Last updated: 11/03/2018 13:27:11

Meta-analysis of observational studies of Fluticasone propionate/salmeterol combination.

GSK study ID
112708
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: Control of Asthma With Addition of Long-Acting Beta-Agonists to Inhaled Corticosteroid Regimens Systematic Review A Meta-analysis of Observational Studies
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 emergency department or hospitalizatons

Timeframe: over at least 6 months post exposure

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Fluticasone propionate/salmeterol combination
  • Drug: Inhaled corticosteroids
    • Enrollment:
    0
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Asthma
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    September 2008 to November 2008
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • Studies that compared fluticasone propionate/salmeterol and inhaled corticosteroids in asthma, Primary, observational, non-interventional, comparative studies of retrospective or prospective design. number of patients in each study cohort, treatment protocol (i.e., medications and doses used). Evaluation of, and preferably adjustment for, differences in baseline severity between groups.
    • . Reviews, meta-analyses, controlled trials, and studies published only in abstract form were excluded.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Studies that compared fluticasone propionate/salmeterol and inhaled corticosteroids in asthma, Primary, observational, non-interventional, comparative studies of retrospective or prospective design. number of patients in each study cohort, treatment protocol (i.e., medications and doses used). Evaluation of, and preferably adjustment for, differences in baseline severity between groups.
    Exclusion criteria:
    • . Reviews, meta-analyses, controlled trials, and studies published only in abstract form were excluded.

    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
    2008-19-11

    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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