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）
Conditions: Allergic Rhinitis Due to House Dust Mite
Sponsor: 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）
Research Proposal
NCT：____________________
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Research
Institution
The Children's Hospital of Zhejiang University
School of Medicine
Research
Department
Pulmonology Department
Project Source
Investigator-Initiated Research

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1. Research Background
Allergic Rhinitis (AR) is an IgE-mediated inflammation of the nasal mucosa and
one of the most common allergic diseases in children. Its global prevalence continues
to rise, particularly in industrialized nations and rapidly urbanizing areas, affecting
approximately 10%-40% of the population worldwide (reaching up to 50% in some
regions). AR significantly impairs the quality of life in affected children and
frequently coexists with other conditions such as asthma, establishing it as one of the
most prevalent chronic diseases [1]. Asthma is the most common chronic
inflammatory airway disease globally, affecting about 10-15% of children worldwide
[2] and ranking as the second leading cause of death among chronic respiratory
diseases. Allergic Asthma (AA) is the most predominant subtype in children
(accounting for 80% of childhood asthma cases), characterized by airway
inflammation and structural remodeling. This leads to airway hyperresponsiveness
and reversible airflow limitation, manifesting as dyspnea, wheezing, and coughing,
often accompanied by conditions like AR, and severely impacting quality of life [3].
Although the implementation of asthma management and prevention strategies has
somewhat reduced prevalence and mortality rates, the absolute number of asthma
cases is still rising due to population growth [4].
House Dust Mites (HDM) are among the most significant indoor allergens
worldwide, closely linked to allergic diseases such as AR, AA, and atopic dermatitis.
The primary HDM species are Dermatophagoides pteronyssinus and
Dermatophagoides farinae, which are widely distributed in human living
environments. HDM are complex mixtures composed of various proteins, referred to
as "components." As of 2025, the WHO/IUIS has officially named 39 HDM allergen
components (Der p/f numbering system). Among these, Der p 1, Der p 2, Der f 1, Der
f 2, and Der p 23 are considered major components, serving as core sensitizing
allergens. Most HDM-allergic children (>50%) are sensitive to these major
components, which are strongly correlated with clinical symptoms (e.g., asthma,
rhinitis) and are primary targets for specific immunotherapy [5, 6]. Intermediate
components exhibit sensitization rates of 25–50% and may become predominant
sensitizers in specific populations or regions. They can potentially exacerbate allergic
symptoms, and some are associated with cross-reactivity, but they are not core

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therapeutic targets. Minor components have sensitization rates <25%; they are often
cross-reactive proteins that do not directly cause HDM allergy symptoms or only
sensitize individuals in specific populations. Furthermore, the sensitization
characteristics of HDM components vary significantly across different geographical
regions within China [7]. Component-Resolved Diagnostics (CRD) is a more precise
allergy diagnostic method. It uses natural or recombinant single-component allergens
to identify the specific molecules causing the allergy. By detecting specific IgE (sIgE)
antibodies against individual allergen components, CRD helps distinguish between
genuine sensitization and cross-reactivity, such as differentiating co-sensitization
(where specific components from two or more different allergen sources are
recognized by distinct sIgE antibodies) from cross-sensitization (where structurally
similar allergen components from multiple sources are recognized by the same sIgE
antibodies), thereby improving diagnostic accuracy [5].
Allergen Immunotherapy (AIT), also known as desensitization therapy, is a
causative treatment for allergic diseases. It works by gradually exposing the patient to
the allergen, inducing immune tolerance, and thereby reducing or eliminating allergic
symptoms. AIT is indicated for patients with clearly identified and unavoidable
allergens (e.g., dust mites, pollen), those with poor symptom control on
pharmacotherapy or requiring long-term medication, and those unwilling to use
long-term medication. AIT is currently the only treatment modality with the potential
to alter the natural course of allergic diseases, although it requires careful patient
selection and long-term adherence [8]. Prior to initiating AIT, the causative allergen
must be clearly identified through skin prick tests or sIgE detection. When indications
are met, AIT can significantly enhance quality of life and reduce long-term
complications [9].
Preliminary studies by our group have revealed that most children are sensitized
to multiple HDM components simultaneously, including not only major components
but also intermediate and minor ones. Current guidelines do not provide clear
recommendations on whether specific immunotherapy should be administered to
children sensitized exclusively to intermediate and minor components. Furthermore,
there is a lack of national data on the efficacy and long-term follow-up outcomes of
specific immunotherapy in children with HDM allergy.
This study aims to systematically collect and analyze real-world data from
HDM-positive children undergoing AIT nationwide. We will evaluate the differential

