[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557205":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":31,"centralContacts":36,"locations":41,"responsibleParty":57,"collaborators":10,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":10,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":10,"studyType":74,"phases":10,"briefSummary":75,"conditions":76,"keywords":80,"overallStatus":43,"whyStopped":10,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"RenJi Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Allergic disease group",null,"Receiving: 1) Subcutaneous immunotherapy and 2) Standard Treatment for Asthma and Rhinitis.",[13],"Drug: Subcutaneous immunotherapy \u002F Standard Treatment for Asthma and Rhinitis",{"label":15,"type":10,"description":16,"interventionNames":10},"Healthy control Group","Healthy children aged 5-16 from the Shanghai region, with no history of allergic diseases, and without any intervention.",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Subcutaneous immunotherapy \u002F Standard Treatment for Asthma and Rhinitis","1. Subcutaneous Allergen-Specific Immunotherapy:\n\n   * 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\u002FmL, measured before the start of treatment) and body weight (kg).\n   * Mite Allergen Preparation: (Antergen\u002FAlutard)\n2. Standard Treatment:\n\n   * Asthma: Inhaled corticosteroids (ICS) combined with long-acting beta-2 agonists, leukotriene receptor antagonists.\n   * Allergic Rhinitis: Oral antihistamines, nasal antihistamines, nasal corticosteroids, anti-leukotriene drugs, cromolyn sodium, decongestants (oxymetazoline hydrochloride), and nasal saline irrigation.",[9],[24,25,26,27,28,29,30],"Alutard","Antergen","Xolair","Pulmicort","Bricanyl","Singulair","Zyrtec",[32],{"name":33,"affiliation":34,"role":35},"Wenjing Zhou","Renji Hospital, School of Medicine, Shanghai Jiaotong University","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":10,"email":40},"CONTACT","+31685281032","zhoujing2188@163.com",[42],{"facility":34,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Shanghai","Shanghai Municipality","200127","China","CN",{"type":50,"coordinates":51},"Point",[52,53],121.45806,31.22222,{"lat":53,"lon":52},[56],{"name":33,"role":38,"phone":39,"phoneExt":10,"email":40},{"type":58,"investigatorFullName":33,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Principal Investigator","100557205","the-impact-of-airway-allergic-diseases-on-childrens-and-parents-quality-of-life-100557205",false,"NCT06535087","The Impact of Airway Allergic Diseases on Children's and Parents' Quality of Life","The Impact of Airway Allergic Diseases on the Health-related Quality of Life of Children and Their Parents (Caregivers): A Prospective Controlled Study","Inclusion Criteria:\n\n1. Children:\n\n   1. Aged 5-16 years;\n   2. Diagnosed with bronchial asthma, allergic rhinitis, or both (persistent, duration ≥4 weeks) by a respiratory or allergy specialist;\n   3. Guardian has signed the informed consent form;\n   4. Able to understand and complete the questionnaire;\n   5. Outpatients or inpatients at the Pediatrics Department of Renji Hospital in Shanghai.\n2. Parents:\n\n   1. The primary caregiver of the enrolled child;\n   2. Accompanied the child to the hospital on the day of the visit;\n   3. Signed the informed consent form;\n   4. Able to understand and complete the questionnaire.\n\nExclusion Criteria:\n\n1. Children:\n\n   1. Poor compliance;\n   2. Already received specific immunotherapy at another hospital;\n   3. Unable to independently read and complete the questionnaire;\n   4. Lost to follow-up or discontinued treatment.\n2. Parents:\n\n   1. Unwilling to sign the informed consent form;\n   2. Unable to complete the questionnaire due to physical condition or educational level.",true,"ALL","5 Years","16 Years",{"count":72,"type":73},600,"ESTIMATED","OBSERVATIONAL","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.",[77,78,79],"Pediatric Asthma","Rhinitis, Allergic","Quality of Life",[81],"pediatric allergic disease, health-related quality of life","2024-08-01",{"date":84,"type":85},"2024-08-02","ACTUAL",{"date":87,"type":85},"2024-07-20",{"date":89,"type":73},"2027-05-31",{"name":33,"class":6},1]