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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 90
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Linfu zhou
RECRUITING
Nanjing
Contact Information
Primary
Linfu Zhou, Doctor
linfu.zhou@126.com
86+13611573618
Backup
Xuejun Zhang, Master
zxj1301@163.com
86+13704726254
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2024-11-30
Participants
Target number of participants: 300
Treatments
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.
No-Responder group
The improvement in ACT score \< 3;The GETE score was moderate,poor and worse.
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.
Poor adherence
the proportion of patients who missed at least 10% of all doses over the 1year,we think these patients were poor adherence.
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital with Nanjing Medical University

This content was sourced from clinicaltrials.gov