Clinical trial NCT05424523: Effectiveness and Safety of Omalizumab in Children With Allergic Asthma.
Official title: A Retrospective Multicenter Study for Assessment of the Effectiveness and Safety of Omalizumab in Children With Allergic Asthma in a Real-world Setting in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Asthma
Keywords: Omalizumab,
allergic asthma,
children,
real-world study
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-06-21
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients who responded to omalizumab
timeFrame: After 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Secondary outcomes:
measure: Number of adverse events and serious adverse events
timeFrame: Throughout the study, approximately 2 years
measure: Proportion of patients with positive investigator's Global Evaluation of Treatment Effectiveness (GETE)
timeFrame: After 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
measure: Change from baseline in moderate-to-severe Asthma exacerbation
timeFrame: Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
measure: Change from baseline in severe Asthma exacerbation
timeFrame: Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
measure: Average change from baseline in daily inhaled corticosteroids (ICS) dose
timeFrame: Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
measure: Average change from baseline in daily oral corticosteroids (OCS) dose
timeFrame: Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
measure: Percentage of patients that successfully stopped Oral Corticosteroids
timeFrame: After 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
measure: Change from baseline in Lung function using Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
measure: Change from baseline in FEV1% pred
timeFrame: Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
measure: Change from baseline in FEV1/FVC
timeFrame: Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
measure: Change from baseline in Peak Expiratory Flow (PEF)
timeFrame: Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
measure: Change from baseline in Maximal mid-expiratory flow (MMEF)
timeFrame: Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
measure: Number of patients who received the recommended dosage instructions during the identification period
timeFrame: Throughout the study, approximately 2 years
measure: Median time to discontinuation of the treatment
timeFrame: Throughout the study, approximately 2 years
measure: Percentage of patients using Omalizumab for more than 4, 16, 24 and 52 weeks
timeFrame: Week 4, 16, 24 and 52 (Between July 6, 2018 to September 30, 2020)
measure: Number of patients who discontinued omalizumab
timeFrame: Throughout the study, approximately 2 years
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Investigative Site
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: