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Effectiveness and Safety of Omalizumab in Children With Allergic Asthma.

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Novartis

Status

Completed

Conditions

Allergic Asthma

Treatments

Drug: Omalizumab

Study type

Observational

Funder types

Industry

Identifiers

NCT05424523
CIGE025BCN01

Details and patient eligibility

About

The study was the non-interventional, retrospective study aimed to assess the effectiveness and safety of omalizumab in children with allergic asthma in China, and described patient profiles and treatment patterns of omalizumab in real-world practice.

Full description

This non-interventional, retrospective study aimed to assess the effectiveness and safety of omalizumab in children with allergic asthma in China, and described patient profiles and treatment patterns of omalizumab in real-world practice. This study was designed to use secondary data from medical charts of 25 hospitals. Medical records were reviewed to collect information such as demographics, clinical characteristics, treatment patterns, effectiveness, and AEs for retrospective analysis. Patients with allergic asthma aged 6 -<12 years treated with omalizumab from July 6, 2018 to September 30, 2020 were identified for medical chart extraction.

Enrollment

200 patients

Sex

All

Ages

6 to 11 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Aged between 6 -<12 years
  • Diagnosed with allergic asthma and could be treated using omalizumab. Comorbidities included allergic rhinitis, atopic dermatitis, nasal polyp, chronic urticaria, and food allergy
  • Received omalizumab during the identification period
  • Had at least one documented follow-up data after omalizumab treatment
  • Provided informed consent if required by ethics committee (EC) of hospital

Exclusion criteria

  • Current participation in a clinical trial of any investigational treatment

Trial design

200 participants in 1 patient group

Omalizumab
Description:
Patients with confirmed diagnosis of allergic asthma, who were prescribed omalizumab
Treatment:
Drug: Omalizumab

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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