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
Study complete
Study complete
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
    Primary completion date:
    2010-18-03
    Observational study model:
    Cohort
    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)

    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
    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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