Factors for Predicting Severe Asthma Exacerbators in Adult Asthmatics: A Real Word- Effectiveness Study
23. september 2020 opdateret af: Hae-Sim Park
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).
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
5058
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Suwon, Korea, Republikken
- Ajou University School of Medicine
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
17 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Identifying prognostic factors for risk of severe asthma exacerbation
Tidsramme: During the initial 2 years
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Identifying prognostic factors for risk of severe asthma exacerbation
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During the initial 2 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Evaluating total IgE (KU/L) to predict severe asthma exacerbation
Tidsramme: During 10 years of treatment
|
Evaluating total IgE (KU/L) to predict severe asthma exacerbation
|
During 10 years of treatment
|
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Evaluating peripheral eosiniphil, neutrophil, basophil and lymphocyte counts to predict severe asthma exacerbation
Tidsramme: During 10 years of treatment
|
Unit of peripheral eosiniphil, neutrophil, basophil and lymphocyte counts: ×10³/uL
|
During 10 years of treatment
|
|
Evaluating ECP (ug/L) to predict severe asthma exacerbation
Tidsramme: 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
Tidsramme: During 10 years of treatment
|
Evaluating sputum eosinophils (%) to predict severe asthma exacerbation
|
During 10 years of treatment
|
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Evaluating FEV1 (%) and FEV1/FVC (%) to predict severe asthma exacerbation
Tidsramme: During 10 years of treatment
|
Evaluating FEV1 (%) and FEV1/FVC (%) to predict severe asthma exacerbation
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During 10 years of treatment
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Comparing clinical characteristics according to the frequency of severe asthma exacerbation
Tidsramme: During the initial 2 years
|
Comparing clinical characteristics according to the frequency of severe asthma exacerbation
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During the initial 2 years
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Sensitivity and specificity of predictors
Tidsramme: during the initial 2 years and the following 3-10 years of treatment
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Sensitivity and specificity of predictors
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during the initial 2 years and the following 3-10 years of treatment
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Hae-sim Park, MD, PhD, Ajou University School of Medicine
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
22. oktober 2018
Primær færdiggørelse (Faktiske)
25. april 2019
Studieafslutning (Faktiske)
20. februar 2020
Datoer for studieregistrering
Først indsendt
31. august 2020
Først indsendt, der opfyldte QC-kriterier
23. september 2020
Først opslået (Faktiske)
25. september 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. september 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. september 2020
Sidst verificeret
1. september 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AJIRB-MED-MDB-18-291
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
There is not a plan to make IPD available.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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