Last updated: 11/07/2018 02:35:27

Step down of fluticasone propionate/salmeterol combination therapy in asthma

GSK study ID
109315
See study documents
Clinicaltrials.gov ID
Not applicable
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: A Retrospective Study of Healthcare Utilization and Costs of Step-Down Therapy in Asthma Patients Receiving Fluticasone Propionate/Salmeterol Combination
Trial description: The purpose of this study was to compare asthma related outcomes, including emergency department visits and hospitalzations. A meta-analysis of published and un-published studies that meet apriori criteria on length of study and outcomes measured for comparative trials of ICS vs ICS/LABA combination in pediatrics and ICS/LABA vs ICS/montelukast
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Asthma related systemic emergency department visit, and hospitalizations

Timeframe: Outcomes assessed at least 90 days post index

Secondary outcomes:

adherence to inhaled corticosteroids

Timeframe: at least 90 days post index

Interventions:
  • Drug: Fluticasone propionate
  • Drug: Fluticasone propionate/salmeterol combination
    • Enrollment:
    0
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Delea TE, Hagiwara M, Stempel DA, Stanford RH. Adding salmeterol to fluticasone propionate or increasing the dose of fluticasone propionate in patients with asthma. [Allergy Asthma Proc]. 2010;31(3):211-218.
    Medical condition
    Asthma
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    February 2008 to July 2009
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    12 - 64 Year
    Accepts healthy volunteers
    none
    • Asthma subjects identified with at least 1 ICD-9 code for asthma and >= 2 Rx claims of fluticasone propionate/salmeterol combination 250/50 or 500/50, prior to stepping down to fluticasone propionate/salmeterol 100/50 or 250/50 or fluticasone propionate 110 or 220.
    • Subjects with >= 1 ICD-9 code for COPD or use of anticholinergics
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Asthma subjects identified with at least 1 ICD-9 code for asthma and >= 2 Rx claims of fluticasone propionate/salmeterol combination 250/50 or 500/50, prior to stepping down to fluticasone propionate/salmeterol 100/50 or 250/50 or fluticasone propionate 110 or 220.
    Exclusion criteria:
    • Subjects with >= 1 ICD-9 code for COPD or use of anticholinergics

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    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
    2009-01-07

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website