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NCT Number: NCT05424523

Effectiveness and Safety of Omalizumab in Children With Allergic Asthma.

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.

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Key information

Conditions

Allergic Asthma

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omalizumab

Drug

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

Primary outcomes

  1. Proportion of patients who responded to omalizumab

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

    The responders were defined as patients with:

    • Investigator's Global Evaluation of Treatment Effectiveness (GETE) are Excellent or Good; or
    • C-ACT2 improvement ≥3 points before and after omalizumab treatment

Secondary outcomes

  1. Number of adverse events and serious adverse events

    Time frame: Throughout the study, approximately 2 years

    To evaluate safety of omalizumab among children with allergic asthma in China.

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

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

    Positive investigator's GETE is defined as restrospectively evaluated GETE are Excellent or Good.

  3. Change from baseline in moderate-to-severe Asthma exacerbation

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

    Moderate-to-severe asthma exacerbation is defined as worsening of asthma symptoms requiring doubling of baseline ICS dose and/or treatment with rescue systemic corticosteroids for ≥ 3 days.

  4. Change from baseline in severe Asthma exacerbation

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

    Severe asthma exacerbation is defined as requiring ER admission

    /hospitalization/ICU admission/mechanical ventilation with systemic corticosteroids for ≥ 3 days.

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

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

    The dosage of inhaled corticosteroids (ICS) was reported to evaluate the effectiveness of omalizumab among children aged 6 -<12 years with allergic asthma in China.

  6. Average change from baseline in daily oral corticosteroids (OCS) dose

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

    The dosage of oral corticosteroids (OCS) was reported to evaluate the effectiveness of omalizumab among children aged 6 -<12 years with allergic asthma in China.

  7. Percentage of patients that successfully stopped Oral Corticosteroids

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

    Percentage of patients that successfully stopped Oral Corticosteroids after 4 to 6 months of treatment were reported

  8. Change from baseline in Lung function using Forced Expiratory Volume in 1 Second (FEV1)

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

    Lung function was assessed using Forced Expiratory Volume in 1 Second (FEV1) to evaluate the effectiveness of omalizumab among children aged 6 -<12 years with allergic asthma in China. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.

  9. Change from baseline in FEV1% pred

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

    Ratio of patient's actual results compared to predicted normal values, expressed as a percentage.

  10. Change from baseline in FEV1/FVC

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

    The FEV1/FVC ratio indicates how much air you can forcefully exhale.

  11. Change from baseline in Peak Expiratory Flow (PEF)

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

    Peak Expiratory Flow (PEF) is an objective measure of how well the lungs are functioning and can measure airway narrowing.

  12. Change from baseline in Maximal mid-expiratory flow (MMEF)

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

    Maximal mid-expiratory flow (MMEF) is a spirometric parameter reflecting airflow of large and small airways.

  13. Number of patients who received the recommended dosage instructions during the identification period

    Time frame: Throughout the study, approximately 2 years

    To describe the treatment pattern of omalizumab among children with allergic asthma in China.

  14. Median time to discontinuation of the treatment

    Time frame: Throughout the study, approximately 2 years

    To describe the treatment pattern of Xolair among children with allergic asthma in China.

  15. Percentage of patients using Omalizumab for more than 4, 16, 24 and 52 weeks

    Time frame: Week 4, 16, 24 and 52 (Between July 6, 2018 to September 30, 2020)

    To describe the treatment pattern of omalizumab among children with allergic asthma in China.

  16. Number of patients who discontinued omalizumab

    Time frame: Throughout the study, approximately 2 years

    To describe the treatment pattern of omalizumab among children with allergic asthma in China.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 21, 2022
Registry last updated
Jul 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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