Factors for Predicting Severe Asthma Exacerbators in Adult Asthmatics: A Real Word- Effectiveness Study

Completed

• Conditions: Asthma

• Registration Number: NCT04563988
• Lead Sponsor: Hae-Sim Park

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.

Study Timeline

• Study Start: 2018-10-22
• Primary Completion: 2019-04-25
• Study Completion: 2020-02-20
• Study First Submitted: 2020-08-31
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-23
• Last Update Submitted: 2020-09-23
• Study First Posted: 2020-09-25
• Last Update Posted: 2020-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5058

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identifying prognostic factors for risk of severe asthma exacerbation	During the initial 2 years	Identifying prognostic factors for risk of severe asthma exacerbation

Secondary Outcome Measures

Name	Time	Method
Evaluating ECP (ug/L) to predict severe asthma exacerbation	During 10 years of treatment	Evaluating ECP (ug/L) to predict 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 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 total IgE (KU/L) to predict severe asthma exacerbation	During 10 years of treatment	Evaluating total IgE (KU/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 FEV1 (%) and FEV1/FVC (%) to predict severe asthma exacerbation	During 10 years of treatment	Evaluating FEV1 (%) and FEV1/FVC (%) 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

Trial Locations

Locations (1)

Ajou University School of Medicine; 🇰🇷 Suwon, Korea, Republic of