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

NCT06535087 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2024-08-02

No results posted yet for this study

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.

Conditions

  • Pediatric Asthma
  • Rhinitis, Allergic
  • Quality of Life

Interventions

DRUG

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.

Sponsors & Collaborators

  • Wenjing Zhou

    lead OTHER

Principal Investigators

  • Wenjing Zhou · Renji Hospital, School of Medicine, Shanghai Jiaotong University

Eligibility

Min Age
5 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-20
Primary Completion
2025-06-23
Completion
2027-05-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06535087 on ClinicalTrials.gov