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efficacy and long-term benefits of AIT among children with different sensitization
profiles (major, intermediate, and minor components). The ultimate goal is to provide
evidence-based support and decision-making guidance for the development of precise
and personalized clinical protocols for HDM AIT.
2. Research Objectives
To observe the differences in efficacy of AIT among children with different
sensitization profiles through CRD for house dust mites in children with AR with or
without concomitant AA. The study will focus on evaluating the clinical benefits of
AIT specifically for children sensitized to intermediate and minor components,
thereby providing an evidence-based foundation for establishing precise AIT
strategies guided by CRD.
3.
Research Methods
3.1 This study is a multicenter observational registry study, with a planned enrollment
of 1,000 cases. Our institution serves as the lead research unit, with multiple clinical
centers across the country participating. All children meeting the inclusion and
exclusion criteria will receive AIT for a full 3 years. Each research center will recruit
eligible subjects according to the inclusion and exclusion criteria and obtain signed
informed consent forms (applicable to prospective studies). Relevant clinical
information will be collected according to the prospective research plan. This registry
study does not involve any intervention; it only collects relevant clinical information.
All diagnosis and treatment decisions are made by the clinicians. Clinicians may
provide appropriate treatment based on the specific conditions of the children.
3.2 Sample Size Estimation
The planned enrollment is 1,000 cases, with 50-100 cases per center. Descriptive
and exploratory analyses will be performed on the data; no statistical hypotheses have
been formulated. In general, quantitative variables will be summarized using the
following descriptive statistics: number of cases, mean, standard deviation, median,
Q1, Q3, minimum, and maximum. Qualitative variables will be summarized by the

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number and percentage of children in each category. This study will calculate changes
in VAS scores and medication scores before and after treatment, as well as the
incidence of adverse reactions, rates of new sensitization, rates of new-onset asthma,
and treatment adherence. Differences among subgroups with different component
sensitization profiles will be compared, and related influencing factors will be
analyzed.
4. Study Subjects
This study plans to enroll children aged 5 to 18 years who undergo subcutaneous
specific immunotherapy with dual-mite (HDM) preparations, have allergen testing
indicating HDM allergy, and are recruited from multiple clinical research centers
nationwide during the period from October 2025 to October 2028.
4.1 Inclusion Criteria (All of the following must be met)
(1) Age: 5 years ≤age < 18 years.
(2) 1) Allergic rhinitis induced by Dermatophagoides pteronyssinus and/or
Dermatophagoides farinae; OR 2) Serum specific IgE ≥0.70 kU/L (for
Dermatophagoides pteronyssinus and/or Dermatophagoides farinae).
(3) Children meeting criterion (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 bronchial asthma in children (2025
Edition), and asthma symptoms must be confirmed to be well-controlled.
(5) Receiving subcutaneous AIT with dual-mite (HDM) preparations.
4.2 Exclusion Criteria (Meeting any one of the following criteria leads to exclusion)
(1) In the investigator's judgment, the subject and/or parents/legal guardians are
unable to understand and comply with the study requirements, including children and
their parents/legal guardians with cognitive impairments, mental illnesses, or
difficulty adhering to long-term treatment or recognizing adverse reactions.
(2) Children with severe or uncontrolled asthma (FEV1 < 70% predicted value)
or with irreversible airflow obstruction.
(3) Children using beta-blockers or angiotensin-converting enzyme inhibitors
(ACEIs).
(4) Children with severe autoimmune diseases or immunodeficiencies, including
AIDS, inflammatory bowel disease, etc., or those using immunosuppressants.

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(5) Children with severe cardiovascular diseases or malignancies.
(6) Children with incomplete clinical data.
4.3 Withdrawal Criteria
Subjects may voluntarily withdraw from this study at any time for any reason.
Children will also be withdrawn from the study if any of the following occur:
(1) The subject and/or parents/legal guardians fail to follow the project team's
guidance, indicating poor compliance.
(2) The study physician determines that continuing the study would pose
unnecessary harm.
(3) The study is terminated by the Ethics Committee or a regulatory authority.
5. Study Procedures
5.1 Screening Phase
(1) Children and their parents/guardians are informed about the study and agree
to participate, signing the informed consent form.
(2) Children are assigned a study number, and all information is de-identified.
(3) Collection of medical history, including personal basic information, medical
history, primary symptoms, and clinical diagnosis.
(4) Verification that the child meets the inclusion and exclusion criteria.
(5) Assessments
①Subject Characteristics Assessment
a. Demographic data;
b. Allergy history;
c. Comorbidity status;
②Baseline Biological Indicators
Detection using immunoblotting and component microfluidic chip
assays: Intra-assay coefficient of variation (CV) for the same reagent lot and chip lot
<10%; inter-assay CV for the same reagent and chip lot tested at different time points
<15%;
③Exclusion of Confounding Factors
a. Pre-treatment influences: Excluding children currently receiving or
having received anti-IgE immunotherapy within the past six months;

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④Sample Suitability Validation
Serum must avoid hemolysis interference (hemoglobin ≤0.5 g/dL).
Retain serum samples (stored at -80°C).
(6) Eligible subjects are enrolled according to the inclusion/exclusion criteria.
Serum specific IgE is detected by Zhejiang DIA-UP using the immunoblotting
method. A 2ml blood sample is collected in a yellow-top tube, centrifuged at 3000
rpm for 8 minutes, and the upper serum layer is aliquoted into labeled EP tubes.
Serological testing is performed using the allergen component-resolved diagnostics
multiplex assay (microfluidic chip method) from Hyrisky Bio (Xiamen).
5.2 Visit Phase
(1) Enrolled children receive AIT using a dual-mite allergen preparation (NHD,
Dermatophagoides farinae/Dermatophagoides pteronyssinus: 50%/50%). This registry
study does not involve any intervention; it only collects relevant clinical information.
The collection of clinical information does not involve any identifiable private
information of the children (i.e., information is de-identified). All treatment decisions
are made by the clinicians. Clinicians provide the optimal treatment plan for each
child based on the current AIT treatment standards and relevant guidelines of their
respective hospitals. No pre-set grouping is designated for this registry study.
(2) Dynamic Visit Schedule
Visit
Time Window
Testing Content
Clinical Assessment
V1
Baseline
(Month 0)
FeNO/nNO, Eosinophil
percentage and count, sIgE,
Components (sIgE/sIgG4),
SPT, Lung function
VAS, Medication score,
ACT/CACT, Quality of life
assessment, Adverse
reactions
V2
Month 3
FeNO/nNO, Lung function
VAS, Medication score,
ACT/CACT, Quality of life
assessment, Adverse
reactions
V3
Month 6
FeNO/nNO, Lung function
VAS, Medication score,
ACT/CACT, Quality of life
assessment, Adverse
reactions

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V4
Month 12
FeNO/nNO, Eosinophil
percentage and count, sIgE,
Components (sIgE/sIgG4),
SPT, Lung function
VAS, Medication score,
ACT/CACT, Quality of life
assessment, Adverse
reactions
V5
Month 24
FeNO/nNO, Eosinophil
percentage and count, sIgE,
Components (sIgE/sIgG4),
Lung function
VAS, Medication score,
ACT/CACT, Quality of life
assessment, Adverse
reactions
V6
Month 36
FeNO/nNO, Eosinophil
percentage and count, sIgE,
Components (sIgE/sIgG4),
SPT, Lung function
VAS, Medication score,
ACT/CACT, Quality of life
assessment, Adverse
reactions
All children are required to undergo VAS and Allergic Rhinitis Quality of Life assessments.
Children with rhinitis accompanied by asthma additionally require ACT/CACT assessments.
Lung function test results, if completed, are collected according to the clinician's decision.
Abbreviations: FeNO/nNO:Fractional Exhaled Nitric Oxide / Nasal Nitric Oxide; SPT: Skin
Prick Test; Components: Include major components (Der p 1, Der p 2, Der p 23, Der f 1, Der
f 2), intermediate components (Der p 5, Der p 7, Der p 21), and minor components (Der p 10);
VAS: Visual Analog Scale; Medication score: Symptom Medication Score; Quality of life
assessment: Allergic Rhinitis Quality of Life; ACT/CACT: Asthma Control Test / Childhood
Asthma Control Test; sIgE: Specific Immunoglobulin E; sIgG4: Specific Immunoglobulin
G4;
5.3 Data Compilation and Analysis
Data from all participating centers will be compiled and statistically analyzed.
Efficacy will be evaluated by grouping children according to different HDM
component sensitization patterns. The following parameters will be assessed: changes
from baseline in VAS scores and medication scores after 1, 2, and 3 years of AIT in
children with different sensitization patterns; incidence and severity of adverse

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reactions; rates of new sensitization and new-onset asthma; and treatment adherence
rates. Valuable conclusions will be derived.
5.4 Flowchart
6. Evaluation Indicators
6.1 Efficacy Assessment
Assessment
Time (Months)
Primary Indicators
Secondary Indicators
0
VAS,
Medication
ACT/CACT, Quality of life assessment, sIgE,

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score
Components (sIgE/sIgG4), FeNO/nNO,
Eosinophil percentage and count, Adverse
reactions, SPT, Lung function
3, 6
VAS,
Medication
score
ACT/CACT, Quality of life assessment,
FeNO/nNO, Adverse reactions, Lung function
12, 24, 36
VAS,
Medication
score
ACT/CACT, Quality of life assessment, sIgE,
sIgG4, Components (sIgE/sIgG4),
FeNO/nNO, Eosinophil percentage and count,
SPT, Adverse reactions, SPT, Lung function
All children are required to undergo assessment of primary indicators. Children with rhinitis
accompanied by asthma additionally require ACT/CACT assessment. Secondary indicators are
collected based on the clinician's decision for children who complete the relevant examinations.
Lung function test results are collected for children with rhinitis accompanied by asthma.
Abbreviations: VAS: Visual Analog Scale; Medication score: Symptom Medication Score;
ACT/CACT: Asthma Control Test / Childhood Asthma Control Test; Quality of life assessment:
Allergic Rhinitis Quality of Life Assessment; Components: Include major components (Der p 1,
Der p 2, Der p 23, Der f 1, Der f 2), intermediate components (Der p 5, Der p 7, Der p 21), and
minor components (Der p 10); SPT: Skin Prick Test; FeNO/nNO: Fractional Exhaled Nitric Oxide
/ Nasal Nitric Oxide; sIgE: Specific Immunoglobulin E; sIgG4: Specific Immunoglobulin G4;
6.2 Safety Assessment
(1) Local Adverse Reactions: Redness, induration, pruritus, pain at the injection
site; Others: Local lymph node enlargement, gastrointestinal discomfort (nausea,
abdominal pain).
(2) Systemic Adverse Reactions (Graded by Severity)
Grade
Symptoms
Management
Mild
Urticaria, rhinitis, mild asthma
(FEV₁ > 70% predicted)
Oral antihistamines, nebulization,
observation
Moderate
Widespread urticaria, throat
tightness, moderate asthma (FEV₁
60-70% predicted)
Intramuscular epinephrine (0.3-0.5
mg), corticosteroids

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Severe
Anaphylactic shock, asphyxia
(FEV₁ < 60% predicted),
hypotension
Immediate intramuscular
epinephrine (0.5 mg), transfer to
emergency care
7. Risk Prevention and Management
7.1 Data Privacy Risk: The study process involves collecting a large amount of
personal information, posing a risk of information leakage. Strict data protection
measures must be implemented to ensure the security and privacy of this information.
First, data will be de-identified to reduce the risk of personal privacy disclosure.
Second, data access permissions will be restricted to minimize the possibility of
information leakage.
7.2 Result Interpretation Risk: The results of scientific research require careful
interpretation to avoid over-interpretation or misleading conclusions, while also
paying attention to personal privacy protection. All personnel involved in the study
will receive professional training to ensure they can correctly execute the
experimental procedures.
7.3 Adverse Reaction Risk of AIT: The children enrolled in this study will all use
immunotherapy preparations that are widely used in current clinical practice. The
researchers will primarily provide clinical guidance to the children, instructing them
on desensitization treatment and medication use, so the potential clinical risks are
relatively low. Furthermore, if any discomfort, change in condition, or unexpected
situation occurs during the study period, the researchers will promptly make a
judgment and provide appropriate medical advice or treatment to ensure the child's
safety.
Adverse Reaction Prevention Measures:
①Prophylactic Medication: Consider administering antihistamines or
corticosteroids in advance;
②Post-injection Observation: Observe for 30 minutes after injection;

