Asthma Clinical Trial
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.
1. 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)
1. Within Omalizumab-treated group between baseline and outcome period
2. 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.
;
Observational Model: Cohort, Time Perspective: Retrospective
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