Assessing the impact of airway allergic diseases on children's and parents' quality of life

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the health-related quality of life (HRQoL) of 200 children aged 5-16 with bronchial asthma, allergic rhinitis, or both, alongside their parents. It compares 100 children receiving specific immunotherapy to 100 receiving routine treatment, using validated questionnaires to assess changes in HRQoL over one and two years. A control group of 100 healthy children and their parents will also be included to analyze the impact of allergic diseases on quality of life and caregiver burden. The study aims to provide insights that could enhance clinical management and inform policy for pediatric allergic conditions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Children:

   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. Children:

   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.

Where it's running

• Renji Hospital, School of Medicine, Shanghai Jiaotong University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Wenjing Zhou — Renji Hospital, School of Medicine, Shanghai Jiaotong University
• Study coordinator: Wenjing Zhou
• Email: zhoujing2188@163.com
• Phone: +31685281032

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.