Last updated: 07/11/2021 01:00:31
Meta-analysis of clinical studies of mepolizumab in participants with severe eosinophilic asthma
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Meta-Analysis Plan for 209140, a meta-analysis of studies MEA112997, MEA115588, MEA115575 and 200862 of mepolizumab (SB240563) to characterize efficacy in patients with co-morbidities and OCS-related complications in addition to severe eosinophilic asthma
Trial description: Comorbidities are coexisting conditions that could have significant influence on the management of asthma. There has been limited data published which describes the influence of comorbid conditions on treatment interventions in severe eosinophilic asthma. The effect of mepolizumab on rate of exacerbations and other markers of asthma control in participants with comorbidities of interest has been difficult to assess based on data from a single study due to small sample sizes. Therefore, meta-analyses of data from clinical studies of mepolizumab in severe eosinophilic asthma will be conducted to estimate the effect of mepolizumab on various endpoints in this population. This study provides details of the proposed meta-analysis of clinical studies (MEA112997, MEA115588, MEA115575 and 200862 of mepolizumab [SB240563]) in severe eosinophilic asthma to characterize efficacy in participants with comorbidities and oral corticosteroid (OCS)-related complications in addition to severe eosinophilic asthma.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with clinically significant exacerbations
Timeframe: Up to Week 52
Change from Baseline in St. George’s respiratory questionnaire (SGRQ) score
Timeframe: Baseline and up to Week 32
Change from Baseline in asthma control questionnaire (ACQ)-5 score
Timeframe: Baseline and up to Week 24
Change from Baseline in pre-bronchodilator forced expiratory volume (FEV1)
Timeframe: Baseline and up to Week 24
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2018-28-06
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Gibson P, Prazma C, Chupp G, Bradford E, Forshag M, Mallett S, Yancey S, Smith S, Bel E. Mepolizumab improves clinical outcomes in patients with severe asthma and comorbid conditions. Respir Res. 2021;22(Article number 171)
DOI: 10.1186/s12931-021-01746-4
PMID: 34098955
Medical condition
Asthma
Product
mepolizumab
Collaborators
NA
Study date(s)
April 2018 to June 2018
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- GSK-sponsored, placebo-controlled studies of mepolizumab in severe eosinophilic asthma.
- Duration of at least 24 weeks
- Not Applicable
Inclusion and exclusion criteria
Inclusion criteria:
- GSK-sponsored, placebo-controlled studies of mepolizumab in severe eosinophilic asthma.
- Duration of at least 24 weeks
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
Scientific result summary
Available language(s): English
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
2018-28-06
Actual study completion date
2018-28-06
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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