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
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
Not applicable
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)

No location data available.

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
Finalized
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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