Last updated: 11/07/2018 12:35:17
Meta-Analysis in sponsored studies MEA112997, MEA115588, and MEA115575 and a proof of concept investigator sponsored study CRT110184 of Mepolizumab in Severe Asthma
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Meta-Analysis in sponsored studies MEA112997, MEA115588, and MEA115575 and a proof of concept investigator sponsored study CRT110184 of Mepolizumab in Severe Asthma
Trial description: The analyses described in this document are being conducted to generate estimates of the effect of mepolizumab on exacerbations requiring hospitalisation/ED visits and hospitalisation alone which are observed at relatively low frequencies in individual studies. Exacerbations requiring hospitalization/ED visits are serious for patients, but are difficult to study in a single randomised controlled clinical trial as they occur relatively infrequently. The meta-analysis will also investigate the relationship between efficacy endpoints and blood eosinophils providing further information on the relationship between baseline blood eosinophils thresholds and the effects of treatment with mepolizumab.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Meta analysis of the effect of mepolizumab vs placebo on rates of exacerbations requiring hospitalisation/ED visits and hospitalisations alone
Timeframe: N/A
Secondary outcomes:
Duration of hospital stay; Change from Baseline Pre-bronchodilator FEV1; Change from Baseline Post-bronchodilator FEV1; FEV/FVC Ratio; ACQ; and SGRQ
Timeframe: N/A
Interventions:
Drug: Mepolizumab
Drug: Placebo
Enrollment:
0
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Yancey S, Ortega H, Keene O, Mayer B, Gunsoy N, Brightling C, Bleecker E, Haldar P, Pavord I.Meta-analysis of asthma-related hospitalization in mepolizumab studies of severe eosinophilic asthma.J Allergy Clin Immunol.2017;139(4):1167-75
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
April 2015 to May 2015
Type
Observational
Phase
2/3
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
none
- N/A
Inclusion and exclusion criteria
Inclusion criteria:
- N/A
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
Protocol
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
Not applicable
Actual study completion date
2015-30-05
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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