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

NCT07452380 | Recruiting DMC

• 1 other identifier: 2025-IRB-0386-P-01
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 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").
2. 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. 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.
4. 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.
5. 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.

Conditions

Allergic Rhinitis Due to House Dust Mite

Keywords

House dust mite; allergic rhinitis; Component-Resolved Diagnosis; Allergen Immunotherapy; subcutaneous immunotherapy; asthma

Outcome Measures

Primary Outcomes (1)

• 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.

  evaluated at months 3, 6, 12, 24, and 36

Secondary Outcomes (2)

• serological markers

  at years 1, 2, and 3

• Visual Analog Scale (VAS) scores

  evaluated at months 3, 6, 12, 24, and 36

Study Arms (2)

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.

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• (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).

You may not qualify if:

• (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.

Sponsors & Collaborators

• The Children's Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

The Children's Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

Related Publications (9)

• Schuster A, Caimmi D, Nolte H, Novakova S, Mikler J, Foss-Skiftesvik MH, Osterdal AS, Emeryk A, Gagnon R, Pfaar O. Efficacy and safety of SQ house dust mite sublingual immunotherapy-tablet (12 SQ-HDM) in children with allergic rhinitis/rhinoconjunctivitis with or without asthma (MT-12): a randomised, double-blind, placebo-controlled, phase III trial. Lancet Reg Health Eur. 2024 Nov 26;48:101136. doi: 10.1016/j.lanepe.2024.101136. eCollection 2025 Jan.

  PMID: 39678704 BACKGROUND

• Rodriguez-Dominguez A, Berings M, Rohrbach A, Huang HJ, Curin M, Gevaert P, Matricardi PM, Valenta R, Vrtala S. Molecular profiling of allergen-specific antibody responses may enhance success of specific immunotherapy. J Allergy Clin Immunol. 2020 Nov;146(5):1097-1108. doi: 10.1016/j.jaci.2020.03.029. Epub 2020 Apr 13.

  PMID: 32298697 BACKGROUND

• Gan H, Luo W, Huang Z, Zhang T, Hou X, Chen Y, Zhu Z, Sun B. House dust mite components sensitization profile in China, a multi-centre study. Clin Exp Allergy. 2023 Feb;53(2):226-229. doi: 10.1111/cea.14255. Epub 2022 Dec 15. No abstract available.

  PMID: 36519672 BACKGROUND

• Chen KW, Zieglmayer P, Zieglmayer R, Lemell P, Horak F, Bunu CP, Valenta R, Vrtala S. Selection of house dust mite-allergic patients by molecular diagnosis may enhance success of specific immunotherapy. J Allergy Clin Immunol. 2019 Mar;143(3):1248-1252.e12. doi: 10.1016/j.jaci.2018.10.048. Epub 2018 Nov 14. No abstract available.

  PMID: 30445063 BACKGROUND

• Luo W, Chen H, Cheng L, Cui Y, Guo Y, Gao Z, Guan K, Han K, Hong H, Ji K, Li J, Liu G, Meng J, Sun JL, Tao A, Tang W, Wang H, Wang X, Wei J, Shao X, Xiang L, Tsui SK, Zhang H, Yu Y, Zhao L, Huang Z, Gan H, Zhang J, Zheng X, Zheng P, Huang H, Hao C, Zhu R, Sun B. Chinese expert consensus on allergen component resolved diagnosis. Pediatr Allergy Immunol. 2024 Nov;35(11):e14272. doi: 10.1111/pai.14272.

  PMID: 39503267 BACKGROUND

• Xu Q, Zhou Q, Chen J, Li T, Ma J, Du R, Su M, Li J, Xu M, Sun S, Ma J, Ramanathan M Jr, Zhang Z. The incidence of asthma attributable to temperature variability: An ecological study based on 1990-2019 GBD data. Sci Total Environ. 2023 Dec 15;904:166726. doi: 10.1016/j.scitotenv.2023.166726. Epub 2023 Sep 1.

  PMID: 37659541 BACKGROUND

• Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2.

  PMID: 35691614 BACKGROUND

• Venkatesan P. 2023 GINA report for asthma. Lancet Respir Med. 2023 Jul;11(7):589. doi: 10.1016/S2213-2600(23)00230-8. Epub 2023 Jun 8. No abstract available.

  PMID: 37302397 BACKGROUND

• Hao Y, Yang Y, Zhao H, Chen Y, Zuo T, Zhang Y, Yu H, Cui L, Song X. Multi-omics in Allergic Rhinitis: Mechanism Dissection and Precision Medicine. Clin Rev Allergy Immunol. 2025 Feb 18;68(1):19. doi: 10.1007/s12016-025-09028-3.

  PMID: 39964644 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Rhinitis, Allergic; Asthma

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Lanfang Tang, PhD

  The Children's Hospital of Zhejiang University School of Medicine

  STUDY DIRECTOR

Central Study Contacts

Yujia Xiao, PhD

CONTACT

86+13397813805; 6195007@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Pulmonology Department of The Children's Hospital of Zhejiang University School of Medicine

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: March 5, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)