Last updated: 11/03/2018 13:11:59

Outcomes and Costs Associated with initiating Maintenance Treatment with Fluticasone Propionate 250mcg/Salmeterol xinafoate 50mcg Combination (FSC) Versus Anticholinergics including Tiotropium (TIO) in Patients with Chronic Obstructive Pulmonary Disease (COPD)

GSK study ID
112646
See study documents
Clinicaltrials.gov ID
NCT01331694
See results summary
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: Outcomes and Costs Associated with initiating Maintenance Treatment with Fluticasone Propionate 250mcg/Salmeterol xinafoate 50mcg Combination (FSC) Versus Anticholinergics including Tiotropium (TIO) in Patients with Chronic Obstructive Pulmonary Disease (COPD)
Trial description: To evaluate COPD-related clinical outcomes and total healthcare utilization in commercially insured (at least 40 years with a subanalysis of those aged 65 years and older) COPD population associated with the use of fluticasone/salmeterol combination (FSC) 250/50mcg compared to other initial maintenance therapies (IMTs), specifically, tiotropium bromide (TIO), and either ipratropium bromide or ipratropium bromide/albuterol (IP).
This is a hypothesis testing study
Ho: There is no difference in time to first COPD-related events between FSC and TIO and FSC and IP
Ha: There is a difference in time to first COPD-related events between FSC and TIO and FSC and IP
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 TIO and FSC and IP
Ha: There is a difference in COPD-related costs between FSC and TIO and FSC and IP
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Time to first chronic obstructive pulmonary disease (COPD) event

Timeframe: Anytime from 30 days to 12 months after initial treatment arm prescription

Secondary outcomes:

Average Annual Adjusted Post-Index COPD-Related Costs

Timeframe: Incurred over the 12 month period after initial treatment arm prescription

Interventions:
  • Drug: fluticasone/salmeterol combination (FSC) 250/50mcg
  • Drug: tiotropium
  • Drug: ipratropium bromide alone or in fixed dose combination with albuterol
    • Enrollment:
    76130
    Primary completion date:
    2010-07-05
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Dalal AA, Roberts MH, Petersen HV, Blanchette CM, Mapel DW. Comparative cost-effectiveness of a fluticasonepropionate/salmeterol combination versus anticholinergics as initial maintenance therapy for chronic obstructive pulmonary disease. International Journal of COPD 2011:6 13–22
    Dalal AA, Roberts MH, Petersen HV, Blanchette CM, Mapel DW. Comparative cost-effectiveness of a fluticasone-propionate/salmeterol combination versus anticholinergics as initial maintenance therapy for chronic obstructive pulmonary disease. [Int J Chron Obstruct Pulmon Dis]. 2011;6:13-22.
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    July 2009 to May 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    No
    • Inclusion Criteria –
    • IMT Cohorts (subjects selected by order of criteria)
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria – IMT Cohorts (subjects selected by order of criteria)
    • claim for one of the study medications and must not receive another study medication within 60 days of the initial maintenance therapy, indicating “intent to treat.”
    • at least one COPD-related ED or one COPD-related hospitalization, or two COPD-related outpatient visits (OV) associated with primary or secondary diagnosis for COPD (ICD-9-CM code 491.xx, 492.xx or 496.xx), at any time during the observation period (July 1, 2005 through June 30, 2008) in the database.
    • Aged 65+ years on the index date or aged 40 and over for the sub-analysis.
    • Continuous enrollment in a health plan for at least 6 months prior (pre-index) to initiation of IMT and at least three months after the first initiation of IMT (post-index).
    • at least one prescription claim in the pre-index and each year of the post-index period for which they have follow-up. Exclusion Criteria – All Cohorts
    • primary or secondary diagnosis of respiratory tract cancer (larynx, trachea, or pleura). (ICD-9-CM codes 161, 161.X, 162, 163, 163.X, 231, 231.X).
    • In the pre-index period, no claims for any of the cohort IMT medications, nor for any other Advair or budesonide/formoterol fixed dose combination, FSC combination medications, and may only have respiratory medication pharmacy claims for drugs included in the pre-index severity of illness assessment (Methylxanthines, Leukotriene Modifiers/Inhibitors, Omalizumab and Mast Cell Stabilizers).

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

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

    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
    2010-07-05
    Actual study completion date
    2010-07-05

    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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