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

Recruiting

• Conditions: Moderate to Severe Allergic Asthma
• Interventions: Drug: IgE monoclonal antibody

• Registration Number: NCT06348407
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-21
• Study First Submitted QC: 2024-03-28
• Last Update Submitted: 2024-03-28
• Study First Posted: 2024-04-04
• Last Update Posted: 2024-04-04
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No-Responder group	IgE monoclonal antibody	The improvement in ACT score \< 3;The GETE score was moderate,poor and worse.
Good adherence	IgE monoclonal antibody	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.
Poor adherence	IgE monoclonal antibody	the proportion of patients who missed at least 10% of all doses over the 1year,we think these patients were poor adherence.
Responder group	IgE monoclonal antibody	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.

Primary Outcome Measures

Name	Time	Method
Global Evaluation of Treatment Effectiveness (GETE)	Baseline, up to16weeks，24weeks and 1year of treatment.	Global Evaluation of Treatment Effectiveness (GETE) score after omalizumab treatment. The responder in GETE is score of "excellent" or"good" after treatment.
Change in Asthma Control Test (ACT)	Baseline, up to16weeks，24weeks and 1year of treatment.	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).

Secondary Outcome Measures

Name	Time	Method
Forced Expiratory Volume in 1 second（FEV1)	Baseline, up to 16weeks，24weeks and 1year of treatment.	Pre-bronchodilators FEV1 .
Oral glucocorticoid dosage	up to16weeks，24weeks and 1year of treatment.	Oral glucocorticoid dosage before and after omalizumab treatment
Good adherence	1 year	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.
Forced Vital Capacity （FVC）	Baseline, up to16weeks，24weeks and 1year of treatment.	Pre-bronchodilators FVC
Number of Acute Exacerbations（AE）	up to16weeks，24weeks and 1year of treatment.	Number of acute exacerbations 1 year before omalizumab treatment,and up to16weeks，24weeks and 1year of treatment.
Adverse events	up to16weeks，24weeks and 1year of treatment.	Incidence of adverse events = Number of subjects with adverse events/Total number of subjects in treatment×100%
FEV1/predicted%.	Baseline, up to 16weeks，24weeks and 1year of treatment.	Pre-bronchodilators FEV1/predicted%.
Poor adherence	1 year	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.
FEV1/FVC.	Baseline, up to16weeks，24weeks and 1year of treatment.	Pre-bronchodilators FEV1/FVC.

Trial Locations

Locations (1)

Linfu zhou; 🇨🇳 Nanjing, Jiangsu, China