Clinical trial NCT04563988: Factors for Predicting Severe Asthma Exacerbators in Adult Asthmatics: A Real Word- Effectiveness Study
Official title: Factors for Predicting Severe Asthma Exacerbators in Adult Asthmatics: A Real Word- Effectiveness Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
Collaborators: name: Novartis Korea Ltd.
First posted: 2020-09-25
Enrollment: 5058
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged ≥17 years diagnosed as having bronchial asthma (with J45-J46 code of International classification of Diseases, 10th edition on EMR) and who had been treated by allergy or respiratory specialists at Ajou University Hospital from January 1995 to June 2018

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.

Eligibility criteria: 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

Primary outcomes:
measure: Identifying prognostic factors for risk of severe asthma exacerbation
timeFrame: During the initial 2 years
Secondary outcomes:
measure: Evaluating total IgE (KU/L) to predict severe asthma exacerbation
timeFrame: During 10 years of treatment
measure: Evaluating peripheral eosiniphil, neutrophil, basophil and lymphocyte counts to predict severe asthma exacerbation
timeFrame: During 10 years of treatment
measure: Evaluating ECP (ug/L) to predict severe asthma exacerbation
timeFrame: During 10 years of treatment
measure: Evaluating sputum eosinophils (%) to predict severe asthma exacerbation
timeFrame: During 10 years of treatment
measure: Evaluating FEV1 (%) and FEV1/FVC (%) to predict severe asthma exacerbation
timeFrame: During 10 years of treatment
measure: Comparing clinical characteristics according to the frequency of severe asthma exacerbation
timeFrame: During the initial 2 years
measure: Sensitivity and specificity of predictors
timeFrame: during the initial 2 years and the following 3-10 years of treatment
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University School of Medicine
Study officials:
affiliation: Ajou University School of Medicine
name: Hae-sim Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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