Effectiveness and Safety of Omalizumab in Children With Allergic Asthma.

NCT05424523 | Completed

• 1 other identifier: CIGE025BCN01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Allergic Asthma

Keywords

Omalizumab,; allergic asthma,; children,; real-world study

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who responded to omalizumab

  The responders were defined as patients with: 1. Investigator's Global Evaluation of Treatment Effectiveness (GETE) are Excellent or Good; or 2. C-ACT2 improvement ≥3 points before and after omalizumab treatment

  After 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)

Secondary Outcomes (16)

• Number of adverse events and serious adverse events

  Throughout the study, approximately 2 years

• Proportion of patients with positive investigator's Global Evaluation of Treatment Effectiveness (GETE)

  After 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)

• Change from baseline in moderate-to-severe Asthma exacerbation

  Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)

• Change from baseline in severe Asthma exacerbation

  Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)

• Average change from baseline in daily inhaled corticosteroids (ICS) dose

  Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)

Study Arms (1)

Omalizumab

Patients with confirmed diagnosis of allergic asthma, who were prescribed omalizumab

Drug: Omalizumab

Interventions

Omalizumab DRUG

Patients with confirmed diagnosis of allergic asthma, who were prescribed omalizumab

Omalizumab

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients with allergic asthma treated with omalizumab from July 6, 2018 to September 30, 2020 were identified for medical chart extraction

You may qualify if:

• 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

You may not qualify if:

• Current participation in a clinical trial of any investigational treatment

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

East Hanover, New Jersey, 07936-1080, United States

Location

Related Links

• Results for CIGE025BCN01 from the Novartis Clinical Trials Results Database

MeSH Terms

Interventions

Omalizumab

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 21, 2022
• Study Start: February 25, 2021
• Primary Completion: June 28, 2021
• Study Completion: June 28, 2021
• Last Updated: July 5, 2022

Record last verified: 2022-06

Locations

US (1)