Clinical and Economic Burden of Patients With Chronic Obstructive Pulmonary Disease in a Medicaid Population

NCT ID: NCT01615783

Last Updated: 2012-06-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40884 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-03-31

Brief Summary

Reports suggest that the Medicaid population includes a higher percentage of smokers than the general population. A high prevalence of smokers in a population is likely to lead to a higher burden of chronic obstructive pulmonary disease (COPD). Few studies have evaluated the economic burden of COPD in a Medicaid population. The objective of this observational, retrospective cohort study is to estimate the economic burden of COPD in subjects with a COPD diagnosis who are enrolled in Medicaid and are receiving maintenance treatment covered by Medicaid.

Specifically, the null hypothesis for the primary outcome measure is that no difference is observed in all-cause costs between subjects with and without COPD. The test hypothesis is that there is a difference in all-cause costs between subjects with and without COPD.

Secondary outcomes to be evaluated include all-cause resource use and COPD-related costs for the COPD cohort.

The study uses a medical and pharmacy administrative claims database called MarketScan Medicaid Database that contains the medical, surgical, and prescription drug experience of nearly 7 million Medicaid recipients. This analysis will use data from 8 states.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Medicaid beneficiaries

Medicaid beneficiaries with at least one medical or pharmacy claim during each year in the identification period (2004-2006)

Subjects with COPD

Intervention Type: OTHER

Medicaid beneficiaries diagnosed with Chronic Obstructive Pulmonary Disease (COPD) and newly initiated on a maintenance medication

Subjects without COPD

Intervention Type: OTHER

Medicaid beneficiaries without a COPD diagnosis but having at least one medical or pharmacy claim during each year of the identification period

Interventions

Subjects with COPD

Medicaid beneficiaries diagnosed with Chronic Obstructive Pulmonary Disease (COPD) and newly initiated on a maintenance medication

Intervention Type: OTHER

Subjects without COPD

Medicaid beneficiaries without a COPD diagnosis but having at least one medical or pharmacy claim during each year of the identification period

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• at least 40 years of age at index date
• continuously eligible to receive healthcare services through Medicaid in the pre-index and follow-up period
• enrolled in fee-for-service plans
• without a diagnosis code of exclusionary comorbid conditions - cystic fibrosis, bronchiectasis, respiratory cancer, pulmonary fibrosis, pneumoconiosis, sarcoidosis, pulmonary tuberculosis (including fibrosis due to tuberculosis)

Exclusion Criteria

• age less than 40 at index dates

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

113900

Identifier Type: -

Identifier Source: org_study_id