Last updated: 07/11/2021 01:00:05
Meta-Analysis Plan for GSK sponsored studies MEA117113 and MEA117106 of Mepolizumab (SB240563) in COPD – Analysis to assess effect of mepolizumab on rate of exacerbations requiring an emergency department visit or hospitalization and rate of severe exacerbations (eTrack Study Identifier 207478)
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 GSK sponsored studies MEA117113 and MEA117106 of Mepolizumab (SB240563) in COPD – Analysis to assess effect of mepolizumab on rate of exacerbations requiring an emergency department visit or hospitalization and rate of severe exacerbations (eTrack Study Identifier 207478)
Trial description: This meta-analysis is primarily being conducted to generate estimates of the effect of mepolizumab on the frequency of exacerbations requiring an ED visit or hospitalization in subjects with chronic obstructive pulmonary disease (COPD) who meet the criteria of blood eosinophil count >=150 cells/microliter (μL) at screening or >=300 cells/μL in the 12 months prior, in addition the effect of mepolizumab on severe exacerbations will be determined. All randomized subjects who received at least one dose of study medication in two 52-week studies MEA117113 and MEA117106 (High Stratum) will be included in this meta-analysis. Summaries by treatment group will be presented for the individual studies, with treatment comparisons of each active treatment arm versus (vs.) placebo. In addition, summaries will also be presented for data combined from studies MEA117113 and MEA117106 (High Stratum) under the treatment groupings of placebo, 100 milligram (mg) subcutaneous (SC) and mepolizumab all doses along with treatment comparisons of mepolizumab 100 mg SC vs. placebo and mepolizumab all doses vs. placebo. Modified Intent-To-Treat Population consisted of all randomized subjects who received at least one dose of study medication.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Rate of exacerbations requiring ED visit or hospitalization
Timeframe: Up to 52 weeks
Time to first exacerbation requiring ED visit or hospitalization
Timeframe: Up to 52 weeks
Rate of severe exacerbations
Timeframe: Up to 52 weeks
Time to first severe exacerbation
Timeframe: Up to 52 weeks
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
1
Primary completion date:
2017-28-06
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Pavord I, Chapman K, Bafadhel M, Sciurba F, Bradford E, Harris S, Mayer B, Rubin D, Yancey S, Paggiaro P. Mepolizumab for eosinophil associated COPD: analysis of METREX and METREO. Int J Chron Obstruct Pulmon Dis. 2021;2021:1755-1770
DOI: 10.2147/COPD.S294333
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
May 2017 to June 2017
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
None
- For studies MEA117113 and MEA117106, subjects from modified Intent-To-Treat Population (consisting of all randomized subjects who received at least one dose of study medication, with subjects being analyzed based on the randomized treatment arm) and who meet the criteria of blood eosinophil count >=150 cells/μL at screening or >=300 cells/μL in the 12 months prior, will be included. This constitutes all subjects within MEA117113 and subjects identified as meeting this criteria based on actual data in MEA117106.
- Subjects who gave their consent for continued data collection.
- Not applicable.
Inclusion and exclusion criteria
Inclusion criteria:
- For studies MEA117113 and MEA117106, subjects from modified Intent-To-Treat Population (consisting of all randomized subjects who received at least one dose of study medication, with subjects being analyzed based on the randomized treatment arm) and who meet the criteria of blood eosinophil count >=150 cells/μL at screening or >=300 cells/μL in the 12 months prior, will be included. This constitutes all subjects within MEA117113 and subjects identified as meeting this criteria based on actual data in MEA117106.
- Subjects who gave their consent for continued data collection.
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
2017-28-06
Actual study completion date
2017-28-06
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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