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Prospective randomized controlled clinical trial of the efficacy and safety of omalizumab in the treatment of mild to moderate childhood allergic asthma

Prospective randomized controlled clinical trial of the efficacy and safety of omalizumab in the treatment of mild to moderate childhood allergic asthma

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000041572
Enrollment
Unknown
Registered
2020-12-29
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-03-15

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

Conditions

Allergic asthma

Interventions

experimental group:Omazumab
control group:ICS

Sponsors

Guangzhou Women and Children's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of allergic asthma; 2. Aged 6 to 18 years; 3. Investigator-diagnosed allergic asthma eligible for treatment with omalizumab, with coexisting conditions including allergic rhinitis, atopic dermatitis, nasal polyps, chronic urticaria, and food allergy; 4. The informed consent form have been signed. 5. Able to comply with the requirements of the trial.

Exclusion criteria

Exclusion criteria: 1. According to the judgment of the researchers, patients who can't tolerate the treatment of this program; 2. Patients who are allergic to the drugs in the program; 3. Patients who are unable to receive regular treatment and regular follow-up due to psychological, family and geographical reasons; 4. Patients with severe infection, internal diseases, important organ dysfunction and mental disorders; 5. Patients who have undergone other clinical trials within three months.

Design outcomes

Primary

MeasureTime frame
Global Evaluation of Treatment Effectiveness, GETE;Children Asthma Control Test, C-ACT;

Secondary

MeasureTime frame
Adverse events;Serious adverse events;

Countries

China

Contacts

Public ContactChunhui He

Guangzhou Women and Children's Medical Center

sminthill@hotmail.com+86 13802925949

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026