Allergic AsthmaNCT06771934
Combination Therapy of Omalizumab and Allergen Immunotherapy for Moderate to Severe Asthma
An observational study of Allergic Asthma, run by Qianfoshan Hospital at 1 site in China.
Trial summary
The combined treatment of anti-IgE monoclonal antibody and standardized allergen immunotherapy has good efficacy and safety in allergic diseases. However, the efficacy and safety of the combined treatment for allergic asthma in the Chinese population have not been fully elucidated yet.This study is a prospective… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- Allergen-specific immunotherapy(AIT) and omalizumab
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 30 Jun 2025
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of patients with moderate to severe allergic asthma who are aged 6 years or older in the Chinese population, have dust mites as the main allergens, and are receiving standardized allergen-specific immunotherapy or omalizumab combined with standardized allergen-specific immunotherapy in our hospital
Who may be able to join
- Individuals who meet all of the following criteria are eligible for enrollment as study participants:
- Chinese patients,aged 6 years and older，female or male
- Diagnosed as allergic asthma according to the guideline for Chinese guidelines for the diagnosis and treatment of allergic asthma（2019，the first edition）
- Meet the diagnostic criteria for moderate and severe asthma, in line with the diagnostic standards of the GINA (Global Initiative for Asthma)，it refers to those who can achieve complete control under the GINA Step 3 treatment; for severe asthma, it refers to those who need Step 4 or Step 5 treatment to achieve complete control, or those who still cannot achieve control even after undergoing Step 4 or Step 5 treatment.
- The patients included in the study were positive for specific immunoglobulin E (sIgE), or had a positive skin prick test (SPT) with D.pteronyssinus and D. farinae allergens.
- Patients who will initiate AIT or omalizumab combined with AIT according to real life clinical standards of practice.
Who cannot join
- Individuals who meet any of the following criteria are not eligible for enrollment as study participants:
- Uncontrolled asthma or forced expiratory volume in one second (FEV1) is lower than 70% of the predicted value.
- Currently receiving treatment of beta blockers or angiotensin converting enzyme inhibitor (ACEI) 3．With severe or uncontrolled cardio-cerebral vascular, hepatic, renal, gastrointestinal, hematopoietic，genitourinary, endocrine, nervous and immunological medical conditions, or other conditions that investigators think the patient not suitable for this study.
- 4．Pregnant or planning pregnancy.
Trial locations and contacts
1 site in 1 country.
China1 site
Shandong Provincial Qianfoshan Hospital,The First Affliated Hospital of Shandong First Medical University
Jinan, Shandong, 250014
About this study
Official title: Efficacy and Safety Evaluation of Omalizumab Combined With Standardized Allergen Specific Immunotherapy in Moderate to Severe Allergic Asthma
The combined treatment of anti-IgE monoclonal antibody and standardized allergen immunotherapy has good efficacy and safety in allergic diseases. However, the efficacy and safety of the combined treatment for allergic asthma in the Chinese population have not been fully elucidated yet.This study is a prospective observational study designed to evaluate the efficacy and safety of omalizumab combined with allergen immunotherapy (AIT) in patients with moderate to severe asthma in the Chinese population.
- Conditions
- Allergic Asthma
- Being tested
- Allergen-specific immunotherapy(AIT), omalizumab
- Keywords
- Allergic Asthma, IgE, immunotherapy, omalizumab
- Medical subject headings
- Epilepsy, Idiopathic Generalized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergen-specific immunotherapy(AIT)Biological
Allergen-Specific Immunotherapy(AIT) Protocol: using the house dust mite allergen preparation (Alutard, ALK Company, Denmark). The treatment course was divided into the initial treatment stage and the maintenance treatment stage. The initial treatment stage, also known as the dose accumulation stage, involved injecting the vaccine once a week and usually lasted for 15 weeks. For highly sensitive patients, treatment was carried out according to the dose guidelines for "high sensitivity". The maximum dose in the initial treatment stage was the maintenance dose. After reaching the maintenance dose, the first maintenance injection was given 2 weeks later, the second maintenance injection was given 4 weeks later, and thereafter, a vaccine injection was carried out every 4 - 8 weeks.
