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

Nanjing Medical University

Status: Enrolling

Conditions: Moderate to Severe Allergic Asthma

Treatments: Drug: IgE monoclonal antibody

Study type: Observational

Funder types: Other

Identifiers

NCT06348407

2024-BA-001

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 14 to 90 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

300 participants in 4 patient groups

Responder group

Description:

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.

Treatment:

Drug: IgE monoclonal antibody

No-Responder group

Description:

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

Treatment:

Drug: IgE monoclonal antibody

Good adherence

Description:

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.

Treatment:

Drug: IgE monoclonal antibody

Poor adherence

Description:

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

Treatment:

Drug: IgE monoclonal antibody