Last updated: 11/03/2018 22:32:53

Summary Document Analysis Plan for the Meta-Analysis and Assessment of Serious Event Outcomes in Patients with Persistent Asthma Receiving Salmeterol in Combination with Fluticasone as ADVAIR

GSK study ID
203821
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: Summary Document Analysis Plan for the Meta-Analysis and Assessment of Serious Event Outcomes in Patients with Persistent Asthma Receiving Salmeterol in Combination with Fluticasone as ADVAIR
Trial description: The primary objective is to assess the association of ADVAIR compared to FP in the incidence of subjects experiencing the following event outcomes: asthma-related hospitalization, asthma-related intubation, and asthma-related death. The incidence of subjects experiencing an event outcome in the composite endpoint of asthma-related hospitalization, asthma-related intubation, or asthma-related death will be the primary endpoint. The incidence of subjects experiencing an event outcome in the composite endpoint as described above per subject-year exposure will also determined.
The secondary objective is to assess the association of ADVAIR compared with FP in the incidence of subjects experiencing the following event outcomes: asthma-related hospitalization, asthma-related intubation, and asthma-related death in the subpopulations of pediatric subjects and adult subjects and in the subpopulation of African-American subjects. The incidence of subjects experiencing an event outcome in the composite endpoint of asthma-related hospitalization, asthma-related intubation, or asthma-related death will be the primary endpoint in each of these subpopulations.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Asthma-related hospitalization

Timeframe: N/A

Secondary outcomes:
Not applicable
Interventions:
  • Drug: FP/Salmeterol
  • Drug: FP
    • 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)
    February 2015 to February 2015
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    4+ years
    Accepts healthy volunteers
    none
    • N/A
    Inclusion and exclusion criteria
    Inclusion criteria:
    • N/A -

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    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
    2015-16-02

    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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