UnknownNot Applicable

Combination Therapy of Omalizumab and Allergen Immunotherapy for Moderate to Severe Asthma

China60 participantsStarted 2024-06-01

Plain-language 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 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.

Who can participate

Age range

6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

the incidence rate of adverse reactions in standardized allergen immunotherapy

Timeframe: 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.

Trial details

NCT IDNCT06771934

SponsorQianfoshan Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06-30

View on ClinicalTrials.gov More Allergic Asthma trials

Plain-language summary

Who can participate

Age range

6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Combination Therapy of Omalizumab and Allergen Immunotherapy for Moderate to Severe Asthma

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Combination Therapy of Omalizumab and Allergen Immunotherapy for Moderate to Severe Asthma

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria