The Impact of Airway Allergic Diseases on Children's and Parents' Quality of Life
NCT ID: NCT06535087
Last Updated: 2024-08-02
Study Results
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Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2024-07-20
2027-05-31
Brief Summary
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Detailed Description
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\[Study Design\] Prospective observational study.
\[Primary Objectives\] Assess the current health-related quality of life (HRQoL) of children with airway allergic diseases (bronchial asthma, allergic rhinitis, or both) using the EQ-5D-Y and disease-specific scales.
Evaluate and compare the dynamic changes in HRQoL over 1 and 2 years in children undergoing routine treatment versus specific immunotherapy. Analyze the impact of treatment type, disease severity, and treatment outcomes.
Determine the impact of allergic diseases on children's HRQoL by comparing them with healthy controls.
\[Secondary Objectives\] Explore the caregiver burden and spillover effects on parents using the PedsQL Family Impact Module, compared with healthy controls.
Compare the QoL of parents based on different treatment plans, disease severities, and treatment outcomes of their children.
Validate the newly developed Chinese versions of EQ-5D-Y and EQ-HWB-S for parents' QoL assessment.
\[Participants\] 200 children (ages 5-16) diagnosed with bronchial asthma, allergic rhinitis, or both, and their 200 parents (caregivers), divided into two groups: 100 children receiving specific immunotherapy and 100 receiving routine treatment.
Control group: 100 healthy children and their parents.
\[Methods\] Children with Allergies: Complete baseline and two follow-up surveys. Use the EQ-5D-Y-3L (3 level of EQ-5D-Y), EQ VAS (Visual Analogue Scale), PAQLQ (Pediatric Asthma Quality of Life Questionnaire) or JRQLQ-No. 1 (Japanese Rhinoconjunctivitis Quality of Life Questionnaire No. 1 ), and Overall Health Assessment (OHA).
Healthy Children: Complete a single baseline survey using EQ-5D-Y-3L, EQ VAS, and OHA.
Parents: Complete EQ-HWB-S, demographic information, EQ-5D-5L, OHA, and PedsQL (Pediatric Quality of Life Inventory) Family Impact Module.
Clinical data collection from medical records including diagnosis, symptoms, laboratory tests (lung function, allergens, eosinophils, IgE, FeNO\[Fractional Exhaled Nitric Oxide\]), treatment plans, side effects, and complications.
\[Inclusion Criteria\] Children with Allergies: Ages 5-16, diagnosed with bronchial asthma, allergic rhinitis, or both, with continuous treatment for ≥4 weeks. Able to understand and complete questionnaires.
Healthy Children: Ages 5-16, without a history of allergic diseases. Able to understand and complete questionnaires.
Parents: Primary caregivers, present during survey, signed informed consent.
\[Study Endpoints\] Completion of the second follow-up survey by the last enrolled child and parent.
\[Primary Outcomes\] Disease severity (Asthma Control Test, ACT). Laboratory tests (lung function, serum allergens, eosinophils, IgE, oral/nasal FeNO)
\[Statistical Methods\] Compare HRQoL before and after treatment in children and parents, and between allergic and healthy groups using t-tests, Wilcoxon rank-sum tests, chi-square tests, or Fisher's exact tests. Use ANOVA, Kruskal-Wallis tests, and chi-square tests for multiple group comparisons. Analyze correlations between HRQoL and influencing factors using multiple regression. Validate HRQoL scales using variance analysis for construct validity and effect size for responsiveness.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Allergic disease group
Receiving: 1) Subcutaneous immunotherapy and 2) Standard Treatment for Asthma and Rhinitis.
Subcutaneous immunotherapy / Standard Treatment for Asthma and Rhinitis
1. Subcutaneous Allergen-Specific Immunotherapy:
* Pre-treatment: Omalizumab subcutaneous injection, with the total IgE level serving as the basis for calculating the dosage for children. The appropriate dosage of omalizumab (each dose ranging from 75 to 600 mg) and administration frequency (once every 4 weeks) are determined based on the baseline IgE (IU/mL, measured before the start of treatment) and body weight (kg).
* Mite Allergen Preparation: (Antergen/Alutard)
2. Standard Treatment:
* Asthma: Inhaled corticosteroids (ICS) combined with long-acting beta-2 agonists, leukotriene receptor antagonists.
* Allergic Rhinitis: Oral antihistamines, nasal antihistamines, nasal corticosteroids, anti-leukotriene drugs, cromolyn sodium, decongestants (oxymetazoline hydrochloride), and nasal saline irrigation.
Healthy control Group
Healthy children aged 5-16 from the Shanghai region, with no history of allergic diseases, and without any intervention.
No interventions assigned to this group
Interventions
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Subcutaneous immunotherapy / Standard Treatment for Asthma and Rhinitis
1. Subcutaneous Allergen-Specific Immunotherapy:
* Pre-treatment: Omalizumab subcutaneous injection, with the total IgE level serving as the basis for calculating the dosage for children. The appropriate dosage of omalizumab (each dose ranging from 75 to 600 mg) and administration frequency (once every 4 weeks) are determined based on the baseline IgE (IU/mL, measured before the start of treatment) and body weight (kg).
* Mite Allergen Preparation: (Antergen/Alutard)
2. Standard Treatment:
* Asthma: Inhaled corticosteroids (ICS) combined with long-acting beta-2 agonists, leukotriene receptor antagonists.
* Allergic Rhinitis: Oral antihistamines, nasal antihistamines, nasal corticosteroids, anti-leukotriene drugs, cromolyn sodium, decongestants (oxymetazoline hydrochloride), and nasal saline irrigation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Aged 5-16 years;
2. Diagnosed with bronchial asthma, allergic rhinitis, or both (persistent, duration ≥4 weeks) by a respiratory or allergy specialist;
3. Guardian has signed the informed consent form;
4. Able to understand and complete the questionnaire;
5. Outpatients or inpatients at the Pediatrics Department of Renji Hospital in Shanghai.
2. Parents:
1. The primary caregiver of the enrolled child;
2. Accompanied the child to the hospital on the day of the visit;
3. Signed the informed consent form;
4. Able to understand and complete the questionnaire.
Exclusion Criteria
1. Poor compliance;
2. Already received specific immunotherapy at another hospital;
3. Unable to independently read and complete the questionnaire;
4. Lost to follow-up or discontinued treatment.
2. Parents:
1. Unwilling to sign the informed consent form;
2. Unable to complete the questionnaire due to physical condition or educational level.
5 Years
16 Years
ALL
Yes
Sponsors
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Wenjing Zhou
OTHER
Responsible Party
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Wenjing Zhou
Principal Investigator
Principal Investigators
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Wenjing Zhou
Role: PRINCIPAL_INVESTIGATOR
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Locations
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Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IIT-2024-0110
Identifier Type: -
Identifier Source: org_study_id
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