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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD Patients | Patients over the age of 40 with a COPD-related hospital or ER visit |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluticasone propionate/salmeterol xinafoate combination | Drug | Patients filling a prescription for fluticasone/salmeterol combination as index drug |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria
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Managed care enrollees (aged >40 years) having at least one IP with primary or secondary diagnosis of COPD (ICD code 491.xx, 492.xx and 496.xx) or at least one ER visit with primary diagnosis of COPD (index event) during the study period was the target population
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21504260 | Background | Dalal AA, Shah M, D'Souza AO, Mapel DW. 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. Am J Manag Care. 2011 Mar 1;17(3):e55-65. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluticasone/Salmeterol Combination (FSC) Cohort | Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Other maintenance Treatments (OMT) | Drug | OMT group includes tiotropium, ipratropium alone or in combination with albuterol, inhaled steroids, long acting beta agonists |
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| Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008) |
| 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. | Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008) |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluticasone/Salmeterol Combination (FSC) Cohort | Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | Number | participants per 100 person-years | Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008) |
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| 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. | 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 | Posted | Number | participants per 100 person-years | Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008) |
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| 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. | 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 | Posted | Mean | Standard Deviation | United States (US) dollars | Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008) |
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This study was a retrospective observational study; thus, no serious adverse events or adverse events were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fluticasone/Salmeterol Combination (FSC) Cohort | Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day | 0 | 0 | 0 | 0 | ||
| EG001 | 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. | 0 | 0 | 0 | 0 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| D000069447 | Tiotropium Bromide |
| D009241 | Ipratropium |
| D000068600 | Albuterol, Ipratropium Drug Combination |
| D000068299 | Salmeterol Xinafoate |
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000068298 | Fluticasone |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D001286 | Atropine Derivatives |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
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| Male |
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| Units | Counts |
|---|---|
| Participants |
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