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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04563988
• Other study ID #: AJIRB-MED-MDB-18-291
• Status: Completed
• Start date: October 22, 2018
• Est. completion date: February 20, 2020

Study information

• Verified date: September 2020
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5058
• Est. completion date: February 20, 2020
• Est. primary completion date: April 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
Korea, Republic of	Ajou University School of Medicine	Suwon

Sponsors (2)

Lead Sponsor	Collaborator
Hae-Sim Park	Novartis Korea Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (9)

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

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