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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04563988
Recruitment Status : Completed
First Posted : September 25, 2020
Last Update Posted : September 25, 2020
Sponsor:
Collaborator:
Novartis Korea Ltd.
Information provided by (Responsible Party):
Hae-Sim Park, Ajou University School of Medicine

Study Description
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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).

Condition or disease
Asthma

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 Design
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Study Type : Observational
Actual Enrollment : 5058 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Factors for Predicting Severe Asthma Exacerbators in Adult Asthmatics: A Real Word- Effectiveness Study
Actual Study Start Date : October 22, 2018
Actual Primary Completion Date : April 25, 2019
Actual Study Completion Date : February 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04563988


Locations
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Korea, Republic of
Ajou University School of Medicine
Suwon, Korea, Republic of
Sponsors and Collaborators
Hae-Sim Park
Novartis Korea Ltd.
Investigators
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Principal Investigator: Hae-sim Park, MD, PhD Ajou University School of Medicine
More Information
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Publications:

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Responsible Party: Hae-Sim Park, Principal investigator, Clinical professor, Department of Allergy and Clinical Immunology, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT04563988    
Other Study ID Numbers: AJIRB-MED-MDB-18-291
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases