Last updated: 11/07/2018 04:54:11

Outcomes in patients taking fluticasone propionate/salmeterol combination or other inhaled corticosteroids

GSK study ID
112604
See study documents
Clinicaltrials.gov ID
NCT01332344
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: Comparison of Healthcare Utilization and Costs in Patients with Asthma who Fluticasone/Salmeterol Inhalation Powder versus other Inhaled Corticosteroid(s) in Typical Clinical Practice Using Health Insurance Claims Data.
Trial description: The objective of this study is to compare healthcare utilization and costs in asthma patients who receive fluticasone propionate/salmeterol combination 100mcg/50mcg (“FSC 100/50”) or inhaled corticosteriods in typical clinical practice using a retrospective observational cohort study design of large managed care database.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

To assess the difference in asthma related exacerbations

Timeframe: 90 days post index

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Fluticasone propionate/salmeterol combination
  • Drug: Inhaled corticosteroids
    • Enrollment:
    5180
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Hagiwara M, Delea T, Stanford RS.Risk of asthma exacerbation, asthma-related healthcare utilization and costs, and adherence to controller therapy in patients with asthma receiving fluticasone propionate/salmeterol inhalation powder 100mcg/50mcg vs. mometasone furoate inhalation powder.J Asthma.2013;50(3):287-295
    Medical condition
    Asthma
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    June 2009 to December 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    12 - 65 years
    Accepts healthy volunteers
    No
    • Subjects with asthma as determined by ICD-9 codes and asthma drug use
    • at least 12 years of age
    • Subjects with COPD or treatment for COPD
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects with asthma as determined by ICD-9 codes and asthma drug use
    • at least 12 years of age
    • treated with inhaled corticosteroids
    Exclusion criteria:
    • Subjects with COPD or treatment for COPD

    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
    Not applicable
    Actual study completion date
    2010-15-12

    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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