Clinical trials / NCT07452380
Recruiting

The Efficacy of Specific Immunotherapy Guided by Component-Resolved Diagnosis for Dust Mite Allergens in Chinese Pediatric Patients With Rhinitis and/or Asthma

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…

ClinicalTrials.gov IDNCT07452380
PhaseNot Applicable
Enrollment1000
SponsorThe Children's Hospital of Zhejiang University School of Medicine
Age5 Years
SexALL
I'm interested View official listing

Conditions studied

Allergic Rhinitis Due to House Dust Mite

About this study

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…

Primary outcomes

Eligibility information

Inclusion Criteria: -(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). Exclusion Criteria: * (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.

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.