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

March 5, 2026 updated by: TANG LANFANG, The Children's Hospital of Zhejiang University School of Medicine

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）

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The Children's Hospital of Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This study plans to recruit participants from multiple research centers across China between November 2025 and November 2028. The target population is children aged 5 to 18 years who have been confirmed as having dust mite allergy through allergen testing and are scheduled to receive subcutaneous specific immunotherapy with a dust mite dual-allergen preparation.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Changes of CSMS
Time Frame: 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.
evaluated at months 3, 6, 12, 24, and 36

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serological markers
Time Frame: at years 1, 2, and 3
sIgE/sIgG4 ratios of HDM components
at years 1, 2, and 3
Visual Analog Scale (VAS) scores
Time Frame: evaluated at months 3, 6, 12, 24, and 36
the change from baseline in Visual Analog Scale (VAS) scores. The minimum value for the VAS is 0 and the maximum is 10, with a higher score indicating more severe symptoms.
evaluated at months 3, 6, 12, 24, and 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Children's Hospital of Zhejiang University School of Medicine

Investigators

  • Study Director: Lanfang Tang, PhD, The Children's Hospital of Zhejiang University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

March 1, 2026

First Submitted That Met QC Criteria

March 1, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-IRB-0386-P-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

In the EDC system, only the data entry personnel at the principal investigator's site and sub-centers are permitted to input data, and only the data monitoring personnel are permitted to view it.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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