Last updated: 11/07/2018 07:00:45

Observed outcomes associated with fluticasone propionate/salmeterol xinafoate or inhaled corticosteroids in asthma patients

GSK study ID
113903
See study documents
Clinicaltrials.gov ID
NCT01431924
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: Observed outcomes associated with fluticasone propionate/salmeterol xinafoate or inhaled corticosteroids in asthma patients
Trial description: This is an observational retrospective analysis of linked pharmacy and medical claims data from IMS Health/Pharmetrics database. which is a comprehensive, de-identified United States (US) healthcare claims database that is representative of the non-elderly, insurance-carrying population, The total population is 35.4 million. The average length of follow-up is 2.7 years mean (2.2 years median).
Subjects will be identified in the database that have at least one ICD-9 diagnostic code (493.xx) for asthma and at least 1 asthma treatment within a 12-month period prior to the index use of fluticsasone propionate/salmeterol xinafoate or inhaled corticosteroids. Subjects will be followed in the database until they have the event of interest (asthma-related emergency department visit, hospitalization, or oral corticosteroid use or combination of asthma-related emergency department/hospitalization or asthma-related emergency department/hospitalization/oral corticosteroids) or until they are lost to follow up whichever comes first. Subjects can be censored if they leave the database, have the event of interest, or are dispensed another asthma controller other than the medication of interest. All outcomes will be assessed in the follow-up period. Time-dependent statistical models adjusting for differences in baseline (pre-index) asthma and patient demographics will be used to compare asthma events.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Asthma-related exacerbations

Timeframe: Outcomes period is at least 90 days during 5-year study period

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Higher-dose inhaled corticosteroids
  • Drug: Low-dose fixed dose fluticasone propionate/salmeterol xinafoate combination
    • Enrollment:
    7779
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Hagiwara M, Delea TE, Stanford RH.Healthcare utilization and costs with fluticasone propionate and fluticasone propionate/salmeterol in asthma patients at risk for exacerbations. Allergy Asthma Proc.2014;35(1):54-62
    Medical condition
    Asthma
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    October 2010 to January 2012
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    12 - 65 years
    Accepts healthy volunteers
    No
    • One or more medical claims with a diagnosis (primary or secondary) of asthma (ICD-9-CM 493.XX) during study period;
    • One or more outpatient pharmacy claims during the study for one or more of the following “study medications”:
    • Patients with more than one of the study medications during the 3-month period beginning with the index date;
    • One or more prescriptions within three months of index date (pre or post) for an ICS or LABA other than the study medications
    Inclusion and exclusion criteria
    Inclusion criteria:
    • One or more medical claims with a diagnosis (primary or secondary) of asthma (ICD-9-CM 493.XX) during study period;
    • One or more outpatient pharmacy claims during the study for one or more of the following “study medications”:
    • Fluticasone propionate/salmeterol xinafoate 250 mcg/50 mcg or 100mcg/50mcg combinations
    • Fluticasone propionate 110 mcg or 220 mcg
    • One or more asthma exacerbations (asthma-related hospitalization or emergency department visit, oral corticosteriod prescription drug claim, or a combination of any of the above events) during the 12 months prior to the index date (“pre-index period”) or
    • Five or more prescriptions for a short-acting beta agonist during the pre-index period.
    Exclusion criteria:
    • Patients with more than one of the study medications during the 3-month period beginning with the index date;
    • One or more prescriptions within three months of index date (pre or post) for an ICS or LABA other than the study medications
    • One or more prescriptions within three months of post index date for:
    • Any asthma maintenance medication
    • Any medical claims during study period with a diagnosis of: Chronic obstructive pulmonary disease (COPD) (ICD-9-CM 491, 492, or 496); or Respiratory tract cancer (ICD-9-CM 160-164, or 231)

    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
    2012-03-01

    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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