Last updated: 11/07/2018 06:59:54

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

GSK study ID
113900
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Clinical and Economic Burden of Patients with Chronic Obstructive Pulmonary Disease in a Medicaid Population
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Incremental costs of COPD

Timeframe: 1 year

Secondary outcomes:

All-cause resource use

Timeframe: 1 year

COPD-related costs

Timeframe: 1 year

Interventions:
  • Other: Subjects with COPD
  • Other: Subjects without COPD
  • Enrollment:
    40884
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    D’Souza AO, Shah M, Dhamane AD, Dalal AA. Clinical and Economic Burden of COPD in a Medicaid Population. COPD. 2014;11(2):212-220
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    November 2010 to March 2011
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    No
    • 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
    • age less than 40 at index dates

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Scientific result summary
    Available language(s): English

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2011-01-03

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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