The Impact of Airway Allergic Diseases on Children's and Parents' Quality of Life
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-16
SponsorWenjing Zhou
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
Poor compliance;
Already received specific immunotherapy at another hospital;
Unable to independently read and complete the questionnaire;
Lost to follow-up or discontinued treatment.
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Subcutaneous immunotherapy / Standard Treatment for Asthma and Rhinitis
Drug1. 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.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Allergic disease group1 intervention
Group B: Healthy control Group0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline 1 week before treatment; 2 follow-up every 12 months2
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.
Time frame
Baseline 1 week before treatment; 2 follow-up every 12 months3
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.
Time frame
Baseline 1 week before treatment; 2 follow-up every 12 months4
EQ-VAS for assessing health-related quality of life
A 20-cm visual analogue scale for overall health rating. Higher indicates better HRQoL.
Time frame
Baseline 1 week before treatment; 2 follow-up every 12 monthsSecondary outcomes
1
Pulmonary function for assessing asthma disease severity
Pulmonary function tests include various measurements to assess lung function. Vital capacity measurement determines the maximum amount of air a person can exhale after a maximum inhalation, which helps diagnose conditions like restrictive lung disease. Peak expiratory flow rate (PEFR) measures the highest speed of exhalation, useful in evaluating airway obstruction, commonly in asthma management. Lung volumes include measurements of different capacities, such as total lung capacity, providing insights into lung function. Additionally, diffusion capacity tests assess how well gases like oxygen move from the lungs into the blood, crucial for identifying issues like pulmonary fibrosis or emphysema. PEFR and FEV1 values within 80-100% of the predicted range and a normal FEV1/FVC ratio indicate well-controlled asthma and normal lung function.
Time frame
Baseline 1 week before treatment; 2 follow-up every 12 months2
Peripheral Blood Eosinophils for assessing allergic severity
Peripheral blood eosinophil counts are used to assess the severity of allergic conditions. Normal levels are less than 500 eosinophils per microliter of blood. Elevated counts (eosinophilia) indicate allergic reactions or conditions such as asthma, allergic rhinitis, chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis. Higher eosinophil levels can help in diagnosing allergies, monitoring treatment effectiveness, predicting exacerbations, and guiding the use of biologic therapies.
Time frame
Baseline 1 week before treatment; 2 follow-up every 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Wenjing Zhou
Lead sponsor
RenJi Hospital
Sponsor institution
Source ClinicalTrials.gov