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

NCT ID: NCT04563988

Last Updated: 2020-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5058 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-22

Study Completion Date

2020-02-20

Brief Summary

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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

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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.

Conditions

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Asthma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Korea Ltd.

INDUSTRY

Sponsor Role collaborator

Hae-Sim Park

OTHER

Sponsor Role lead

Responsible Party

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Hae-Sim Park

Principal investigator, Clinical professor, Department of Allergy and Clinical Immunology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hae-sim Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ajou University School of Medicine

Locations

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Ajou University School of Medicine

Suwon, , South Korea

Site Status

Countries

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South Korea

References

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Greenberg S. Asthma exacerbations: predisposing factors and prediction rules. Curr Opin Allergy Clin Immunol. 2013 Jun;13(3):225-36. doi: 10.1097/ACI.0b013e32836096de.

Reference Type BACKGROUND
PMID: 23635528 (View on PubMed)

Reddel HK, Taylor DR, Bateman ED, Boulet LP, Boushey HA, Busse WW, Casale TB, Chanez P, Enright PL, Gibson PG, de Jongste JC, Kerstjens HA, Lazarus SC, Levy ML, O'Byrne PM, Partridge MR, Pavord ID, Sears MR, Sterk PJ, Stoloff SW, Sullivan SD, Szefler SJ, Thomas MD, Wenzel SE; American Thoracic Society/European Respiratory Society Task Force on Asthma Control and Exacerbations. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med. 2009 Jul 1;180(1):59-99. doi: 10.1164/rccm.200801-060ST.

Reference Type BACKGROUND
PMID: 19535666 (View on PubMed)

van Veen IH, Ten Brinke A, Sterk PJ, Sont JK, Gauw SA, Rabe KF, Bel EH. Exhaled nitric oxide predicts lung function decline in difficult-to-treat asthma. Eur Respir J. 2008 Aug;32(2):344-9. doi: 10.1183/09031936.00135907. Epub 2008 May 28.

Reference Type BACKGROUND
PMID: 18508818 (View on PubMed)

Bayes HK, Cowan DC. Biomarkers and asthma management: an update. Curr Opin Allergy Clin Immunol. 2016 Jun;16(3):210-7. doi: 10.1097/ACI.0000000000000263.

Reference Type BACKGROUND
PMID: 27057795 (View on PubMed)

Parulekar AD, Diamant Z, Hanania NA. Role of T2 inflammation biomarkers in severe asthma. Curr Opin Pulm Med. 2016 Jan;22(1):59-68. doi: 10.1097/MCP.0000000000000231.

Reference Type BACKGROUND
PMID: 26574724 (View on PubMed)

Buhl R, Korn S, Menzies-Gow A, Aubier M, Chapman KR, Canonica GW, Picado C, Martin N, Escobar RA, Korom S, Hanania NA. Assessing biomarkers in a real-world severe asthma study (ARIETTA). Respir Med. 2016 Jun;115:7-12. doi: 10.1016/j.rmed.2016.04.001. Epub 2016 Apr 14.

Reference Type BACKGROUND
PMID: 27215497 (View on PubMed)

Humbert M, Busse W, Hanania NA, Lowe PJ, Canvin J, Erpenbeck VJ, Holgate S. Omalizumab in asthma: an update on recent developments. J Allergy Clin Immunol Pract. 2014 Sep-Oct;2(5):525-36.e1. doi: 10.1016/j.jaip.2014.03.010. Epub 2014 Jun 11.

Reference Type BACKGROUND
PMID: 25213045 (View on PubMed)

Grimaldi-Bensouda L, Zureik M, Aubier M, Humbert M, Levy J, Benichou J, Molimard M, Abenhaim L; Pharmacoepidemiology of Asthma and Xolair (PAX) Study Group. Does omalizumab make a difference to the real-life treatment of asthma exacerbations?: Results from a large cohort of patients with severe uncontrolled asthma. Chest. 2013 Feb 1;143(2):398-405. doi: 10.1378/chest.12-1372.

Reference Type BACKGROUND
PMID: 23505637 (View on PubMed)

Zissler UM, Esser-von Bieren J, Jakwerth CA, Chaker AM, Schmidt-Weber CB. Current and future biomarkers in allergic asthma. Allergy. 2016 Apr;71(4):475-94. doi: 10.1111/all.12828. Epub 2016 Jan 18.

Reference Type BACKGROUND
PMID: 26706728 (View on PubMed)

Other Identifiers

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AJIRB-MED-MDB-18-291

Identifier Type: -

Identifier Source: org_study_id

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