Last updated: 07/28/2020 14:50:11
A network meta-analysis comparing anti-IL5 treatments in severe eosinophilic asthma using aggregate data
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
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
- 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
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects from studies that satisfy following criteria were included in scope of this Network Meta-analysis:
- Severe eosinophilic asthma subjects aged >=12 years.
- Randomized, double-blind, controlled trials comparing Mepolizumab 100 milligrams (mg) subcutaneous (SC), Reslizumab 3 milligrams per kilograms (mg/kg) and Benralizumab 30 mg every 8 weeks (Q8W) versus any comparators will be in scope of this analysis.
- Studies with outcomes as; Exacerbations, Exacerbations requiring emergency room visit or hospitalization(s), ACQ score and Pre-bronchodilator FEV1 will be in scope of this analysis.
- There are no date or language restrictions on the literature search for this analysis.
Exclusion criteria:
- 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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