Pediatric AsthmaNCT06535087
The Impact of Airway Allergic Diseases on Children's and Parents' Quality of Life
An observational study of Pediatric Asthma and Rhinitis, Allergic, run by Wenjing Zhou at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Asthma, Rhinitis, Allergic, Quality of Life
- What is being tested?
- Subcutaneous immunotherapy / Standard Treatment for Asthma and Rhinitis
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2024to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200127
Wenjing Zhou, +31685281032, zhoujing2188@163.com
About this study
Official title: The Impact of Airway Allergic Diseases on the Health-related Quality of Life of Children and Their Parents (Caregivers): A Prospective Controlled Study
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.
Read the detailed description
[Research Background] Asthma and allergic rhinitis are common chronic diseases in children, significantly impacting their HRQoL and increasing healthcare burden. Allergen-specific immunotherapy (AIT) is an effective treatment for these conditions, shown to improve symptoms and QoL. This study aims to further understand the impact of AIT on QoL in children and their caregivers, using validated assessment tools and comprehensive clinical data. The findings will contribute to better clinical management and policy-making for pediatric allergic diseases.
[Study Design] Prospective observational study.
[Primary Objectives] Assess the current health-related quality of life (HRQoL) of children with airway allergic diseases (bronchial asthma, allergic rhinitis, or both) using the EQ-5D-Y and disease-specific scales.
Evaluate and compare the dynamic changes in HRQoL over 1 and 2 years in children undergoing routine treatment versus specific immunotherapy. Analyze the impact of treatment type, disease severity, and treatment outcomes.
Determine the impact of allergic diseases on children's HRQoL by comparing them with healthy controls.
[Secondary Objectives] Explore the caregiver burden and spillover effects on parents using the PedsQL Family Impact Module, compared with healthy controls.
Compare the QoL of parents based on different treatment plans, disease severities, and treatment outcomes of their children.
Validate the newly developed Chinese versions of EQ-5D-Y and EQ-HWB-S for parents' QoL assessment.
[Participants] 200 children (ages 5-16) diagnosed with bronchial asthma, allergic rhinitis, or both, and their 200 parents (caregivers), divided into two groups: 100 children receiving specific immunotherapy and 100 receiving routine treatment.
Control group: 100 healthy children and their parents.
[Methods] Children with Allergies: Complete baseline and two follow-up surveys. Use the EQ-5D-Y-3L (3 level of EQ-5D-Y), EQ VAS (Visual Analogue Scale), PAQLQ (Pediatric Asthma Quality of Life Questionnaire) or JRQLQ-No. 1 (Japanese Rhinoconjunctivitis Quality of Life Questionnaire No. 1 ), and Overall Health Assessment (OHA).
Healthy Children: Complete a single baseline survey using EQ-5D-Y-3L, EQ VAS, and OHA.
Parents: Complete EQ-HWB-S, demographic information, EQ-5D-5L, OHA, and PedsQL (Pediatric Quality of Life Inventory) Family Impact Module.
Clinical data collection from medical records including diagnosis, symptoms, laboratory tests (lung function, allergens, eosinophils, IgE, FeNO[Fractional Exhaled Nitric Oxide]), treatment plans, side effects, and complications.
[Inclusion Criteria] Children with Allergies: Ages 5-16, diagnosed with bronchial asthma, allergic rhinitis, or both, with continuous treatment for ≥4 weeks. Able to understand and complete questionnaires.
Healthy Children: Ages 5-16, without a history of allergic diseases. Able to understand and complete questionnaires.
Parents: Primary caregivers, present during survey, signed informed consent.
[Study Endpoints] Completion of the second follow-up survey by the last enrolled child and parent.
[Primary Outcomes] Disease severity (Asthma Control Test, ACT). Laboratory tests (lung function, serum allergens, eosinophils, IgE, oral/nasal FeNO)
[Statistical Methods] Compare HRQoL before and after treatment in children and parents, and between allergic and healthy groups using t-tests, Wilcoxon rank-sum tests, chi-square tests, or Fisher's exact tests. Use ANOVA, Kruskal-Wallis tests, and chi-square tests for multiple group comparisons. Analyze correlations between HRQoL and influencing factors using multiple regression. Validate HRQoL scales using variance analysis for construct validity and effect size for responsiveness.
- Conditions
- Pediatric Asthma, Rhinitis, Allergic, Quality of Life
- Being tested
- Subcutaneous immunotherapy / Standard Treatment for Asthma and Rhinitis
- Keywords
- pediatric allergic disease, health-related quality of life
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous immunotherapy / Standard Treatment for Asthma and RhinitisDrug
Also called Alutard, Antergen, Xolair, Pulmicort
- 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)
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Allergic disease group | Receiving: 1) Subcutaneous immunotherapy and 2) Standard Treatment for Asthma and Rhinitis. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline 1 week before treatment; 2 follow-up every 12 months
Secondary outcomes (2)
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.
Measured: Baseline 1 week before treatment; 2 follow-up every 12 months
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.
Measured: Baseline 1 week before treatment; 2 follow-up every 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start20 Jul 2024
- Primary completion23 Jun 2025 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenjing Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wenjing Zhou, RenJi Hospital
- Investigators
- Wenjing Zhou, Principal investigator, Renji Hospital, School of Medicine, Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535087
- Sponsor's protocol ID
- IIT-2024-0110
- Status last verified
- Aug 2024
- First submitted
- 29 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhou W, Guo X, Ding B, Li Y, Lai Y, Lu Y. Impact of Allergen-Specific Subcutaneous Immunotherapy on 12-Month Health-Related Quality of Life in Children and Their Parental Caregivers. Allergy Asthma Immunol Res. 2026 Jul;18(4):584-598. doi: 10.4168/aair.2026.18.4.584.
PubMed 42547470
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Airway Allergic Diseases on the Health-related Quality of Life of Children and Their Parents (Caregivers): A Prospective Controlled Study
- ClinicalTrials.gov ID
- NCT06535087
- Acronym / sponsor ID
- IIT-2024-0110
- Conditions
- Pediatric Asthma, Rhinitis, Allergic, Quality of Life
- Keywords
- pediatric allergic disease, health-related quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Wenjing ZhouUniversity, hospital or other
- Study start
- 20 Jul 2024 (actual)
- Primary completion
- 23 Jun 2025 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
[Research Background] Asthma and allergic rhinitis are common chronic diseases in children, significantly impacting their HRQoL and increasing healthcare burden. Allergen-specific immunotherapy (AIT) is an effective treatment for these conditions, shown to improve symptoms and QoL. This study aims to further understand the impact of AIT on QoL in children and their caregivers, using validated assessment tools and comprehensive clinical data. The findings will contribute to better clinical management and policy-making for pediatric allergic diseases.
[Study Design] Prospective observational study.
[Primary Objectives] Assess the current health-related quality of life (HRQoL) of children with airway allergic diseases (bronchial asthma, allergic rhinitis, or both) using the EQ-5D-Y and disease-specific scales.
Evaluate and compare the dynamic changes in HRQoL over 1 and 2 years in children undergoing routine treatment versus specific immunotherapy. Analyze the impact of treatment type, disease severity, and treatment outcomes.
Determine the impact of allergic diseases on children's HRQoL by comparing them with healthy controls.
[Secondary Objectives] Explore the caregiver burden and spillover effects on parents using the PedsQL Family Impact Module, compared with healthy controls.
Compare the QoL of parents based on different treatment plans, disease severities, and treatment outcomes of their children.
Validate the newly developed Chinese versions of EQ-5D-Y and EQ-HWB-S for parents' QoL assessment.
[Participants] 200 children (ages 5-16) diagnosed with bronchial asthma, allergic rhinitis, or both, and their 200 parents (caregivers), divided into two groups: 100 children receiving specific immunotherapy and 100 receiving routine treatment.
Control group: 100 healthy children and their parents.
[Methods] Children with Allergies: Complete baseline and two follow-up surveys. Use the EQ-5D-Y-3L (3 level of EQ-5D-Y), EQ VAS (Visual Analogue Scale), PAQLQ (Pediatric Asthma Quality of Life Questionnaire) or JRQLQ-No. 1 (Japanese Rhinoconjunctivitis Quality of Life Questionnaire No. 1 ), and Overall Health Assessment (OHA).
