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

NCT04563988 | Completed

• 1 other identifier: AJIRB-MED-MDB-18-291
• Study Type: observational
• Target: 5,058
• Locations: 1 country
• Sites: 1

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).

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Identifying prognostic factors for risk of severe asthma exacerbation

  Identifying prognostic factors for risk of severe asthma exacerbation

  During the initial 2 years

Secondary Outcomes (7)

• 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

  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

  During 10 years of treatment

• Evaluating FEV1 (%) and FEV1/FVC (%) to predict severe asthma exacerbation

  During 10 years of treatment

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Patients who has less than one year for asthma treatment

Sponsors & Collaborators

• Hae-Sim Park: lead
• Novartis Korea Ltd.: collaborator

Study Sites (1)

Ajou University School of Medicine

Suwon, South Korea

Location

Related Publications (9)

• 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.

  PMID: 23635528 BACKGROUND

• 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.

  PMID: 19535666 BACKGROUND

• 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.

  PMID: 18508818 BACKGROUND

• 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.

  PMID: 27057795 BACKGROUND

• 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.

  PMID: 26574724 BACKGROUND

• 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.

  PMID: 27215497 BACKGROUND

• 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.

  PMID: 25213045 BACKGROUND

• 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.

  PMID: 23505637 BACKGROUND

• 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.

  PMID: 26706728 BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• Hae-sim Park, MD, PhD

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator, Clinical professor, Department of Allergy and Clinical Immunology

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 25, 2020
• Study Start: October 22, 2018
• Primary Completion: April 25, 2019
• Study Completion: February 20, 2020
• Last Updated: September 25, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)