Allergic AsthmaNCT05424523
Effectiveness and Safety of Omalizumab in Children With Allergic Asthma.
An observational study of Allergic Asthma, run by Novartis Pharmaceuticals at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- Omalizumab
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2021to 28 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients with allergic asthma treated with omalizumab from July 6, 2018 to September 30, 2020 were identified for medical chart extraction
Who may be able to join
- 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
Who cannot join
- Current participation in a clinical trial of any investigational treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
East Hanover, New Jersey, 07936-1080
About this study
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
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.
Read the 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.
- Conditions
- Allergic Asthma
- Being tested
- Omalizumab
- Keywords
- Omalizumab,, allergic asthma,, children,, real-world study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmalizumabDrug
Patients with confirmed diagnosis of allergic asthma, who were prescribed omalizumab
| Study group | Role | What they receive |
|---|---|---|
| Omalizumab | Patients with confirmed diagnosis of allergic asthma, who were prescribed omalizumab Receives: Drug: Omalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who responded to omalizumab
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
Measured: 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
To evaluate safety of omalizumab among children with allergic asthma in China.
Measured: Throughout the study, approximately 2 years
Proportion of patients with positive investigator's Global Evaluation of Treatment Effectiveness (GETE)
Positive investigator's GETE is defined as restrospectively evaluated GETE are Excellent or Good.
Measured: After 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Change from baseline in moderate-to-severe Asthma exacerbation
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.
Measured: Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Change from baseline in severe Asthma exacerbation
Severe asthma exacerbation is defined as requiring ER admission
/hospitalization/ICU admission/mechanical ventilation with systemic corticosteroids for ≥ 3 days.
Measured: 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
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.
Measured: Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Average change from baseline in daily oral corticosteroids (OCS) dose
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.
Measured: Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Percentage of patients that successfully stopped Oral Corticosteroids
Percentage of patients that successfully stopped Oral Corticosteroids after 4 to 6 months of treatment were reported
Measured: After 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Change from baseline in Lung function using Forced Expiratory Volume in 1 Second (FEV1)
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.
Measured: Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Change from baseline in FEV1% pred
Ratio of patient's actual results compared to predicted normal values, expressed as a percentage.
Measured: Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Change from baseline in FEV1/FVC
The FEV1/FVC ratio indicates how much air you can forcefully exhale.
Measured: Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Change from baseline in Peak Expiratory Flow (PEF)
Peak Expiratory Flow (PEF) is an objective measure of how well the lungs are functioning and can measure airway narrowing.
Measured: Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Change from baseline in Maximal mid-expiratory flow (MMEF)
Maximal mid-expiratory flow (MMEF) is a spirometric parameter reflecting airflow of large and small airways.
Measured: Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Number of patients who received the recommended dosage instructions during the identification period
To describe the treatment pattern of omalizumab among children with allergic asthma in China.
Measured: Throughout the study, approximately 2 years
Median time to discontinuation of the treatment
To describe the treatment pattern of Xolair among children with allergic asthma in China.
Measured: Throughout the study, approximately 2 years
Percentage of patients using Omalizumab for more than 4, 16, 24 and 52 weeks
To describe the treatment pattern of omalizumab among children with allergic asthma in China.
Measured: Week 4, 16, 24 and 52 (Between July 6, 2018 to September 30, 2020)
Number of patients who discontinued omalizumab
To describe the treatment pattern of omalizumab among children with allergic asthma in China.
Measured: Throughout the study, approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start25 Feb 2021
- Primary completion28 Jun 2021
- Study completion28 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic AsthmaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424523
- Sponsor's protocol ID
- CIGE025BCN01
- Status last verified
- Jun 2022
- First submitted
- 15 Jun 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05424523
- Acronym / sponsor ID
- CIGE025BCN01
- Conditions
- Allergic Asthma
- Keywords
- Omalizumab,, allergic asthma,, children,, real-world study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 28 Jun 2021 (actual)
- Study completion
- 28 Jun 2021 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omalizumab | – | Drug: OmalizumabPatients with confirmed diagnosis of allergic asthma, who were prescribed omalizumab |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients with allergic asthma treated with omalizumab from July 6, 2018 to September 30, 2020 were identified for medical chart extraction
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Current participation in a clinical trial of any investigational treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmalizumabPatients with confirmed diagnosis of allergic asthma, who were prescribed omalizumab | Drug | Omalizumab |
Primary outcome
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: 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
16 secondary outcomes
Number of adverse events and serious adverse events
Time frame: Throughout the study, approximately 2 years
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)
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)
Change from baseline in severe Asthma exacerbation
Time frame: 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
Time frame: Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
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)
Percentage of patients that successfully stopped Oral Corticosteroids
Time frame: After 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
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)
Change from baseline in FEV1% pred
Time frame: Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Change from baseline in FEV1/FVC
Time frame: Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
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)
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)
Number of patients who received the recommended dosage instructions during the identification period
Time frame: Throughout the study, approximately 2 years
Median time to discontinuation of the treatment
Time frame: Throughout the study, approximately 2 years
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)
Number of patients who discontinued omalizumab
Time frame: Throughout the study, approximately 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Results for CIGE025BCN01 from the Novartis Clinical Trials Results DatabaseLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Asthma, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who responded to omalizumab (time frame: After 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.