AsthmaNCT02921178
Effects of Omalizumab Compared to Non-Omalizumab Treatment in Asthma Patients
An observational study of Asthma, run by Ajou University School of Medicine.
Trial summary
The purpose of this study is effects of Omalizumab compared to non-Omalizumab treatment in the propensity-matched group on asthma exacerbation in asthma patients in Korea: a retrospective cohort in real world. Omalizumab was approved 2007 in Korea and has been used in this center. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- Omalizumab
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Sep 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult asthmatic patients(Duration of accumulated data electronic medical records)
Who may be able to join
- Codes for asthma (ICD-10: J45) dependent on availability
- Who have been diagnosed as having allergic asthma with asthma exacerbations (J45 asthma, J45.0 predominantly allergic asthma and J45.8 mixed asthma)
- Those who initially diagnosed as J45.9 asthma, unspecified, we will refer the evidence of allergic components such as IgE level and skin prick test result.
- Aged 18-80 years at index date
- Active asthma, defined as ≥ 1 prescriptions for LABA/ICS during baseline periods
- un-controlled asthma during the baseline period Any one of three criteria A. Asthma exacerbation B. Asthma-related ER visit/Hospitalization C. Physician defined un-controlled asthma
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- Worsening symptom status
- Worsens on tapering of high dose ICS or systemic CS
- Air flow limitation (after appropriate bronchodilator withhold FEV1%<80% predicted)
Who cannot join
- taken biologics during baseline and outcome period
About this study
Official title: Effects of Omalizumab Compared to Non-Omalizumab Treatment in the Propensity- Matched Group on Asthma Exacerbation in Asthma Patients in Korea: a Retrospective Cohort in a Real World
The purpose of this study is effects of Omalizumab compared to non-Omalizumab treatment in the propensity-matched group on asthma exacerbation in asthma patients in Korea: a retrospective cohort in real world.
Omalizumab was approved 2007 in Korea and has been used in this center. We would like to collect and analyze the data and exacerbation outcomes of these patients on Omalizumab; no Korean real world data available.
Read the detailed description
- Primary and secondary outcomes and analysis methods (1) Primary endpoint Comparison of asthma exacerbation rates of omalizumab-treated vs non-Omalizumab treated group at outcome period (6 months). (asthma exacerbation: at least 1 systemic steroid treatment and/or bursts of systemic oral steroid use by prednisone-equivalent dose ≥45mg/3days, in a 6 month for relieving asthma exacerbations.) Fisher's exact test is examined for asthma exacerbation between omalizumab-treated vs non-Omalizumab treated group. (2) Secondary endpoint
- Comparison of the clinical parameters Asthma exacerbation rate, ICS sparing effect, OCS requirement, lung function (FEV1%), Healthcare resource use (asthma-related ER visit/hospitalization)
- Within Omalizumab-treated group between baseline and outcome period
- Between Omalizumab-treated and not-treated groups at outcome period For comparison of within group, paired T-test and McNemar test are applied for continuous and categorical parameters, respectively. And, T-test and Fisher's exact test are examined for continuous and categorical parameters between Omalizumab-treated and not-treated groups. Incidentally, non-parametric tests will be examined as needed.
- Finding predictor of favorable responders to Omalizumab at 6 months. (Favorable responder: 50% reduction of asthma exacerbation or of steroid requirement during 6 months with/without ICS/LABA) Candidate factors: Omalizumab treatment period/monthly dose, age, gender, asthma treatment duration, total IgE, sputum cell profile, peripheral eosinophilia serum periostin level, anti-asthmatic drug requirements etc.
Binary logistic regression is used for finding predictor of favorable responders. If a serious imbalance of dependent parameter occurs from a low frequency of favorable responder, the descriptive analysis will be applied with T-test and Fisher's exact test.
