Last updated: 11/03/2018 13:08:37

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

GSK study ID
112609
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: 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
Trial description: 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
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants having a hospitalization or emergency room (ER) visit related to chronic obstructive pulmonary disease (COPD) represented per 100 person-years

Timeframe: Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)

Secondary outcomes:

Number of participants having a COPD-related event related to chronic obstructive pulmonary disease (COPD) represented per 100 person-years

Timeframe: Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)

Mean Monthly COPD-related Costs Per Participant

Timeframe: Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)

Interventions:
Drug: fluticasone propionate/salmeterol xinafoate combination
Drug: Other maintenance Treatments (OMT)
Enrollment:
5677
Observational study model:
Cohort
Primary completion date:
2010-18-03
Time perspective:
Retrospective
Clinical publications:
Dalal AA et al, Am J Manag Care, 2011, 17(3):e55-e65
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;17(3):e55-e65.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
November 2009 to March 2010
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
  • 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

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
2010-18-03
Actual study completion date
2010-18-03

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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