Last updated: 07/28/2020 14:50:11

A network meta-analysis comparing anti-IL5 treatments in severe eosinophilic asthma using aggregate data

GSK study ID
209020
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: A network meta-analysis comparing anti-IL5 treatments in severe eosinophilic asthma using aggregate data
Trial description: Asthma is an inflammatory lung condition characterized by the narrowing of the airways, breathlessness, a tight chest and reduced quality of life. Mepolizumab, reslizumab and benralizumab are developed for the treatment of severe eosinophilic asthma. All three treatments have been shown to significantly reduce clinically significant exacerbations. However, subjects included within clinical trials conducted for these biologics differ in relation to blood eosinophils thresholds for inclusion in the trial. Hence, it is not clear which treatment might benefit subjects with similar characteristics. Blood eosinophils act as an effect modifier for all three treatments. A comparison of the relative efficacy of these three biologics can help for treatment decisions in subjects with severe eosinophilic asthma. The purpose of this analysis is to compare licensed doses of anti-IL5 treatments for subjects with severe eosinophilic asthma accounting for differences in subject’s characteristics between studies. This network meta-analysis will be conducted using available data from randomized controlled trials comparing mepolizumab, reslizumab, and benralizumab versus placebo. Data will be collected from peer-reviewed publications, regulatory (Food and Drug Administration [FDA], European Medicines Agency [EMA]) and reimbursement National Institute for Health and Clinical Excellence [NICE] documents, and ClinicalTrials.gov [CT.gov]).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Annualized rate of ‘clinically significant’ exacerbations

Timeframe: Up to 56 weeks

Annualized rate of exacerbations

Timeframe: Up to 56 weeks

Change from Baseline in asthma control

Timeframe: Baseline and up to 56 weeks

Secondary outcomes:

Change from Baseline in pre-bronchodilator FEV1

Timeframe: Baseline and up to 56 weeks

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2018-15-06
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Busse W, Chupp G, Nagase H, Albers F, Doyle S, Shen Q, Bratton D, Gunsoy N. Anti-IL5 treatments in severe asthma by blood eosinophil thresholds: indirect treatment comparison. J Allergy Clin Immunol. 2018
Busse W, Chupp G, Nagase H, Albers F, Doyle S, Shen Q, Bratton D, Gunsoy N.Anti-IL5 treatments in severe asthma by blood eosinophil thresholds: indirect treatment comparison.J Allergy Clin Immunol.2019;143(1):190-200.e20 DOI: 10.1016/j.jaci.2018.08.031 PMID: 30205189
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
February 2018 to June 2018
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
Not applicable
  • Subjects from studies that satisfy following criteria were included in scope of this Network Meta-analysis:
  • Severe eosinophilic asthma subjects aged >=12 years.
  • Not Applicable

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Clinical study report
Available language(s): English
Protocol
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
2018-15-06
Actual study completion date
2018-15-06

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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