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临床试验/NCT07452380
NCT07452380招募中不适用

A Multicenter Registry Study Examining the Efficacy of Specific Immunotherapy Guided by Component-Resolved Diagnosis for Dust Mite Allergens in Chinese Pediatric Patients With Rhinitis and/or Asthma(EXPLORER STUDY)

The Children's Hospital of Zhejiang University School of Medicine1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年11月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
1
主要终点
The Changes of CSMS

研究概览

简要总结

This study is a Study to Understand How to Better Match Allergy Shots to a Child's Unique Mite Allergy Profile

  1. Why is this study being done? For many children, tiny house dust mites are a major cause of persistent allergies, leading to uncomfortable symptoms like a stuffy nose, sneezing, and even asthma. A common long-term treatment is allergy shots, also known as allergen immunotherapy (AIT). These shots work like a vaccine, slowly training the body's immune system to stop overreacting to mites. However, not every child responds to this treatment in the same way. The investigators now know that children can be allergic to different parts of the dust mite. While most treatments focus on the most common parts (called "major allergens"), some children are allergic to other, less common parts (called "intermediate or minor allergens").

The EXPLORER study wants to find out if a child's unique allergy profile-meaning which specific mite proteins they are allergic to-affects how well they respond to allergy shots. Our goal is to move away from a "one-size-fits-all" approach and toward more personalized care for children with dust mite allergies. 2. Who is this study for? The investigators are looking for children and teenagers (ages 5 to 18) in China who have a confirmed dust mite allergy and are planning to start allergy shots. 3. What will happen during the study? This is an "observational" study, which means the investigators will simply observe and track the progress of children who are already receiving a standard, approved allergy shot treatment as part of their regular medical care. The investigators won't be testing a new drug.

Here's what participation involves:

A Detailed Allergy Test: At the beginning, participants will have a special blood test. This test will look for allergies to nine different specific parts of the dust mite, giving us a very detailed map of their allergy.

Grouping: Based on the results of this test, participants will be placed into different groups according to their specific allergy patterns.

Tracking Progress: The investigators will follow their treatment journey for three years. The investigators will collect information at regular check-ups (at 0, 3, 6, 12, 24, and 36 months) on:

How well their symptoms are controlled. How much allergy medication they need. Their overall quality of life. Any side effects from the shots. Annual Blood Tests: Once a year, the investigators will repeat the detailed blood test to see how their immune system is changing in response to the treatment. 4. What do the investigators hope to learn? The investigators have a main theory, or hypothesis: Children who are allergic to many different parts of the dust mite (including the minor ones) will show greater improvement from the allergy shots, compared to children who are only allergic to the most common parts.

By studying a large group of 1,000 children, the investigators hope to provide clear evidence that can help doctors choose the right treatment for the right child. This will help fill a current gap in medical guidelines and bring us closer to truly personalized treatment for pediatric allergies. 5. Why is this study important? This is the first large-scale study of its kind in a real-world setting. The results could change how doctors diagnose and treat dust mite allergies in children. Instead of just knowing a child is allergic to mites, the investigators will be able to see the full picture of how they are allergic. This knowledge will help ensure that every child receives the treatment that gives them the best chance for long-term relief.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • (1) Age: 5 years ≤ age < 18 years; (2) 1) Allergic rhinitis caused by Dermatophagoides pteronyssinus and/or Dermatophagoides farinae; 2) Or serum specific IgE ≥ 0.70 (kU/L) (for D. pteronyssinus and/or D. farinae); (3) Children meeting criteria (2) must undergo allergen component testing; (4) If accompanied by bronchial asthma, asthma must be diagnosed according to the Guidelines for the Diagnosis and Prevention of Childhood Bronchial Asthma (2025 edition) and the patient's asthma symptoms must be confirmed as well-controlled.
  • (5) Receiving treatment with dual-mite (Dermatophagoides pteronyssinus and farinae) subcutaneous immunotherapy (SCIT).

排除标准

  • (1) Participants and/or their parents/legal guardians are judged by the investigator to be unable to fully understand the study requirements, or to adhere to long-term treatment and identify adverse reactions (including but not limited to conditions such as cognitive impairment or mental illness); (2) Children with severe or uncontrolled asthma (FEV1 < 70% of predicted value) or with irreversible airflow obstruction; (3) Children using beta-blockers or angiotensin-converting enzyme inhibitors (ACEI); (4) Children with severe autoimmune diseases or immunodeficiencies, including AIDS, inflammatory bowel disease, etc., as well as those currently using immunosuppressants; (5) Children with severe cardiovascular diseases or malignant tumors; (6) Children with incomplete clinical data.

研究组 & 干预措施

major allergens group

The group containing only major allergen components detected by Component-Resolved Diagnosis

intermediate/minor allergens group

The group containing intermediate/minor allergens with or without major components.

结局指标

主要结局

The Changes of CSMS

时间窗: evaluated at months 3, 6, 12, 24, and 36

the change from baseline in Combined Symptom and Medication Scores (CSMS). CSMS includes a symptom score and a medication score. The minimum value for the symptom score is 0 and the maximum is 3. The minimum value for the medication score is 0 and the maximum is 3. The combined score is the sum of these two scores, with a higher score indicating more severe symptoms.

次要结局

  • serological markers(at years 1, 2, and 3)
  • Visual Analog Scale (VAS) scores(evaluated at months 3, 6, 12, 24, and 36)

研究者

发起方
The Children's Hospital of Zhejiang University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

TANG LANFANG

Director of the Pulmonology Department of The Children's Hospital of Zhejiang University School of Medicine

The Children's Hospital of Zhejiang University School of Medicine

研究点 (1)

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