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

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: fluticasone propionate/salmeterol xinafoate combination; Drug: Other maintenance Treatments (OMT)

• Study Type: Observational
• Enrollment (Actual): 5677

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

COPD Patients; Patients over the age of 40 with a COPD-related hospital or ER visit

Drug: fluticasone propionate/salmeterol xinafoate combination; Patients filling a prescription for fluticasone/salmeterol combination as index drug; Other Names: Advair (TM); Drug: Other maintenance Treatments (OMT); OMT group includes tiotropium, ipratropium alone or in combination with albuterol, inhaled steroids, long acting beta agonists; Other Names: Spiriva (TM); Atrovent (TM); Combivent (TM); Serevent (TM); Foradil (TM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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.	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)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: March 18, 2011
• First Submitted That Met QC Criteria: March 18, 2011
• First Posted (Estimate): April 11, 2011

Study Record Updates

• Last Update Posted (Actual): June 27, 2017
• Last Update Submitted That Met QC Criteria: June 1, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Emergencies; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Adrenergic Agonists; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Fluticasone; Xhance; Salmeterol Xinafoate
• Other Study ID Numbers: 112609