Trial Outcomes & Findings for Fluticasone Propionate-salmeterol Combination Adherence in Patients With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT01381471)

Results Overview

The mean number of pharmacy claims incurred by participants during the one-year post-index period was measured.

Recruitment status

COMPLETED

Target enrollment

11060 participants

Primary outcome timeframe

One Year

Results posted on

2012-03-29

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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)
Overall Study STARTED	11060
Overall Study COMPLETED	11060
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fluticasone Propionate-salmeterol Combination Adherence in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluticasone Propionate/Salmeterol (FSC) n=11060 Participants 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)
Age Continuous	61.6 Years STANDARD_DEVIATION 9.4 • n=99 Participants
Sex: Female, Male Female	6103 Participants n=99 Participants
Sex: Female, Male Male	4957 Participants n=99 Participants
Number of Participants with the Indicated Level of Adherence to FSC Low adherence	2726 participants n=99 Participants
Number of Participants with the Indicated Level of Adherence to FSC Medium adherence	3479 participants n=99 Participants
Number of Participants with the Indicated Level of Adherence to FSC High adherence	4855 participants n=99 Participants

PRIMARY outcome

Timeframe: One Year

Population: 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)

The mean number of pharmacy claims incurred by participants during the one-year post-index period was measured.

Outcome measures

Outcome measures
Measure	Fluticasone Propionate/Salmeterol (FSC) n=11060 Participants 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)
Mean Number of Pharmacy Claims by Participants During the Post-Index Period Albuterol Pharmacy Claims	2.960 pharmacy claims Standard Deviation 4.627
Mean Number of Pharmacy Claims by Participants During the Post-Index Period Inhaled Corticosteriod Pharmacy Claims	0.219 pharmacy claims Standard Deviation 1.092
Mean Number of Pharmacy Claims by Participants During the Post-Index Period Anticholinergic Pharmacy Claims	5.491 pharmacy claims Standard Deviation 5.397
Mean Number of Pharmacy Claims by Participants During the Post-Index Period Theophylline Pharmacy Claims	0.573 pharmacy claims Standard Deviation 2.188
Mean Number of Pharmacy Claims by Participants During the Post-Index Period Oral Corticosteriod Pharmacy Claims	1.545 pharmacy claims Standard Deviation 2.727
Mean Number of Pharmacy Claims by Participants During the Post-Index Period Antibiotic Pharmacy Claims	2.181 pharmacy claims Standard Deviation 2.743

PRIMARY outcome

Timeframe: One Year

Population: 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)

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.

Outcome measures

Outcome measures
Measure	Fluticasone Propionate/Salmeterol (FSC) n=11060 Participants 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)
Mean Number of Healthcare Encounters Incurred by Participants During the Post-Index Period Outpatient Office Visits	2.048 healthcare encounters Standard Deviation 2.918
Mean Number of Healthcare Encounters Incurred by Participants During the Post-Index Period Emergency Department Visits	0.145 healthcare encounters Standard Deviation 0.788
Mean Number of Healthcare Encounters Incurred by Participants During the Post-Index Period Inpatient Visits	0.078 healthcare encounters Standard Deviation 0.353

Adverse Events

Fluticasone Propionate/Salmeterol (FSC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

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