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Post Marketing Surveillance for Mepolizumab Auto-Injector

An observational, 24 week, open-label, multi-center, prospective post marketing surveillance study to evaluate the safety, tolerability and patient treatment experience (PTE) of mepolizumab administration via autoinjector for adult patients aged 18 years or older suffering with severe eosinophilic asthma.

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/09/045934
Enrollment
150
Registered
2022-09-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J82- Pulmonary eosinophilia, not elsewhere classified

Interventions

Intervention1: NIL: NIL

Sponsors

GlaxoSmithKline Pharmaceuticals Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients suffering from severe refractory eosinophilic asthma who have an indication from prescribing physician to start or have already started an add on treatment of mepolizumab by SC administration by patients or caregivers at home or healthcare providers in-clinic using a ready to use prefilled autoinjector

Exclusion criteria

Exclusion criteria: Patients with other conditions that could lead to elevated eosinophils such as Hyper eosinophilic Syndromes including Churg-Strauss Syndrome or Eosinophilic Esophagitis Patients with a known pre existing parasitic infestation within 6 months prior to Visit 1 should be treated appropriately before inclusion in the study

Design outcomes

Primary

MeasureTime frame
incidence of adverse events (AE), serious adverse events (SAE) and adverse events of special interest (AESI)Timepoint: 24 weeks

Secondary

MeasureTime frame
1. Frequency and incidence of clinically significant asthma exacerbations in the pre and 24-week post-exposure period with mepolizumab treatment. 2. Frequency and incidence of clinically significant asthma exacerbations requiring ED visits and/or hospitalization (24 weeks pre and post-exposure period). Timepoint: 24 weeks

Countries

India

Contacts

Public ContactDr Aanchal Gvalani

GlaxloSmithKline Pharmaceuticals Ltd

aanchal.a.gvalani@gsk.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026