Last updated: 11/03/2018 15:44:42

Fluticasone propionate-salmeterol combination adherence in Patients with Chronic Obstructive Pulmonary Disease (COPD)

GSK study ID
113865
See study documents
Clinicaltrials.gov ID
NCT01381471
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: Fluticasone propionate-salmeterol combination adherence in Patients with Chronic Obstructive Pulmonary Disease (COPD)
Trial description: The specific aim of this study is to describe 1 year Advair dispensing rates for patients with COPD, and to measure the association between Advair adherence and healthcare utilization (e.g. emergency room visits and inpatient admissions, etc.). To compare the risk of a COPD exacerbation (moderate or severe) during a 3-month follow-up period between patients thqat are adherent versus those that are not.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Mean Number of Pharmacy Claims by Participants during the Post-Index Period

Timeframe: One Year

Mean Number of Healthcare Encounters Incurred by Participants during the Post-Index Period

Timeframe: One Year

Secondary outcomes:
Not applicable
Interventions:
  • Drug: fluticasone propionate/salmeterol xinafoate combination
    • Enrollment:
    11060
    Primary completion date:
    2010-01-01
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    August 2009 to January 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    No
    • INCLUSION CRITERIA
    • at least one pharmacy claim for Advair (any strength; Diskus or MDI) during the index year (July 1, 2005 through June 30, 2006).
    Inclusion and exclusion criteria
    Inclusion criteria:
    • INCLUSION CRITERIA
    • at least one pharmacy claim for Advair (any strength; Diskus or MDI) during the index year (July 1, 2005 through June 30, 2006).
    • Continuous medical and pharmacy eligibility for the 12 month Pre-Index year and the 12 month Index year (referred to as the 24 month Observation Period), and the 3 month Post-Index period (referred to as the Outcome Period).
    • At least one medical claim with a diagnosis (either primary or secondary) of COPD (ICD-9 code 490.xx, 491.xx, 492.xx, and 496), AND at least 1 pharmacy claim for an Anticholinergic medication, both occurring during the12 month pre-index period.
    • At least 40 years old at index date. EXCLUSION CRITERIA
    • any medical claim (ever) with a primary or secondary diagnosis of cystic fibrosis (ICD-9 code 277.0x).

    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
    2010-01-01
    Actual study completion date
    2010-01-01

    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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