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

The Efficacy and Safety of Omalizumab in the Treatment of Moderate to Severe Allergic Asthma:A Retrospective Single-center Clinical Trial

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 Overview

• Status: Recruiting
• Conditions: Moderate to Severe Allergic Asthma
• Intervention / Treatment: Drug: IgE monoclonal antibody

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Linfu Zhou, Doctor; Phone Number: 86+13611573618; Email: linfu.zhou@126.com
• Study Contact Backup: Name: Xuejun Zhang, Master; Phone Number: 86+13704726254; Email: zxj1301@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • Linfu zhou
      • Contact: Xuejun Zhang, Master; Phone Number: 86+13704726254; Email: zxj1301@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with moderate to severe allergic asthma who received omalizumab at the First Affiliated Hospital with Nanjing Medical University from 2018 to 2023.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: IgE monoclonal antibody; omalizumab
No-Responder group; The improvement in ACT score < 3;The GETE score was moderate,poor and worse.	Drug: IgE monoclonal antibody; 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.	Drug: IgE monoclonal antibody; 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.	Drug: IgE monoclonal antibody; omalizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	Baseline, up to16weeks，24weeks and 1year of treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced Expiratory Volume in 1 second（FEV1)	Pre-bronchodilators FEV1 .	Baseline, up to 16weeks，24weeks and 1year of treatment.
FEV1/predicted%.	Pre-bronchodilators FEV1/predicted%.	Baseline, up to 16weeks，24weeks and 1year of treatment.
Forced Vital Capacity （FVC）	Pre-bronchodilators FVC	Baseline, up to16weeks，24weeks and 1year of treatment.
FEV1/FVC.	Pre-bronchodilators FEV1/FVC.	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.	up to16weeks，24weeks and 1year of treatment.
Oral glucocorticoid dosage	Oral glucocorticoid dosage before and after omalizumab treatment	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.	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.	1 year
Adverse events	Incidence of adverse events = Number of subjects with adverse events/Total number of subjects in treatment×100%	up to16weeks，24weeks and 1year of treatment.

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: asthma; omalizumab; allergy; IgE
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Antibodies, Monoclonal
• Other Study ID Numbers: 2024-BA-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Protect patient privacy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No