omalizumabBiological
Omalizumab Treatment Protocol: The dosage and administration frequency (once every 2 weeks or once every 4 weeks) of omalizumab were determined based on the patients' pretreatment serum total IgE (kU/L), age, and body weight (kg). Each dosage ranged from 15 to 600 mg and was administered subcutaneously. If the dosage was ≤ 150 mg, it was injected subcutaneously at 1 site; otherwise, it was injected subcutaneously at 1 to 4 sites respectively. After the first 3 injections, patients were observed in the hospital for at least 2 hours, and after the 4th and subsequent injections, they were observed for at least 30 minutes. During the treatment period, the background medications for asthma control were adjusted according to the patient's condition.
| Study group | Role | What they receive |
|---|---|---|
| Allergen-specific immunotherapy alone group (AIT alone group) | Patients start to receive allergen-specific immunotherapy 1 to 3 months after asthma is under control. Receives: Biological: Allergen-specific immunotherapy(AIT) | |
| the omalizumab combined with allergen-specific immunotherapy group | Omalizumab treatment was administered 4 to 8 weeks before the initiation of standardized allergen-specific immunotherapy. After the initiation of standardized allergen-specific immunotherapy, the overlapping treatment with allergen-specific immunotherapy (AIT) and omalizumab was continued. Receives: Biological: Allergen-specific immunotherapy(AIT); Biological: omalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence rate of adverse reactions in standardized allergen immunotherapy
Adverse reactions of allergen immunotherapy (AIT) can be divided into local adverse reactions and systemic adverse reactions according to the occurrence sites. Local adverse reactions mainly include itching, redness, swelling, induration and even necrosis at the allergen injection sites. Systemic adverse reactions of AIT include cough, dyspnea, urticaria, asthma attacks and so on, and can lead to anaphylactic shock in severe cases.In this study, the incidence rates of adverse reactions in the two groups of patients were taken as the main research indicators to evaluate the role of omalizumab in the process of desensitization treatment.
Measured: The observation time of this study is one year, starting from the time when the patient begins AIT therapy and followed up for one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start1 Jun 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic AsthmaStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lili Zhi, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771934
- Sponsor's protocol ID
- YXLL-KY-2024(061)
- Status last verified
- Jun 2024
- First submitted
- 7 Jan 2025
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of Omalizumab Combined With Standardized Allergen Specific Immunotherapy in Moderate to Severe Allergic Asthma
- ClinicalTrials.gov ID
- NCT06771934
- Acronym / sponsor ID
- YXLL-KY-2024(061)
- Conditions
- Allergic Asthma
- Keywords
- Allergic Asthma, IgE, immunotherapy, omalizumab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 13 Jan 2025 (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.
The combined treatment of anti-IgE monoclonal antibody and standardized allergen immunotherapy has good efficacy and safety in allergic diseases. However, the efficacy and safety of the combined treatment for allergic asthma in the Chinese population have not been fully elucidated yet.This study is a prospective observational study designed to evaluate the efficacy and safety of omalizumab combined with allergen immunotherapy (AIT) in patients with moderate to severe asthma in the Chinese population.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allergen-specific immunotherapy alone group (AIT alone group) | – | Biological: Allergen-specific immunotherapy(AIT)Patients start to receive allergen-specific immunotherapy 1 to 3 months after asthma is under control. |
| the omalizumab combined with allergen-specific immunotherapy group | – | Biological: Allergen-specific immunotherapy(AIT), Biological: omalizumabOmalizumab treatment was administered 4 to 8 weeks before the initiation of standardized allergen-specific immunotherapy. After the initiation of standardized allergen-specific immunotherapy, the overlapping treatment with allergen-specific immunotherapy (AIT) and omalizumab was continued. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of patients with moderate to severe allergic asthma who are aged 6 years or older in the Chinese population, have dust mites as the main allergens, and are receiving standardized allergen-specific immunotherapy or omalizumab combined with standardized allergen-specific immunotherapy in our hospital
Key inclusion criteria (6 listed)
- Individuals who meet all of the following criteria are eligible for enrollment as study participants:
- Chinese patients,aged 6 years and older，female or male
- Diagnosed as allergic asthma according to the guideline for Chinese guidelines for the diagnosis and treatment of allergic asthma（2019，the first edition）
- Meet the diagnostic criteria for moderate and severe asthma, in line with the diagnostic standards of the GINA (Global Initiative for Asthma)，it refers to those who can achieve complete control under the GINA Step 3 treatment; for severe asthma, it refers to those who need Step 4 or Step 5 treatment to achieve complete control, or those who still cannot achieve control even after undergoing Step 4 or Step 5 treatment.
