NCT06348407

A Clinical Study of Omalizumab in the Treatment of Allergic Asthma(ESSENCE)

The Efficacy and Safety of Omalizumab in the Treatment of Moderate to Severe Allergic Asthma:A Retrospective Single-center Clinical Trial

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 14 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Allergic asthma being the most widespread and easily identifiable phenotype, accounting for 60-80% of cases.Previous studies have reported that nearly 90% of patients with severe asthma were cases of allergic asthma, in which Immunoglobulin E (IgE) plays a critical role.Omalizumab was approved as an anti-IgE humanized monoclonal antibody for the treatment of patients with poorly controlled moderate-to-severe asthma, and was the first targeted drug used in the field of asthma treatment.The drug was launched in mainland China in August 2017.whereas,the clinical application experience, effects, and relevant data in the domestic population still lacking.The aim of this study was to observe the efficacy and safety of omalizumab, and to investigate whether baseline clinical characteristics and biomarkers can predicted response and adherence to treatment.

Conditions

• Moderate to Severe Allergic Asthma

Interventions

Type	Name	Description
DRUG	IgE monoclonal antibody	omalizumab

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-11-30
• Completion: 2024-11-30
• First posted: 2024-04-04
• Last updated: 2024-04-04

Locations

1 site across 1 country: China