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The specific aim of this study is to describe 1 year Advair dispensing rates for patients with COPD, and to measure the association between Advair adherence and healthcare utilization (e.g. emergency room visits and inpatient admissions, etc.). To compare the risk of a COPD exacerbation (moderate or severe) during a 3-month follow-up period between patients thqat are adherent versus those that are not.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD | Patients with a diagnosis code of COPD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluticasone propionate/salmeterol xinafoate combination | Drug | fluticasone propionate/salmeterol xinafoate combination |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Pharmacy Claims by Participants During the Post-Index Period | The mean number of pharmacy claims incurred by participants during the one-year post-index period was measured. | One Year |
| Mean Number of Healthcare Encounters Incurred by Participants During the Post-Index Period | The mean number of outpatient office visits, inpatient visits, and emergency department visits incurred by participants during the one-year post-index period was measured. | One Year |
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INCLUSION CRITERIA
EXCLUSION CRITERIA
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Patients 40 years of age or older with at least one pharmacy claim for FSC during the index date range (July 1, 2005 through June 30, 2006). An index date was designated as the date of the first pharmacy claim for FSC. Patients were also required to have continuous medical and pharmacy eligibility for the 12 month pre-Index year and the 12 month Index year (referred to as the 24 month observation period), and the 3 month post-Index outcome period (referred to as the outcome period). Eligible patients were further required to have at least one medical claim with a diagnosis (either primary or secondary) of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, and 496), AND at least 1 pharmacy claim for an anticholinergic medication, both occurring during the12 month pre-index period.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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Participants were not recruited or enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and were used to develop a cohort. All diagnoses and treatments are recorded in the course of routine medical practice.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluticasone Propionate/Salmeterol (FSC) | Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Revision [ICD-9], Clinical Modification codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluticasone Propionate/Salmeterol (FSC) | Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Revision [ICD-9], Clinical Modification [ICD-9] codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one1 pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Mean Number of Pharmacy Claims by Participants During the Post-Index Period | The mean number of pharmacy claims incurred by participants during the one-year post-index period was measured. | Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of COPD (ICD-9 codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x) | Posted | Mean | Standard Deviation | pharmacy claims | One Year |
|
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This is a retrospective study of pre-existing medical record and/or health insurance claims data; all data are de-identified, and thus no assessments of Serious or Non-serious Adverse Events are possible.
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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 Propionate/Salmeterol (FSC) | Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Revision [ICD-9], Clinical Modification codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
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| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Number of Participants with the Indicated Level of Adherence to FSC | Adherence levels were defined by the number of pharmacy claims for each participant in the year following the index date (an FSC claim from (July 1, 2005 to June 30, 2006). Three or fewer claims for FSC was considered low adherence, medium adherence was defined as 4 to 8 claims, and high adherence was defined as nine or more pharmacy claims. | Number | participants |
|
|
|
| Primary | Mean Number of Healthcare Encounters Incurred by Participants During the Post-Index Period | The mean number of outpatient office visits, inpatient visits, and emergency department visits incurred by participants during the one-year post-index period was measured. | Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of COPD (ICD-9 codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x) | Posted | Mean | Standard Deviation | healthcare encounters | One Year |
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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.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |
| Title | Measurements |
|---|---|
|