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

September 23, 2020 updated by: Hae-Sim Park
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).

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

5058

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identifying prognostic factors for risk of severe asthma exacerbation
Time Frame: During the initial 2 years
Identifying prognostic factors for risk of severe asthma exacerbation
During the initial 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluating total IgE (KU/L) to predict severe asthma exacerbation
Time Frame: During 10 years of treatment
Evaluating total IgE (KU/L) to predict severe asthma exacerbation
During 10 years of treatment
Evaluating peripheral eosiniphil, neutrophil, basophil and lymphocyte counts to predict severe asthma exacerbation
Time Frame: During 10 years of treatment
Unit of peripheral eosiniphil, neutrophil, basophil and lymphocyte counts: ×10³/uL
During 10 years of treatment
Evaluating ECP (ug/L) to predict severe asthma exacerbation
Time Frame: During 10 years of treatment
Evaluating ECP (ug/L) to predict severe asthma exacerbation
During 10 years of treatment
Evaluating sputum eosinophils (%) to predict severe asthma exacerbation
Time Frame: During 10 years of treatment
Evaluating sputum eosinophils (%) to predict severe asthma exacerbation
During 10 years of treatment
Evaluating FEV1 (%) and FEV1/FVC (%) to predict severe asthma exacerbation
Time Frame: During 10 years of treatment
Evaluating FEV1 (%) and FEV1/FVC (%) to predict severe asthma exacerbation
During 10 years of treatment
Comparing clinical characteristics according to the frequency of severe asthma exacerbation
Time Frame: During the initial 2 years
Comparing clinical characteristics according to the frequency of severe asthma exacerbation
During the initial 2 years
Sensitivity and specificity of predictors
Time Frame: during the initial 2 years and the following 3-10 years of treatment
Sensitivity and specificity of predictors
during the initial 2 years and the following 3-10 years of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hae-Sim Park

Collaborators

Novartis Korea Ltd.

Investigators

  • Principal Investigator: Hae-sim Park, MD, PhD, Ajou University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2018

Primary Completion (Actual)

April 25, 2019

Study Completion (Actual)

February 20, 2020

Study Registration Dates

First Submitted

August 31, 2020

First Submitted That Met QC Criteria

September 23, 2020

First Posted (Actual)

September 25, 2020

Study Record Updates

Last Update Posted (Actual)

September 25, 2020

Last Update Submitted That Met QC Criteria

September 23, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJIRB-MED-MDB-18-291

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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