RecruitingNCT06535087

The Impact of Airway Allergic Diseases on Children's and Parents' Quality of Life

The Impact of Airway Allergic Diseases on the Health-related Quality of Life of Children and Their Parents (Caregivers): A Prospective Controlled Study

Sponsor

Wenjing Zhou

Enrollment

600 participants

Start Date

Jul 20, 2024

Study Type

OBSERVATIONAL

Conditions

Quality of Life Pediatric Asthma Rhinitis, Allergic

Summary

This prospective observational study aims to assess the health-related quality of life (HRQoL) of 200 children (ages 5-16) with bronchial asthma, allergic rhinitis, or both, and their 200 parents, comparing 100 children receiving specific immunotherapy with 100 receiving routine treatment. Using EQ-5D-Y(EuroQol five dimensions questionnaire, youth version), disease-specific scales, and newly developed Chinese versions of EQ-5D-Y and EQ-HWB-S (EuroQol health and well-being questionnaire, short version), the study evaluates HRQoL changes over 1 and 2 years and explores the impact on caregiver burden and spillover effects. A control group of 100 healthy children and their parents will be included. Data collection involves baseline and follow-up surveys, clinical data from medical records, and statistical analyses to compare treatment effects and validate measurement tools.

Eligibility

Min Age: 5 YearsMax Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how allergic airway diseases — like asthma and allergic runny nose — affect the daily lives and wellbeing of children and their parents. Researchers at a hospital in Shanghai are using questionnaires to measure the quality-of-life impact on both kids and caregivers. **You may be eligible if...** - Your child is between 5 and 16 years old - Your child has been diagnosed with asthma, allergic rhinitis (hay fever), or both, for at least 4 weeks - You are the primary caregiver who accompanies the child to visits - You can read and complete questionnaires **You may NOT be eligible if...** - Your child has already received allergy immunotherapy at another hospital - Your child cannot independently complete questionnaires - You are unable to fill out forms due to health or literacy limitations Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSubcutaneous 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.