD_DEVIATION 12.1
68.2 Years
STANDARD_DEVIATION 12.1
Sex: Female, Male
Female
698 Participants2183 Participants2881 Participants
Sex: Female, Male
Male
593 Participants2203 Participants2796 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Number of Participants Having a Hospitalization or Emergency Room (ER) Visit Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years

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.

Time frame: 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

ArmMeasureValue (NUMBER)
Fluticasone/Salmeterol Combination (FSC) CohortNumber of Participants Having a Hospitalization or Emergency Room (ER) Visit Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years8.6 participants per 100 person-years
Other Maintenance Therapies CohortNumber of Participants Having a Hospitalization or Emergency Room (ER) Visit Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years16.3 participants per 100 person-years
p-value: 0.0595% CI: [0.455, 0.926]Log Rank
Secondary

Mean Monthly COPD-related Costs Per Participant

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.

Time frame: 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

ArmMeasureGroupValue (MEAN)Dispersion
Fluticasone/Salmeterol Combination (FSC) CohortMean Monthly COPD-related Costs Per ParticipantCOPD-related total costs205 United States (US) dollarsStandard Deviation 459.4
Fluticasone/Salmeterol Combination (FSC) CohortMean Monthly COPD-related Costs Per ParticipantCOPD-related pharmacy costs121 United States (US) dollarsStandard Deviation 121.8
Fluticasone/Salmeterol Combination (FSC) CohortMean Monthly COPD-related Costs Per ParticipantCOPD-related medical costs84 United States (US) dollarsStandard Deviation 432.5
Other Maintenance Therapies CohortMean Monthly COPD-related Costs Per ParticipantCOPD-related total costs297 United States (US) dollarsStandard Deviation 1376.4
Other Maintenance Therapies CohortMean Monthly COPD-related Costs Per ParticipantCOPD-related pharmacy costs126 United States (US) dollarsStandard Deviation 307.7
Other Maintenance Therapies CohortMean Monthly COPD-related Costs Per ParticipantCOPD-related medical costs171 United States (US) dollarsStandard Deviation 1331.4
Secondary

Number of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years

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.

Time frame: 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

ArmMeasureGroupValue (NUMBER)
Fluticasone/Salmeterol Combination (FSC) CohortNumber of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-yearsCOPD-related hospitalization2.8 participants per 100 person-years
Fluticasone/Salmeterol Combination (FSC) CohortNumber of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-yearsCOPD-related ER visit6.6 participants per 100 person-years
Fluticasone/Salmeterol Combination (FSC) CohortNumber of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-yearsCOPD-related physician + Rx visit27.2 participants per 100 person-years
Fluticasone/Salmeterol Combination (FSC) CohortNumber of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-yearsCOPD-related hospitalization/ER visit/physician+Rx34.6 participants per 100 person-years
Other Maintenance Therapies CohortNumber of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-yearsCOPD-related hospitalization/ER visit/physician+Rx50.7 participants per 100 person-years
Other Maintenance Therapies CohortNumber of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-yearsCOPD-related hospitalization6.0 participants per 100 person-years
Other Maintenance Therapies CohortNumber of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-yearsCOPD-related physician + Rx visit37.4 participants per 100 person-years
Other Maintenance Therapies CohortNumber of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-yearsCOPD-related ER visit12.0 participants per 100 person-years
p-value: <0.0595% CI: [0.326, 1.109]Log Rank
p-value: <0.0595% CI: [0.434, 0.977]Log Rank
p-value: <0.0595% CI: [0.658, 1.008]Log Rank
p-value: <0.0595% CI: [0.649, 0.948]Log Rank

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026