Last updated: 07/28/2020 14:40:05

Meta-analysis of studies MEA112997 and MEA115588 of mepolizumab (SB240563) in severe asthma – additional subgroup analyses of exacerbations and investigation of relationship of FEV1 to exacerbations (eTrack Study Identifier 207348)

GSK study ID
207348
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 of studies MEA112997 and MEA115588 of mepolizumab (SB240563) in severe asthma – additional subgroup analyses of exacerbations and investigation of relationship of FEV1 to exacerbations (eTrack Study Identifier 207348)
Trial description: Estimating the effect of mepolizumab in subgroups has been difficult to characterize based on data from a single study due to small sample sizes. Therefore, a meta-analysis of data from clinical studies of mepolizumab in severe asthma will be conducted to estimate the effect of mepolizumab on various endpoints in selected subgroups. The objectives of the meta-analyses are to estimate the effect of mepolizumab on exacerbation rates in subgroups of interest and to estimate the effect of exacerbations on lung function.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Annualised rate of clinically significant exacerbations

Timeframe: Approximately 1 year

Change from baseline in pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1)

Timeframe: Approximately 1 year

Change from baseline in pre-bronchodilator FVC

Timeframe: Approximately 1 year

Change from baseline in post-bronchodilator FEV1

Timeframe: Approximately 1 year

Change from baseline in post-bronchodilator FVC

Timeframe: Approximately 1 year

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Placebo
  • Drug: Mepolizumab
    • Enrollment:
    1
    Primary completion date:
    2018-05-01
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Ortega H, Yancey S, Keene O, Gunsoy N, Albers F, Howarth P. Asthma Exacerbations Associated with Lung Function Decline in Patients with Severe Eosinophilic Asthma. J Allergy Clin Immunol Pract. 2018;6(3):980-986.e1. DOI: 10.1016/j.jaip.2017.12.019 PMID: 29398640
    Medical condition
    Asthma
    Product
    mepolizumab
    Collaborators
    Not applicable
    Study date(s)
    September 2016 to January 2018
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    12+ years
    Accepts healthy volunteers
    Not applicable
    • Subjects who were enrolled in studies MEA112997 and MEA115588 and also were part of mITT Population.
    • Not applicable
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects who were enrolled in studies MEA112997 and MEA115588 and also were part of mITT Population.
    Exclusion criteria:
    • Not applicable

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Statistical analysis plan
    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
    2018-05-01
    Actual study completion date
    2018-05-01

    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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