Clinical trial NCT06348407: A Clinical Study of Omalizumab in the Treatment of Allergic Asthma(ESSENCE)
Official title: The Efficacy and Safety of Omalizumab in the Treatment of Moderate to Severe Allergic Asthma:A Retrospective Single-center Clinical Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Moderate to Severe Allergic Asthma
Keywords: asthma
omalizumab
allergy
IgE
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 300
Sex: ALL
Minimum age (years): 14
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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.)

Primary outcomes:
measure: Change in Asthma Control Test (ACT)
timeFrame: Baseline, up to16weeks，24weeks and 1year of treatment.
measure: Global Evaluation of Treatment Effectiveness (GETE)
timeFrame: Baseline, up to16weeks，24weeks and 1year of treatment.
Secondary outcomes:
measure: Forced Expiratory Volume in 1 second（FEV1)
timeFrame: Baseline, up to 16weeks，24weeks and 1year of treatment.
measure: FEV1/predicted%.
timeFrame: Baseline, up to 16weeks，24weeks and 1year of treatment.
measure: Forced Vital Capacity （FVC）
timeFrame: Baseline, up to16weeks，24weeks and 1year of treatment.
measure: FEV1/FVC.
timeFrame: Baseline, up to16weeks，24weeks and 1year of treatment.
measure: Number of Acute Exacerbations（AE）
timeFrame: up to16weeks，24weeks and 1year of treatment.
measure: Oral glucocorticoid dosage
timeFrame: up to16weeks，24weeks and 1year of treatment.
measure: Good adherence
timeFrame: 1 year
measure: Poor adherence
timeFrame: 1 year
measure: Adverse events
timeFrame: up to16weeks，24weeks and 1year of treatment.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Linfu zhou
state: Jiangsu
Study officials:
References: