Last updated: 11/07/2018 12:35:17

Meta-Analysis in sponsored studies MEA112997, MEA115588, and MEA115575 and a proof of concept investigator sponsored study CRT110184 of Mepolizumab in Severe Asthma

GSK study ID
204664
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: Meta-Analysis in sponsored studies MEA112997, MEA115588, and MEA115575 and a proof of concept investigator sponsored study CRT110184 of Mepolizumab in Severe Asthma
Trial description: The analyses described in this document are being conducted to generate estimates of the effect of mepolizumab on exacerbations requiring hospitalisation/ED visits and hospitalisation alone which are observed at relatively low frequencies in individual studies. Exacerbations requiring hospitalization/ED visits are serious for patients, but are difficult to study in a single randomised controlled clinical trial as they occur relatively infrequently.
The meta-analysis will also investigate the relationship between efficacy endpoints and blood eosinophils providing further information on the relationship between baseline blood eosinophils thresholds and the effects of treatment with mepolizumab.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Meta analysis of the effect of mepolizumab vs placebo on rates of exacerbations requiring hospitalisation/ED visits and hospitalisations alone

Timeframe: N/A

Secondary outcomes:

Duration of hospital stay; Change from Baseline Pre-bronchodilator FEV1; Change from Baseline Post-bronchodilator FEV1; FEV/FVC Ratio; ACQ; and SGRQ

Timeframe: N/A

Interventions:
  • Drug: Mepolizumab
  • Drug: Placebo
    • Enrollment:
    0
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Yancey S, Ortega H, Keene O, Mayer B, Gunsoy N, Brightling C, Bleecker E, Haldar P, Pavord I.Meta-analysis of asthma-related hospitalization in mepolizumab studies of severe eosinophilic asthma.J Allergy Clin Immunol.2017;139(4):1167-75
    Medical condition
    Asthma
    Product
    mepolizumab
    Collaborators
    Not applicable
    Study date(s)
    April 2015 to May 2015
    Type
    Observational
    Phase
    2/3

    Participation criteria

    Sex
    Female & Male
    Age
    12+ 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
    2015-30-05

    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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