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

March 28, 2024 updated by: The First Affiliated Hospital with Nanjing Medical University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Asthma Control Test (ACT)
Time Frame: Baseline, up to16weeks，24weeks and 1year of treatment.
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)
Time Frame: Baseline, up to16weeks，24weeks and 1year of treatment.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Forced Expiratory Volume in 1 second（FEV1)
Time Frame: Baseline, up to 16weeks，24weeks and 1year of treatment.
Pre-bronchodilators FEV1 .
Baseline, up to 16weeks，24weeks and 1year of treatment.
FEV1/predicted%.
Time Frame: Baseline, up to 16weeks，24weeks and 1year of treatment.
Pre-bronchodilators FEV1/predicted%.
Baseline, up to 16weeks，24weeks and 1year of treatment.
Forced Vital Capacity （FVC）
Time Frame: Baseline, up to16weeks，24weeks and 1year of treatment.
Pre-bronchodilators FVC
Baseline, up to16weeks，24weeks and 1year of treatment.
FEV1/FVC.
Time Frame: Baseline, up to16weeks，24weeks and 1year of treatment.
Pre-bronchodilators FEV1/FVC.
Baseline, up to16weeks，24weeks and 1year of treatment.
Number of Acute Exacerbations（AE）
Time Frame: up to16weeks，24weeks and 1year of treatment.
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
Time Frame: up to16weeks，24weeks and 1year of treatment.
Oral glucocorticoid dosage before and after omalizumab treatment
up to16weeks，24weeks and 1year of treatment.
Good adherence
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: up to16weeks，24weeks and 1year of treatment.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Moderate to Severe Allergic Asthma

Clinical Trials on IgE monoclonal antibody

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings