Last updated: 11/07/2018 04:54:23

Outcomes for Medicare asthma patients taking fluticasone propionate/salmeterol xinafoate combination versus Inhaled Corticosteroids or other combination therapy

GSK study ID
112605
See study documents
Clinicaltrials.gov ID
NCT01347060
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 for Medicare asthma patients taking fluticasone propionate/salmeterol xinafoate combination versus Inhaled Corticosteroids or other combination therapy
Trial description: The objective of this study is to compare healthcare utilization and costs in Medicare-eligible asthma patients (aged >65) who receive fluticasone propionate/salmeterol xinafoate combination or inhaled corticosteroids in a typical clinical practice using a retrospective observational cohort study design of large managed care database. Outcomes on interest include asthma related severe exacerbations defined as asthma related emergency department visits, hospitalizations or combined emergency department/hospitalization. Other outcomes of interest include use of albuterol, oral corticosteroids and overall asthma related costs. Outcomes of interest will be compared between the two treatment cohorts (fluticasone propionate/salmeterol xinafoate combination or inhaled corticosteroids). Dichotomous outcomes (emergency visits, hospitalizations etc) will be compared using Cox regression hazards analysis assessing time to first event for each asthma related endpoint adjusting for differences in baseline demographics such as age, gender, previous asthma medication use, co morbidities, costs, and plan demographics. Total asthma related costs will also be compared using generalized linear models adjusting for baseline differences.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Mean number of post-index asthma-related events measured using medical and pharmacy claims

Timeframe: Up to 7 years from July 1, 2001 to June 30, 2008

Secondary outcomes:

Mean asthma-related costs in the post-index period

Timeframe: Up to 7 years from July 1, 2001 to June 30, 2008

Mean number of albuterol (short-acting β-Agonists) canisters dispensed per pharmacy claim per participant

Timeframe: Up to 7 years from July 1, 2001 to June 30, 2008

Interventions:
  • Drug: fluticasone propionate/salmeterol xinafoate combination
  • Drug: inhaled corticosteroids
    • Enrollment:
    17448
    Primary completion date:
    2010-01-04
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Stanford RH, Blanchette CM, Roberts MH, Petersen H, Fuhlbrigge AL.Effect of combination fluticasone propionate and salmeterol or inhaled corticosteroids on asthma-related outcomes in a Medicare eligible population.Am J Geriatr Pharmacother.2012;6(10):343-351
    Medical condition
    Asthma
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    July 2009 to April 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    65+ years
    Accepts healthy volunteers
    No
    • Subjects with asthma as determined by ICD-9 codes and asthma drug use
    • at least 65 years of age
    • a diagnosis of chronic obstructive pulmonary disease or
    • a prescription for a chronic obstructive pulmonary disease treatment
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects with asthma as determined by ICD-9 codes and asthma drug use
    • at least 65 years of age
    • prescription for an inhaled corticosteroid
    Exclusion criteria:
    • a diagnosis of chronic obstructive pulmonary disease or
    • a prescription for a chronic obstructive pulmonary disease treatment

    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
    2010-01-04
    Actual study completion date
    2010-01-04

    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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