- The patients included in the study were positive for specific immunoglobulin E (sIgE), or had a positive skin prick test (SPT) with D.pteronyssinus and D. farinae allergens.
Key exclusion criteria (4 listed)
- Individuals who meet any of the following criteria are not eligible for enrollment as study participants:
- Uncontrolled asthma or forced expiratory volume in one second (FEV1) is lower than 70% of the predicted value.
- Currently receiving treatment of beta blockers or angiotensin converting enzyme inhibitor (ACEI) 3．With severe or uncontrolled cardio-cerebral vascular, hepatic, renal, gastrointestinal, hematopoietic，genitourinary, endocrine, nervous and immunological medical conditions, or other conditions that investigators think the patient not suitable for this study.
- 4．Pregnant or planning pregnancy.
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 |
|---|---|---|
| Allergen-specific immunotherapy(AIT)Allergen-Specific Immunotherapy(AIT) Protocol: using the house dust mite allergen preparation (Alutard, ALK Company, Denmark). The treatment course was divided into the initial treatment stage and the maintenance treatment stage. The initial treatment stage, also known as the dose accumulation stage, involved injecting the vaccine once a week and usually lasted for 15 weeks. For highly sensitive patients, treatment was carried out according to the dose guidelines for "high sensitivity". The maximum dose in the initial treatment stage was the maintenance dose. After reaching the maintenance dose, the first maintenance injection was given 2 weeks later, the second maintenance injection was given 4 weeks later, and thereafter, a vaccine injection was carried out every 4 - 8 weeks. | Biological | Allergen-specific immunotherapy alone group (AIT alone group), the omalizumab combined with allergen-specific immunotherapy group |
| omalizumabOmalizumab Treatment Protocol: The dosage and administration frequency (once every 2 weeks or once every 4 weeks) of omalizumab were determined based on the patients' pretreatment serum total IgE (kU/L), age, and body weight (kg). Each dosage ranged from 15 to 600 mg and was administered subcutaneously. If the dosage was ≤ 150 mg, it was injected subcutaneously at 1 site; otherwise, it was injected subcutaneously at 1 to 4 sites respectively. After the first 3 injections, patients were observed in the hospital for at least 2 hours, and after the 4th and subsequent injections, they were observed for at least 30 minutes. During the treatment period, the background medications for asthma control were adjusted according to the patient's condition. | Biological | the omalizumab combined with allergen-specific immunotherapy group |
Primary outcome
the incidence rate of adverse reactions in standardized allergen immunotherapy
Time frame: The observation time of this study is one year, starting from the time when the patient begins AIT therapy and followed up for one year.
Adverse reactions of allergen immunotherapy (AIT) can be divided into local adverse reactions and systemic adverse reactions according to the occurrence sites. Local adverse reactions mainly include itching, redness, swelling, induration and even necrosis at the allergen injection sites. Systemic adverse reactions of AIT include cough, dyspnea, urticaria, asthma attacks and so on, and can lead to anaphylactic shock in severe cases.In this study, the incidence rates of adverse reactions in the two groups of patients were taken as the main research indicators to evaluate the role of omalizumab in the process of desensitization treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Allergic Asthma, run by Qianfoshan Hospital 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 6 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 13 Jan 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence rate of adverse reactions in standardized allergen immunotherapy (time frame: The observation time of this study is one year, starting from the time when the patient begins AIT therapy and followed up for one year.). 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 13 Jan 2025.