Lead Investigator: Nermin Diab, McMaster University
Title of Proposal Research: Efficacy and safety of monoclonal antibodies in patients with uncontrolled asthma: a systematic review and network meta-analysis (2)
Vivli Data Request: 10462
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Asthma is a lung disorder that affects millions of individuals across the world. It is characterized by symptoms of reversible shortness of breath and wheezing. While most asthma is treated with inhaled medications (medicines that you breathe in), mainly inhaled steroids,which reduce the swelling in the airways by suppressing the inflammatory response, however some asthmatics have severe symptoms that are not relieved with conventional therapy and require certain injected molecules (substances introduced into the body by injection) for the treatment of their severe asthma. These injectable molecules are called “biologics”, which are drugs that are derived from living organisms or “monoclonal antibodies”, which are molecules designed to mimic the immune system’s ability to fight off harmful pathogens. There are currently multiple biologics approved for the treatment of asthma. However, data on their safety and efficacy when compared to each other is lacking. This study aims to compare the safety and efficacy of biologics used to treat severe asthma through a research methodology called network meta-analysis (NMA). This methodology of research will allow the comparison of various biologics to each other, even if they have not been studied directly against each other in real life.
Requested Studies:
A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre 24-week Study to Evaluate the Efficacy and Safety of Mepolizumab Adjunctive Therapy in Subjects With Severe Eosinophilic Asthma on Markers of Asthma Control
Data Contributor: GlaxoSmithKline
Study ID: NCT02281318
Sponsor ID: 200862
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging Study to Determine the Effect of Mepolizumab on Exacerbation Rates in Subjects With Severe Uncontrolled Refractory Asthma
Data Contributor: GlaxoSmithKline
Study ID: NCT01000506
Sponsor ID: 112997
MEA115575: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of Mepolizumab Adjunctive Therapy to Reduce Steroid Use in Subjects With Severe Refractory Asthma
Data Contributor: GlaxoSmithKline
Study ID: NCT01691508
Sponsor ID: 115575
A Multi-center, Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Compare Cessation Versus Continuation of Long-term Mepolizumab Treatment in Patients With Severe Eosinophilic Asthma (201810)
Data Contributor: GlaxoSmithKline
Study ID: NCT02555371
Sponsor ID: 201810
A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose Study to Evaluate the Efficacy and Safety of Intravenous GSK679586 in Patients With Severe Asthma
Data Contributor: GlaxoSmithKline
Study ID: NCT00843193
Sponsor ID: 106870
A Double Blind (Sponsor Open) Placebo-controlled, Stratified, Parallel Group Study to Evaluate the Efficacy and Safety of Repeat Doses of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)
Data Contributor: GlaxoSmithKline
Study ID: NCT03393806
Sponsor ID: 207972
A Randomised, Double-blind, Parallel Group PhIII Study to Assess the Clinical Efficacy and Safety of 100 mg SC Mepolizumab as an Add on to Maintenance Treatment in Adults With Severe Bilateral Nasal Polyps – SYNAPSE (StudY in NAsal Polyps Patients to Assess the Safety and Efficacy of Mepolizumab)
Data Contributor: GlaxoSmithKline
Study ID: NCT03085797
Sponsor ID: 205687
A Randomized, Double-blind, Parallel Group, Multicenter, Stratified Study Evaluating the Efficacy and Safety of Repeat Doses of GSK3772847 Compared With Placebo in Participants With Moderately Severe Asthma
Data Contributor: GlaxoSmithKline
Study ID: NCT03207243
Sponsor ID: 207597
MEA115588 A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel-group, Multi-centre Study of the Efficacy and Safety of Mepolizumab Adjunctive Therapy in Subjects With Severe Uncontrolled Refractory Asthma
Data Contributor: GlaxoSmithKline
Study ID: NCT01691521
Sponsor ID: 115588
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 148 Administered Subcutaneously in Symptomatic Subjects With Severe Persistent Asthma
Data Contributor: Johnson & Johnson
Study ID: NCT00207740
Sponsor ID: CR005281
Mechanisms Underlying Asthma Exacerbations Prevented and Persistent With Immune-Based Therapy: A Systems Approach Phase 2 (ICAC-30)
Data Contributor: ImmPort (a data-sharing platform funded by the National Institutes of Health)
Study ID: NCT03292588
Sponsor ID: SDY1903
Inner-City Anti-IgE Therapy for Asthma (ICAC-08)
Data Contributor: ImmPort (a data-sharing platform funded by the National Institutes of Health)
Study ID: NCT00377572
Sponsor ID: SDY211
Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations (ICAC-20)
Data Contributor: ImmPort (a data-sharing platform funded by the National Institutes of Health)
Study ID: NCT01430403
Sponsor ID: SDY1028