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)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
2018-05-01
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)
No location data available.
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
Finalized
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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