An observational study in Allergic Rhinitis Due to House Dust Mite, sponsored by The Children's Hospital of Zhejiang University School of Medicine. Recruiting at 1 site in China. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-03-09.
Sponsored by The Children's Hospital of Zhejiang University School of Medicine · Observational
This study is a Study to Understand How to Better Match Allergy Shots to a Child's Unique Mite Allergy Profile
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.
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.
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.
717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 120 across 143 observational studies indexed under Rhinitis, Allergic.
Browse Rhinitis, Allergic studies →The Children's Hospital of Zhejiang University School of Medicine is the lead sponsor of 69 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
-(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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The group containing only major allergen components detected by Component-Resolved Diagnosis
The group containing intermediate/minor allergens with or without major components.
The Changes of CSMS
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.
Time frame: evaluated at months 3, 6, 12, 24, and 36
serological markers
sIgE/sIgG4 ratios of HDM components
Time frame: at years 1, 2, and 3
Visual Analog Scale (VAS) scores
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.
Time frame: evaluated at months 3, 6, 12, 24, and 36
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — 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.
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The Children's Hospital of Zhejiang University School of Medicine