Moderate to Severe Allergic AsthmaESSENCENCT06348407
A Clinical Study of Omalizumab in the Treatment of Allergic Asthma(ESSENCE)
An observational study of Moderate to Severe Allergic Asthma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 14 to 90 years
- Conditions the study is for
- Moderate to Severe Allergic Asthma
- What is being tested?
- IgE monoclonal antibody
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 30 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Linfu zhou
Nanjing, Jiangsu, 210000
Xuejun Zhang, Master, 86+13704726254, zxj1301@163.com
About this study
Official title: 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.
- Conditions
- Moderate to Severe Allergic Asthma
- Being tested
- IgE monoclonal antibody
- Keywords
- asthma, omalizumab, allergy, IgE
- Medical subject headings
- Asthma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IgE monoclonal antibodyDrug
omalizumab
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: IgE monoclonal antibody | |
| No-Responder group | The improvement in ACT score < 3;The GETE score was moderate,poor and worse. Receives: 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. Receives: 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. Receives: Drug: IgE monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baseline, up to16weeks，24weeks and 1year of treatment.
Secondary outcomes (9)
Forced Expiratory Volume in 1 second（FEV1)
Pre-bronchodilators FEV1 .
Measured: Baseline, up to 16weeks，24weeks and 1year of treatment.
FEV1/predicted%.
Pre-bronchodilators FEV1/predicted%.
Measured: Baseline, up to 16weeks，24weeks and 1year of treatment.
Forced Vital Capacity （FVC）
Pre-bronchodilators FVC
Measured: Baseline, up to16weeks，24weeks and 1year of treatment.
FEV1/FVC.
Pre-bronchodilators FEV1/FVC.
Measured: Baseline, up to16weeks，24weeks and 1year of treatment.
Number of Acute Exacerbations（AE）
Number of acute exacerbations 1 year before omalizumab treatment,and up to16weeks，24weeks and 1year of treatment.
Measured: up to16weeks，24weeks and 1year of treatment.
Oral glucocorticoid dosage
Oral glucocorticoid dosage before and after omalizumab treatment
Measured: up to16weeks，24weeks and 1year of treatment.
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.
Measured: 1 year
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.
Measured: 1 year
Adverse events
Incidence of adverse events = Number of subjects with adverse events/Total number of subjects in treatment×100%
Measured: up to16weeks，24weeks and 1year of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start1 Dec 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Allergic AsthmaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348407
- Sponsor's protocol ID
- 2024-BA-001
- Acronym
- ESSENCE
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Protect patient privacy
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Omalizumab in the Treatment of Moderate to Severe Allergic Asthma:A Retrospective Single-center Clinical Trial
- ClinicalTrials.gov ID
- NCT06348407
- Acronym / sponsor ID
- ESSENCE / 2024-BA-001
- Conditions
- Moderate to Severe Allergic Asthma
- Keywords
- asthma, omalizumab, allergy, IgE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Responder group | – | Drug: IgE monoclonal antibodyThe 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 | – | Drug: IgE monoclonal antibodyThe improvement in ACT score < 3;The GETE score was moderate,poor and worse. |
| Good adherence | – | Drug: IgE monoclonal antibodyThe 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 | – | Drug: IgE monoclonal antibodythe proportion of patients who missed at least 10% of all doses over the 1year,we think these patients were poor adherence. |
Who may qualify
- Ages
- 14 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IgE monoclonal antibodyomalizumab | Drug | Good adherence, No-Responder group, Poor adherence, Responder group |
Primary outcome
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).
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.
9 secondary outcomes
Forced Expiratory Volume in 1 second（FEV1)
Time frame: Baseline, up to 16weeks，24weeks and 1year of treatment.
FEV1/predicted%.
Time frame: Baseline, up to 16weeks，24weeks and 1year of treatment.
Forced Vital Capacity （FVC）
Time frame: Baseline, up to16weeks，24weeks and 1year of treatment.
FEV1/FVC.
Time frame: Baseline, up to16weeks，24weeks and 1year of treatment.
Number of Acute Exacerbations（AE）
Time frame: up to16weeks，24weeks and 1year of treatment.
Oral glucocorticoid dosage
Time frame: up to16weeks，24weeks and 1year of treatment.
Good adherence
Time frame: 1 year
Poor adherence
Time frame: 1 year
Adverse events
Time frame: up to16weeks，24weeks and 1year of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: No. Protect patient privacy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moderate to Severe Allergic Asthma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linfu Zhou, Doctor (86+13611573618, linfu.zhou@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Asthma Control Test (ACT) (time frame: Baseline, up to16weeks，24weeks and 1year of treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.