Asthma
Conditions
Brief summary
This study is a single-center, retrospective, cross-sectional study. It plan to investigate the predictors for asthma exacerbation in long term follow up real world management with analyzing big data of electronic medical records (EMR).
Detailed description
The long-term goals of asthma treatment are to achieve well control of symptoms and to minimize the future risk of asthma exacerbations (AEs). Asthma is a heterogeneous disease with various responses to treatment and clinical outcomes. AEs are a prominent feature of severe asthmatics; however, frequent AEs have also been reported in mild asthmatics. This is a prospectively designed observational study to identify predictors for patients with frequent AEs among adult asthmatics by analyzing medical big data of electronic medical records (EMR), which will provide an insight in the long-term management of adult asthmatics in real-world practice.
Interventions
None listed
Sponsors
Novartis Korea Ltd.
Hae-Sim Park
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged ≥17 years * Patients having bronchial asthma with J45-J46 code of International classification of Diseases (10th edition on EMR) * Asthmatics who had been treated by allergy or respiratory specialists
Exclusion criteria
* Patients who has less than one year for asthma treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identifying prognostic factors for risk of severe asthma exacerbation | During the initial 2 years | Identifying prognostic factors for risk of severe asthma exacerbation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluating peripheral eosiniphil, neutrophil, basophil and lymphocyte counts to predict severe asthma exacerbation | During 10 years of treatment | Unit of peripheral eosiniphil, neutrophil, basophil and lymphocyte counts: ×10³/uL |
| Evaluating ECP (ug/L) to predict severe asthma exacerbation | During 10 years of treatment | Evaluating ECP (ug/L) to predict severe asthma exacerbation |
| Evaluating sputum eosinophils (%) to predict severe asthma exacerbation | During 10 years of treatment | Evaluating sputum eosinophils (%) to predict severe asthma exacerbation |
| Evaluating total IgE (KU/L) to predict severe asthma exacerbation | During 10 years of treatment | Evaluating total IgE (KU/L) to predict severe asthma exacerbation |
| Comparing clinical characteristics according to the frequency of severe asthma exacerbation | During the initial 2 years | Comparing clinical characteristics according to the frequency of severe asthma exacerbation |
| Sensitivity and specificity of predictors | during the initial 2 years and the following 3-10 years of treatment | Sensitivity and specificity of predictors |
| Evaluating FEV1 (%) and FEV1/FVC (%) to predict severe asthma exacerbation | During 10 years of treatment | Evaluating FEV1 (%) and FEV1/FVC (%) to predict severe asthma exacerbation |
Countries
South Korea
Outcome results
None listed