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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Moderate to Severe Allergic Asthma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Responder group

The improvement in ACT score ≥ 3,or pre-treatment ACT score \< 20 and a post-treatment ACT score ≥ 20；The GETE score was excellent or good.

IgE monoclonal antibody

Intervention Type DRUG

omalizumab

No-Responder group

The improvement in ACT score \< 3;The GETE score was moderate,poor and worse.

IgE monoclonal antibody

Intervention Type DRUG

omalizumab

Good adherence

The proportion of patients whose missed doses of omalizumab fewer than 10% of all doses over the1 year, we think these patients were good adherence.

IgE monoclonal antibody

Intervention Type DRUG

omalizumab

Poor adherence

the proportion of patients who missed at least 10% of all doses over the 1year,we think these patients were poor adherence.

IgE monoclonal antibody

Intervention Type DRUG

omalizumab

Interventions

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IgE monoclonal antibody

omalizumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Moderate-to-severe asthma patients aged ≥ 14 years who met the criteria of the Asthma Group of the Chinese Thoracic Society (Guidelines for bronchial asthma prevention and management, 2020 edition)-moderate asthma was defined as those who could achieve complete control using grade 3 therapy, and severe asthma was defined as fully or incompletely controlled with grade 4 or 5 asthma medications.
* History of asthma exacerbations induced by allergen exposure , elevated total serum IgE and positive specific IgE test or positive skin prick test.
* Treatment with omalizumab.

Exclusion Criteria

* Hypersensitivity to the active ingredient of omalizumab.
* Asthma exacerbation in the baseline.
* Combined with diseases that severely affect ventilation,such as bronchiectasis, lung cancer, allergic bronchopulmonary aspergillosis (ABPA), acute respiratory infections, chronic obstructive pulmonary disease (COPD),etc.
* Receiving other biologically targeted therapies (e.g., anti-interleukin (IL)-5 monoclonal antibody, anti-IL-4 monoclonal antibody, anti-IL-13 monoclonal antibody, anti-IL-5 receptor α (IL-5Rα) monoclonal antibody, etc.)

Minimum Eligible Age

14 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No