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③Emergency Medication: Children with a history of systemic reactions should
carry an epinephrine auto-injector;
④Symptom Recording: Record symptoms to assist the physician in adjusting
the treatment plan.
Adverse Reaction Management Procedure:
①Immediate Management: Assess the severity of the adverse reaction. For
local itching and redness/swelling, apply ice compresses. For children with mild
systemic reactions, provide observation and antihistamines, etc. For children with
moderate systemic reactions, administer intramuscular epinephrine and corticosteroids.
For children with severe systemic reactions, administer intramuscular epinephrine,
provide oxygen, and place in a supine position. For more severe reactions or cases
that do not improve, transfer the child to emergency care.
②Reporting: Complete an adverse event form and report to the hospital's drug
safety department.
③Treatment Plan Adjustment: For children with mild to moderate reactions,
consider fractionated dosing. For children with severe reactions, suspend AIT and
re-evaluate the indications.
8. Adverse Event Recording and Reporting
During the study period, researchers should closely monitor the occurrence of
adverse events (AEs). In the event of an adverse event (including significant adverse
events), the researcher should analyze the cause, make a judgment, and follow up,
observe, and record the time of onset, symptoms, severity, duration, management
measures, and outcome of the AE, as well as assess its correlation with the study. All
relevant medical documents should be recorded in the source documents, including
laboratory test result reports.
In the event of a serious adverse event (SAE), immediate measures must be taken
to protect the subject. The researcher must promptly complete the "Serious Adverse
Event Report Form" and report it to the Ethics Committee within 24 hours. Subjects
who experience a serious adverse event should be followed up and documented until
the condition resolves or until death.

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9. Data Management
Completion of Case Report Forms (CRFs): Case Report Forms will be
completed by the clinical investigators.
Data Entry and Modification: Data entry and management will be the
responsibility of Yujia Xiao and Shuxian Li. Data entry and management will be
performed using an EDC platform. To ensure data accuracy, two data administrators
will independently perform double data entry and verification.
Database Lock: After confirming that the established database is error-free, the
principal investigator and statistical analysts will lock the database.
10. Statistical Analysis Methods
This study will conduct descriptive and exploratory analyses of the data without
formulating any statistical hypotheses. All statistical analyses will be performed using
SPSS 23.0 software. Count data will be presented as percentages (%). Comparisons
between two groups will be analyzed using the Chi-square test or Fisher's exact test,
as appropriate. Measurement data not following a normal distribution will be
expressed as median (interquartile range). Comparisons between two independent
samples will be conducted using the Wilcoxon rank-sum test. Generalized estimating
equations (GEE) will be employed to evaluate the efficacy of different treatment
regimens. A P-value < 0.05 will be considered statistically significant.
The following outcomes will be calculated: changes in VAS scores and
medication scores from baseline, changes in sIgG4/sIgE ratios, rates of new
sensitization, incidence of adverse reactions, and treatment adherence. Differences
among subgroups stratified by component sensitization profiles will be compared, and
associated influencing factors will be analyzed.

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11. Dissemination of Research Findings
The findings of this research will be disseminated in the form of comprehensive
summary reports and peer-reviewed publications (papers).
12. Ethical Considerations
12.1 Risks and Benefits
This study is a multicenter observational registry study. As an observational
(non-interventional) study, it involves only the collection of relevant clinical
information, with all diagnostic and therapeutic decisions resting solely with the
attending clinicians. Clinicians will provide appropriate treatment based on each
child's specific condition. The potential risk to subjects is confined exclusively to
matters of privacy protection.
Participation in this study may help clarify the specific component sensitization
profile of the child's house dust mite allergy, which could potentially inform decisions
regarding immunotherapy, although this is not guaranteed. Furthermore, the
information generated by this study will contribute valuable insights into diseases
associated with house dust mite allergy, such as allergic rhinitis and asthma,
potentially benefiting future patients suffering from similar conditions.
12.2 Protection of Subject Privacy
Access to subjects' personal medical records will be restricted solely to the
researchers involved in this study. All researchers will sign confidentiality agreements
or investigator statements that explicitly include provisions for maintaining
confidentiality. The Ethics Committee and relevant regulatory authorities have the
right to access clinical trial records. Data processing will employ anonymization
techniques, omitting any information that could identify individual subjects.
Publication of research results will not disclose subjects' personal information.
Subjects' medical records will be securely stored in the archives of the Children's
Hospital, Zhejiang University School of Medicine, under strict security and
confidentiality protocols.

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12.3 Informed Consent and Signing of the Informed Consent Form
Prior to the initiation of the clinical study, the investigator must provide the
subject and their legal guardian with comprehensive information regarding the clinical
study, including its nature, purpose, potential benefits, and risks, ensuring full
comprehension by both parties.
For subjects under 8 years of age who possess sufficient understanding and the
capacity to express their views, the child's willingness to participate must be sought,
in addition to obtaining signed informed consent from their legal guardian.
For subjects aged 8 years and older, signed informed consent is required from
both the legal guardian and the subject themselves.
The clinical study may only commence after the informed consent form has been
duly signed.
Detailed contact information, including address and telephone number, will be
obtained from each patient. Conversely, the physician will provide their own contact
information to the patient, ensuring that the patient can reach the researcher at any
time if needed.

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