Last updated: 11/28/2022 09:00:05

Meta-analysis of the efficacy of mepolizumab in asthma subjects

GSK study ID
213079
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Efficacy of mepolizumab in patients with severe eosinophilic asthma by baseline oral steroid dose – meta-analysis from three ph3 trials
Trial description: This meta-analysis includes data of subjects who received mepolizumab 75 milligram (mg) intravenously (IV), which has been demonstrated to be bioequivalent to the 100 mg subcutaneous (SC) dose. The studies included in this meta-analysis were MEA112997 (NCT number: NCT01691859), MEA115588 (NCT number: NCT01691521) and 200862 (NCT number: NCT02281318). The study will determine the exacerbation reduction in subjects by oral corticosteroids (OCS) dose. The aim of this study is to determine that mepolizumab is more effective in subjects at lower doses of OCS.
Primary purpose:
Treatment
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of subjects with clinically significant asthma exacerbations

Timeframe: Up to Day 52

Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2019-23-08
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Lugogo N, Liu M, Pavord I, Mitchell P, Smith S, Mallett S, Albers F, Bradford E, Yancey S, Bel EH. Clinical effects of mepolizumab in patients with severe eosinophilic asthma according to background therapy: a meta-analysis. J Allergy Clin Immunol Pract. 2021; DOI: 10.1016/j.jaip.2021.05.024 PMID: 34111572
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
July 2019 to August 2019
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
  • Randomized placebo-controlled studies including mepolizumab 100mg SC and/or 75mg IV dose in severe eosinophilic asthma.
  • Duration of at least 24 weeks.
  • Subjects who were not receiving maintenance OCS therapy at Baseline.
Inclusion and exclusion criteria
Inclusion criteria:
  • Randomized placebo-controlled studies including mepolizumab 100mg SC and/or 75mg IV dose in severe eosinophilic asthma.
  • Duration of at least 24 weeks.
  • Studies where maintenance OCS use was kept constant.
Exclusion criteria:
  • Subjects who were not receiving maintenance OCS therapy at Baseline.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Statistical analysis plan
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

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
2019-23-08
Actual study completion date
2019-23-08

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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