- Conditions
- Asthma
- Being tested
- Omalizumab
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmalizumabOther
Also called Xolair
comparision of using Omalizumab and non-Omalizumab treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
asthma exacerbation rate
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hae-Sim Park, Ajou University School of Medicine
- Investigators
- Hae-sim Park, Ph.D., Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921178
- Sponsor's protocol ID
- AJIRB-MED-MDB-16-276
- Status last verified
- Sep 2016
- First submitted
- 22 Sep 2016
- Last updated
- 3 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Omalizumab Compared to Non-Omalizumab Treatment in the Propensity- Matched Group on Asthma Exacerbation in Asthma Patients in Korea: a Retrospective Cohort in a Real World
- ClinicalTrials.gov ID
- NCT02921178
- Acronym / sponsor ID
- AJIRB-MED-MDB-16-276
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 3 Oct 2016 (estimated)
- 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 purpose of this study is effects of Omalizumab compared to non-Omalizumab treatment in the propensity-matched group on asthma exacerbation in asthma patients in Korea: a retrospective cohort in real world.
Omalizumab was approved 2007 in Korea and has been used in this center. We would like to collect and analyze the data and exacerbation outcomes of these patients on Omalizumab; no Korean real world data available.
Detailed description
- Primary and secondary outcomes and analysis methods (1) Primary endpoint Comparison of asthma exacerbation rates of omalizumab-treated vs non-Omalizumab treated group at outcome period (6 months). (asthma exacerbation: at least 1 systemic steroid treatment and/or bursts of systemic oral steroid use by prednisone-equivalent dose ≥45mg/3days, in a 6 month for relieving asthma exacerbations.) Fisher's exact test is examined for asthma exacerbation between omalizumab-treated vs non-Omalizumab treated group. (2) Secondary endpoint
- Comparison of the clinical parameters Asthma exacerbation rate, ICS sparing effect, OCS requirement, lung function (FEV1%), Healthcare resource use (asthma-related ER visit/hospitalization)
- Within Omalizumab-treated group between baseline and outcome period
- Between Omalizumab-treated and not-treated groups at outcome period For comparison of within group, paired T-test and McNemar test are applied for continuous and categorical parameters, respectively. And, T-test and Fisher's exact test are examined for continuous and categorical parameters between Omalizumab-treated and not-treated groups. Incidentally, non-parametric tests will be examined as needed.
- Finding predictor of favorable responders to Omalizumab at 6 months. (Favorable responder: 50% reduction of asthma exacerbation or of steroid requirement during 6 months with/without ICS/LABA) Candidate factors: Omalizumab treatment period/monthly dose, age, gender, asthma treatment duration, total IgE, sputum cell profile, peripheral eosinophilia serum periostin level, anti-asthmatic drug requirements etc.
Binary logistic regression is used for finding predictor of favorable responders. If a serious imbalance of dependent parameter occurs from a low frequency of favorable responder, the descriptive analysis will be applied with T-test and Fisher's exact test.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult asthmatic patients(Duration of accumulated data electronic medical records)
Key inclusion criteria (9 listed)
- Codes for asthma (ICD-10: J45) dependent on availability
- Aged 18-80 years at index date
- Active asthma, defined as ≥ 1 prescriptions for LABA/ICS during baseline periods
- un-controlled asthma during the baseline period Any one of three criteria A. Asthma exacerbation B. Asthma-related ER visit/Hospitalization C. Physician defined un-controlled asthma
Key exclusion criteria (1 listed)
- taken biologics during baseline and outcome period
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 |
|---|---|---|
| OmalizumabAlso: Xolaircomparision of using Omalizumab and non-Omalizumab treatment | Other | – |
Primary outcome
asthma exacerbation rate
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2016.
- Individual participant dataSharing planned: Undecided
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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.
Hae-sim Park, Ph.D. principal investigator
Ajou University School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Ajou University School of Medicine.
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 9 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: status not confirmed, as of the sponsor's last update on 3 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
asthma exacerbation rate (time frame: one year). 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 3 Oct 2016.