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

Moderate to Severe Allergic Asthma Clinical Trial

— ESSENCE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06348407
• Other study ID #: 2024-BA-001
• Status: Recruiting
• Start date: December 1, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: March 2024
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Linfu Zhou, Doctor
• Phone: 86+13611573618
• Email: linfu.zhou[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 90 Years

Eligibility

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 a (IL-5Ra) monoclonal antibody, etc.)

Related Conditions & MeSH terms

• Asthma
• Moderate to Severe Allergic Asthma

Intervention

Drug:
• IgE monoclonal antibody
omalizumab

Locations

Country	Name	City	State
China	Linfu zhou	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Forced Expiratory Volume in 1 second(FEV1)	Pre-bronchodilators FEV1 .	Baseline, up to 16weeks,24weeks and 1year of treatment.
Secondary	FEV1/predicted%.	Pre-bronchodilators FEV1/predicted%.	Baseline, up to 16weeks,24weeks and 1year of treatment.
Secondary	Forced Vital Capacity (FVC)	Pre-bronchodilators FVC	Baseline, up to16weeks,24weeks and 1year of treatment.
Secondary	FEV1/FVC.	Pre-bronchodilators FEV1/FVC.	Baseline, up to16weeks,24weeks and 1year of treatment.
Secondary	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.
Secondary	Oral glucocorticoid dosage	Oral glucocorticoid dosage before and after omalizumab treatment	up to16weeks,24weeks and 1year of treatment.
Secondary	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
Secondary	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
Secondary	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.