Healthy Children: Complete a single baseline survey using EQ-5D-Y-3L, EQ VAS, and OHA.
Parents: Complete EQ-HWB-S, demographic information, EQ-5D-5L, OHA, and PedsQL (Pediatric Quality of Life Inventory) Family Impact Module.
Clinical data collection from medical records including diagnosis, symptoms, laboratory tests (lung function, allergens, eosinophils, IgE, FeNO[Fractional Exhaled Nitric Oxide]), treatment plans, side effects, and complications.
[Inclusion Criteria] Children with Allergies: Ages 5-16, diagnosed with bronchial asthma, allergic rhinitis, or both, with continuous treatment for ≥4 weeks. Able to understand and complete questionnaires.
Healthy Children: Ages 5-16, without a history of allergic diseases. Able to understand and complete questionnaires.
Parents: Primary caregivers, present during survey, signed informed consent.
[Study Endpoints] Completion of the second follow-up survey by the last enrolled child and parent.
[Primary Outcomes] Disease severity (Asthma Control Test, ACT). Laboratory tests (lung function, serum allergens, eosinophils, IgE, oral/nasal FeNO)
[Statistical Methods] Compare HRQoL before and after treatment in children and parents, and between allergic and healthy groups using t-tests, Wilcoxon rank-sum tests, chi-square tests, or Fisher's exact tests. Use ANOVA, Kruskal-Wallis tests, and chi-square tests for multiple group comparisons. Analyze correlations between HRQoL and influencing factors using multiple regression. Validate HRQoL scales using variance analysis for construct validity and effect size for responsiveness.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allergic disease group | – | Drug: Subcutaneous immunotherapy / Standard Treatment for Asthma and RhinitisReceiving: 1) Subcutaneous immunotherapy and 2) 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. |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (11 listed)
- Children:
- Parents:
Key exclusion criteria (8 listed)
- Children:
- Parents:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subcutaneous immunotherapy / Standard Treatment for Asthma and RhinitisAlso: Alutard, Antergen, Xolair, Pulmicort1. 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. | Drug | Allergic disease group |
Primary outcome
Asthma control level for asthmatic children
Time frame: Baseline 1 week before treatment; 2 follow-up every 12 months
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.
Severity assessment of allergic rhinitis
Time frame: Baseline 1 week before treatment; 2 follow-up every 12 months
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.
EQ-5D-Y-3L for assessing health-related quality of life
Time frame: Baseline 1 week before treatment; 2 follow-up every 12 months
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.
EQ-VAS for assessing health-related quality of life
Time frame: Baseline 1 week before treatment; 2 follow-up every 12 months
A 20-cm visual analogue scale for overall health rating. Higher indicates better HRQoL.
PAQLQ for assessing health-related quality of life in children with asthma
Time frame: Baseline 1 week before treatment; 2 follow-up every 12 months
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.
JRQLQ-No. 1 for assessing health-related quality of life in children with allergic rhinitis
Time frame: Baseline 1 week before treatment; 2 follow-up every 12 months
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.
2 secondary outcomes
Pulmonary function for assessing asthma disease severity
Time frame: Baseline 1 week before treatment; 2 follow-up every 12 months
Peripheral Blood Eosinophils for assessing allergic severity
Time frame: Baseline 1 week before treatment; 2 follow-up every 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Derived from this study: PubMed 42547470Zhou W, Guo X, Ding B, Li Y, Lai Y, Lu Y. Impact of Allergen-Specific Subcutaneous Immunotherapy on 12-Month Health-Related Quality of Life in Children and Their Parental Caregivers. Allergy Asthma Immunol Res. 2026 Jul;18(4):584-598. doi: 10.4168/aair.2026.18.4.584.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wenjing Zhou principal investigator
Renji Hospital, School of Medicine, Shanghai Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Asthma and Rhinitis, Allergic, run by Wenjing Zhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenjing Zhou (+31685281032, zhoujing2188@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma control level for asthmatic children (time frame: Baseline 1 week before treatment; 2 follow-up every 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06535087, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.