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

The First Affiliated Hospital with Nanjing Medical University300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Moderate to Severe Allergic Asthma

Interventions

IgE monoclonal antibodyDRUG

omalizumab

Medical Language ↔ Plain English

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.)

Outcomes

Primary Outcomes

Change in Asthma Control Test (ACT)

The responder in ACT was required to meet any of the following conditions:(a) an improvement in ACT score ≥ 3 (MID); and (b) a pre-treatment ACT score \< 20 (poor or poorly controlled asthma) and a post-treatment ACT score ≥ 20 (well controlled asthma).

Time frame: Baseline, up to16weeks，24weeks and 1year of treatment.

Global Evaluation of Treatment Effectiveness (GETE)

Global Evaluation of Treatment Effectiveness (GETE) score after omalizumab treatment. The responder in GETE is score of "excellent" or"good" after treatment.

Time frame: Baseline, up to16weeks，24weeks and 1year of treatment.

Secondary Outcomes

Forced Expiratory Volume in 1 second（FEV1)

Pre-bronchodilators FEV1 .

Time frame: Baseline, up to 16weeks，24weeks and 1year of treatment.

FEV1/predicted%.

Pre-bronchodilators FEV1/predicted%.

Time frame: Baseline, up to 16weeks，24weeks and 1year of treatment.

Forced Vital Capacity （FVC）

Pre-bronchodilators FVC

Time frame: Baseline, up to16weeks，24weeks and 1year of treatment.

FEV1/FVC.

Pre-bronchodilators FEV1/FVC.

Time frame: Baseline, up to16weeks，24weeks and 1year of treatment.

Number of Acute Exacerbations（AE）

Number of acute exacerbations 1 year before omalizumab treatment,and up to16weeks，24weeks and 1year of treatment.

Time frame: up to16weeks，24weeks and 1year of treatment.

Oral glucocorticoid dosage

Oral glucocorticoid dosage before and after omalizumab treatment

Time frame: up to16weeks，24weeks and 1year of treatment.

Good adherence

Adherence to omalizumab treatment in this study was assessed by examining the rates of missed doses,the proportion of patients who missed fewer than 10% of all doses over 1 years was good adherence.

Time frame: 1 year

Poor adherence

Adherence to omalizumab treatment in this study was assessed by examining the rates of missed doses,the proportion of patients who missed at least 10% of all doses over 1 year was poor adherence.

Time frame: 1 year

Adverse events

Incidence of adverse events = Number of subjects with adverse events/Total number of subjects in treatment×100%

Time frame: up to16weeks，24weeks and 1year of treatment.

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts