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

NCT06535087 | Recruiting DMC FDA Drug

• 1 other identifier: IIT-2024-0110
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pediatric allergic disease, health-related quality of life

Outcome Measures

Primary Outcomes (6)

• Asthma control level for asthmatic children

  The child or their parent recalls the frequency of asthma symptoms over the past four weeks, including daily activities, coughing, wheezing, use of asthma medications, and nighttime sleep. The attending physician collects this information during the consultation and assesses the severity of the condition. For individuals aged 12 and above, the Asthma Control Test (ACT) scores are interpreted as follows: a score of 25 or above indicates fully controlled asthma, 20-24 indicates well-controlled asthma, and 19 or below indicates uncontrolled asthma. For children aged 4 to 11, the Childhood Asthma Control Test (C-ACT) scores are interpreted similarly: a score of 24 or above indicates fully controlled asthma, 20-23 indicates well-controlled asthma, and 19 or below indicates uncontrolled asthma.

  Baseline 1 week before treatment; 2 follow-up every 12 months

• Severity assessment of allergic rhinitis

  The attending physician collects information on the patient's symptoms over the past four weeks, including sleep disturbances, limitations in daily activities such as leisure and exercise, limitations in learning, and symptoms (such as nasal itching, nasal congestion, runny nose, and sneezing) that did not cause significant discomfort. The physician then assesses the severity of the condition based on this information. Mild: None of the following are present: sleep disturbances, limitations on daily activities such as leisure/sports, learning limitations, and symptoms (itchy nose, nasal congestion, runny nose, sneezing) that do not cause distress. Moderate to Severe: One or more of the above symptoms are present.

  Baseline 1 week before treatment; 2 follow-up every 12 months

• EQ-5D-Y-3L for assessing health-related quality of life

  The EQ-5D-Y-3L assesses HRQoL with five dimensions (mobility; looking after myself; doing usual activities; having pain or discomfort; and feeling worried, sad, or unhappy) and three severity levels. Each health state in the EQ-5D-Y-3L can be summarized using level descriptors, generating 243 (35) unique states. The best state, 11111, indicates 'no problems' in any dimension, while the worst state, 33333, indicates 'a lot of problems' in all dimensions. An index score of 1.0 represent the value of full health, and a score of 0.0 the value of death. Negative values represent health states with values below the value of death.

  Baseline 1 week before treatment; 2 follow-up every 12 months

• EQ-VAS for assessing health-related quality of life

  A 20-cm visual analogue scale for overall health rating. Higher indicates better HRQoL.

  Baseline 1 week before treatment; 2 follow-up every 12 months

• PAQLQ for assessing health-related quality of life in children with asthma

  The questionnaire includes symptoms (10 questions), activities (5 questions), and emotional functioning (8 questions), using a 7-point scale where 1 is the worst and 7 is the best. The total score is the sum of the scores for each dimension, with higher scores indicating better quality of life and lower scores indicating worse quality of life. A score greater than 66% of the total possible score indicates a high quality of life, 33%-66% indicates a moderate quality of life, and less than 33% indicates a low quality of life.

  Baseline 1 week before treatment; 2 follow-up every 12 months

• JRQLQ-No. 1 for assessing health-related quality of life in children with allergic rhinitis

  The JRQLQ-No.1 questionnaire consists of 3 sections with a total of 24 items. Scoring: Calculate the average score for the first and second sections, then add the scores of all three sections and calculate the overall average score. Each item is scored on a scale, where higher scores indicate a better quality of life and lower scores indicate a worse quality of life. The minimum possible score is 1, indicating the worst outcome, and the maximum possible score is 7, indicating the best outcome.

  Baseline 1 week before treatment; 2 follow-up every 12 months

Secondary Outcomes (2)

• Pulmonary function for assessing asthma disease severity

  Baseline 1 week before treatment; 2 follow-up every 12 months

• Peripheral Blood Eosinophils for assessing allergic severity

  Baseline 1 week before treatment; 2 follow-up every 12 months

Study Arms (2)

Allergic disease group

Receiving: 1) Subcutaneous immunotherapy and 2) Standard Treatment for Asthma and Rhinitis.

Drug: Subcutaneous immunotherapy / Standard Treatment for Asthma and Rhinitis

Healthy control Group

Healthy children aged 5-16 from the Shanghai region, with no history of allergic diseases, and without any intervention.

Interventions

Subcutaneous immunotherapy / Standard Treatment for Asthma and Rhinitis DRUG

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.

Also known as: Alutard, Antergen, Xolair, Pulmicort, Bricanyl, Singulair, Zyrtec

Allergic disease group

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study involves 200 children aged 5-16 years diagnosed with bronchial asthma, allergic rhinitis, or both, along with their 200 parents (direct caregivers). Of these children, 100 will receive allergen-specific immunotherapy, while the other 100 will undergo conventional treatment. Additionally, the control group consists of 100 pairs of healthy children and their parents.

You may qualify if:

• Children:
• Aged 5-16 years;
• Diagnosed with bronchial asthma, allergic rhinitis, or both (persistent, duration ≥4 weeks) by a respiratory or allergy specialist;
• Guardian has signed the informed consent form;
• Able to understand and complete the questionnaire;
• Outpatients or inpatients at the Pediatrics Department of Renji Hospital in Shanghai.
• Parents:
• The primary caregiver of the enrolled child;
• Accompanied the child to the hospital on the day of the visit;
• Signed the informed consent form;
• Able to understand and complete the questionnaire.

You may not qualify if:

• Children:
• Poor compliance;
• Already received specific immunotherapy at another hospital;
• Unable to independently read and complete the questionnaire;
• Lost to follow-up or discontinued treatment.
• Parents:
• Unwilling to sign the informed consent form;
• Unable to complete the questionnaire due to physical condition or educational level.

Sponsors & Collaborators

• Wenjing Zhou: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

complete blood count

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Alutard SQ allergen; Omalizumab; Budesonide; Terbutaline; montelukast; Cetirizine

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Wenjing Zhou

  Renji Hospital, School of Medicine, Shanghai Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenjing Zhou

CONTACT

+31685281032; zhoujing2188@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 2, 2024
• Study Start: July 20, 2024
• Primary Completion: June 23, 2025
• Study Completion (Estimated): May 31, 2027
• Last Updated: August 2, 2024

Record last verified: 2024-08

Locations

CN (1)