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Study on the Role of Omalizumab in Children with Severe Allergic Reactions

Study on the Role of Omalizumab in Children with Severe Allergic Reactions

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600129505
Enrollment
Unknown
Registered
2026-08-05
Start date
2023-05-10
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial asthma, severe allergic reaction

Interventions

The group of children with asthma and severe anaphylaxis:None

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 16 Years

Inclusion criteria

Inclusion criteria: 1. From March 2023 to March 2026, children aged 5–16 years diagnosed with severe anaphylaxis and treated with omalizumab at the First Affiliated Hospital of Xi'an Jiaotong University were enrolled as study subjects. 2. According to the 2021 Chinese recommendations for the diagnosis and treatment of pediatric anaphylaxis, the diagnostic criteria for anaphylaxis are as follows: (1) acute onset of skin and/or mucosal symptoms within minutes to hours, accompanied by at least one of the following: respiratory symptoms, hypotension or end-organ dysfunction, or severe gastrointestinal symptoms; (2) acute onset of hypotension, bronchospasm, or laryngeal symptoms within minutes to hours after exposure to a known or suspected allergen, which may occur without typical skin/mucosal symptoms.

Exclusion criteria

Exclusion criteria: 1. Patients who are allergic to the components or excipients of omalizumab; 2. Children who are experiencing an acute exacerbation of severe allergic reaction or who have concurrent acute bronchial asthma; 3. Patients who are receiving other targeted drug treatments; 4. Patients using beta-blockers for treatment; 5. Patients with missing clinical data or who have withdrawn prematurely.

Design outcomes

Primary

MeasureTime frame
Frequency of severe allergic reactions;

Secondary

MeasureTime frame
Pulmonary function;Fractional exhaled nitric oxide (FeNO);Pediatric Asthma Quality of Life Questionnaire (PAQLQ);Childhood Asthma Control Test (C-ACT);Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ);Nasal symptom score and visual analog scale (VAS);Dermatology Life Quality Index (DLQI);Urticaria Activity Score (UAS);Eczema Area and Severity Index (EASI);

Countries

China

Contacts

Public ContactShi Rui Ming

The First Affiliated Hospital of Xi'an Jiaotong University

srm1975@sohu.com+86 29 91232657

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026