RecruitingNCT06348407

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

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

300 participants

Start Date

Dec 1, 2023

Study Type

OBSERVATIONAL

Conditions

Moderate to Severe Allergic Asthma

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.

Eligibility

Min Age: 14 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates how well omalizumab (Xolair) — an injectable medication that targets a key molecule involved in allergic reactions — works in real-world patients with moderate-to-severe allergic asthma in China. It focuses on tracking symptoms, triggers, and treatment response over time. **You may be eligible if...** - You are 14 years old or older - You have moderate-to-severe allergic asthma that is triggered by allergen exposure - You have elevated allergy antibody levels (IgE) and positive allergy testing - You are currently being treated with or are starting omalizumab **You may NOT be eligible if...** - You are allergic to omalizumab or its ingredients - You are currently experiencing an asthma flare-up (acute exacerbation) - You have another serious lung condition (such as bronchiectasis) that significantly affects your breathing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIgE monoclonal antibody

omalizumab

Locations(1)

Linfu zhou

Nanjing, Jiangsu, China

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NCT06348407