Last updated: 11/28/2022 07:20:04
Meta-analysis of studies MEA115588 and 200862 of mepolizumab (SB240563) to evaluate changes in AM PEF in severe eosinophilic asthma (eTrack Study Identifier 208091)
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 of studies MEA115588 and 200862 of mepolizumab (SB240563) to evaluate changes in AM PEF in severe eosinophilic asthma (eTrack Study Identifier 208091)
Trial description: The mepolizumab studies conducted in the past for evaluating changes in lung function (forced expiratory volume in one second [FEV1] and AM PEF) provided inconsistent results possibly due to lack of a well-defined target population based on a specific blood eosinophil threshold. It was observed that studies utilizing a blood eosinophil threshold of at least 150 cells/microliter (µL) at screening (or at least 300 cells/µL in the previous year) to select the target population produced more consistent results in lung function. Estimating the effect of mepolizumab in subgroups defined by eosinophil counts has been difficult to characterize based on data from a single study due to small sample sizes. Therefore, a meta-analysis will be conducted combining data from clinical studies of mepolizumab 100 milligrams (mg) subcutaneous (SC) in severe eosinophilic asthma to estimate the effect of mepolizumab on changes in AM PEF. The contributing studies for this meta-analysis included: MEA115588, a placebo controlled study which evaluated 75 mg intravenous (IV) dose and a 100 mg SC dose of mepolizumab given for 32 weeks and 200862, a Phase IIIa placebo controlled study which evaluated 100 mg SC dose of mepolizumab given for 24 weeks. AM PEF changes captured in an electronic diary (eDiary) from the start of treatment until completion of study or up to withdrawal (but no greater than 4 weeks after the last dose of study medication) will be included in the analysis.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Absolute and relative change from baseline in AM PEF
Timeframe: Baseline and up to 32 weeks
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2017-22-09
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Ortega H, Menzies-G A, Llanos JP, Forshag M, Albers, F, Gunsoy N, Bradford E, Yancey S, Kraft M. Rapid and Consistent Improvements in Morning PEF in Patients with Severe Eosinophilic Asthma Treated with Mepolizumab. Adv Ther. 2018;35(7):1059–1068.
DOI: 10.1007/s12325-018-0727-8
PMID: 29949045
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
August 2017 to September 2017
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
Not applicable
- Placebo-controlled studies of Nucala (mepolizumab 100 mg) SC in severe eosinophilic asthma in subjects with 2 or more exacerbations in past year.
- Studies utilizing a blood eosinophil threshold of at least 150 cells/µL at screening (or at least 300 cells/µL in the previous year) to select the target population
- Data from the 75 mg IV arm in study MEA115588 will be excluded from this meta-analysis
Inclusion and exclusion criteria
Inclusion criteria:
- Placebo-controlled studies of Nucala (mepolizumab 100 mg) SC in severe eosinophilic asthma in subjects with 2 or more exacerbations in past year.
- Studies utilizing a blood eosinophil threshold of at least 150 cells/µL at screening (or at least 300 cells/µL in the previous year) to select the target population
- Dose of maintenance oral corticosteroid kept constant throughout study
- Duration of at least 24 weeks
Exclusion criteria:
- Data from the 75 mg IV arm in study MEA115588 will be excluded from this meta-analysis
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
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
2017-22-09
Actual study completion date
2017-22-09
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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