Effectiveness and Safety of Omalizumab in Children With Allergic Asthma.

NCT ID: NCT05424523

Last Updated: 2022-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-25

Study Completion Date

2021-06-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Allergic Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Omalizumab

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

Omalizumab

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Omalizumab

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis Investigative Site

East Hanover, New Jersey, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17947

Results for CIGE025BCN01 from the Novartis Clinical Trials Results Database

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CIGE025BCN01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

ICATA Asthma Mechanistic Study
NCT00377390 COMPLETED
Omalizumab Before Onset of Exacerbations
NCT05332067 RECRUITING PHASE2