Skip to main content
OpenTrials
Completed

NCT Number: NCT04563988

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

17 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ajou University School of Medicine

Suwon, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Evaluating sputum eosinophils (%) to predict severe asthma exacerbation

    Time frame: During 10 years of treatment

    Evaluating sputum eosinophils (%) to predict severe asthma exacerbation

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Hae-Sim Park

Other

Collaborators

  • Novartis Korea Ltd.

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Sep 25, 2020
Registry last updated
Sep 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.