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

NCT06348407 | Recruiting DMC

• 1 other identifier: 2024-BA-001
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Moderate to Severe Allergic Asthma

Keywords

asthma; omalizumab; allergy; IgE

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Forced Expiratory Volume in 1 second（FEV1)

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

• FEV1/predicted%.

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

• Forced Vital Capacity （FVC）

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

• FEV1/FVC.

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

• Number of Acute Exacerbations（AE）

  up to16weeks，24weeks and 1year of treatment.

Study Arms (4)

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

No-Responder group

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

Drug: IgE monoclonal antibody

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

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

Interventions

IgE monoclonal antibody DRUG

omalizumab

Good adherence; No-Responder group; Poor adherence; Responder group

Eligibility Criteria

• Age: 14 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Linfu zhou

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Asthma; Hypersensitivity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Central Study Contacts

Linfu Zhou, Doctor

CONTACT

86+13611573618; linfu.zhou@126.com

Xuejun Zhang, Master

CONTACT

86+13704726254; zxj1301@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 4, 2024
• Study Start: December 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: April 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)