NCT04479501

Brief Summary

Asthma is a common respiratory disease. around the world. Asthma exacerbation is one of the major sequelae and associated with various morbidity and mortality. A satisfactory asthma control can help to bring down the risk of exacerbation and hence hospitalization. However, the real-world evidence on the clinical factors that leads to multiple admissions, when compared with single admission, due to asthma exacerbation is scarce. This study aimed at evaluating the clinical characteristics of patients who had single and multiple hospitalizations for asthma exacerbations, and exploring the risk factors that predict multiple hospitalizations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

1.6 years

First QC Date

June 28, 2020

Last Update Submit

July 16, 2020

Conditions

Keywords

AsthmaAsthma exacerbationAsthma hospitalizationAsthma controlAsthma care

Outcome Measures

Primary Outcomes (1)

  • Number of patients who had hospitalization for asthma attack

    Number of patients who had hospitalization for asthma attack

    1 year

Secondary Outcomes (4)

  • Burden of comorbidity among subjects with recurrent hospital admission for asthma attack

    1 year

  • Spirometric parameters (FEV1, FVC) among subjects with recurrent hospital admission for asthma attack

    1 year

  • Baseline blood eosinophil among subjects with recurrent hospital admission for asthma attack

    1 year

  • Prevalence of asthma patients who had received phenotypic workup

    1 year

Study Arms (1)

Asthma group

Patients with asthma

Other: Asthma exacerbation related hospitalization

Interventions

Evaluate the difference between patients with single and multiple hospitalizations for asthma exacerbation

Asthma group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

By using the International Classification of Diseases, Ninth Revision, Clinical Modification code 493.xx, each participating hospital identified all primary hospital discharge diagnosis of asthma (exacerbation) during a 12-month period, between 1st January 2016 to 31st December 2016

You may qualify if:

  • All patients with hospitalization for asthmatic exacerbation according to physician's clinical judgement
  • Age greater than 18 years old

You may not qualify if:

  • \- Inappropriate diagnosis of asthma exacerbation after evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (24)

  • Wong GW, Leung TF, Ko FW. Changing prevalence of allergic diseases in the Asia-pacific region. Allergy Asthma Immunol Res. 2013 Sep;5(5):251-7. doi: 10.4168/aair.2013.5.5.251. Epub 2013 Mar 18.

    PMID: 24003381BACKGROUND
  • Ko FW, Lai CK, Woo J, Ho SC, Ho CW, Goggins W, Hui DS. 12-year change in prevalence of respiratory symptoms in elderly Chinese living in Hong Kong. Respir Med. 2006 Sep;100(9):1598-607. doi: 10.1016/j.rmed.2005.12.007. Epub 2006 Jan 30.

    PMID: 16446081BACKGROUND
  • Pasha MA, Sundquist B, Townley R. Asthma pathogenesis, diagnosis, and management in the elderly. Allergy Asthma Proc. 2017 May 1;38(3):184-191. doi: 10.2500/aap.2017.38.4048.

    PMID: 28441988BACKGROUND
  • Romagnoli M, Caramori G, Braccioni F, Ravenna F, Barreiro E, Siafakas NM, Vignola AM, Chanez P, Fabbri LM, Papi A; ENFUMOSA Study Group. Near-fatal asthma phenotype in the ENFUMOSA Cohort. Clin Exp Allergy. 2007 Apr;37(4):552-7. doi: 10.1111/j.1365-2222.2007.02683.x.

    PMID: 17430352BACKGROUND
  • Miller MK, Lee JH, Miller DP, Wenzel SE; TENOR Study Group. Recent asthma exacerbations: a key predictor of future exacerbations. Respir Med. 2007 Mar;101(3):481-9. doi: 10.1016/j.rmed.2006.07.005. Epub 2006 Aug 17.

    PMID: 16914299BACKGROUND
  • Dougherty RH, Fahy JV. Acute exacerbations of asthma: epidemiology, biology and the exacerbation-prone phenotype. Clin Exp Allergy. 2009 Feb;39(2):193-202. doi: 10.1111/j.1365-2222.2008.03157.x.

    PMID: 19187331BACKGROUND
  • Zeiger RS, Schatz M, Dalal AA, Chen W, Sadikova E, Suruki RY, Kawatkar AA, Qian L. Blood Eosinophil Count and Outcomes in Severe Uncontrolled Asthma: A Prospective Study. J Allergy Clin Immunol Pract. 2017 Jan-Feb;5(1):144-153.e8. doi: 10.1016/j.jaip.2016.07.015. Epub 2016 Sep 21.

    PMID: 27665383BACKGROUND
  • Price DB, Rigazio A, Campbell JD, Bleecker ER, Corrigan CJ, Thomas M, Wenzel SE, Wilson AM, Small MB, Gopalan G, Ashton VL, Burden A, Hillyer EV, Kerkhof M, Pavord ID. Blood eosinophil count and prospective annual asthma disease burden: a UK cohort study. Lancet Respir Med. 2015 Nov;3(11):849-58. doi: 10.1016/S2213-2600(15)00367-7. Epub 2015 Oct 19.

    PMID: 26493938BACKGROUND
  • ten Brinke A, Sterk PJ, Masclee AA, Spinhoven P, Schmidt JT, Zwinderman AH, Rabe KF, Bel EH. Risk factors of frequent exacerbations in difficult-to-treat asthma. Eur Respir J. 2005 Nov;26(5):812-8. doi: 10.1183/09031936.05.00037905.

    PMID: 16264041BACKGROUND
  • Engelkes M, Janssens HM, de Jongste JC, Sturkenboom MC, Verhamme KM. Medication adherence and the risk of severe asthma exacerbations: a systematic review. Eur Respir J. 2015 Feb;45(2):396-407. doi: 10.1183/09031936.00075614. Epub 2014 Oct 16.

    PMID: 25323234BACKGROUND
  • Nestor A, Calhoun AC, Dickson M, Kalik CA. Cross-sectional analysis of the relationship between national guideline recommended asthma drug therapy and emergency/hospital use within a managed care population. Ann Allergy Asthma Immunol. 1998 Oct;81(4):327-30. doi: 10.1016/S1081-1206(10)63124-9.

    PMID: 9809496BACKGROUND
  • Williams LK, Peterson EL, Wells K, Ahmedani BK, Kumar R, Burchard EG, Chowdhry VK, Favro D, Lanfear DE, Pladevall M. Quantifying the proportion of severe asthma exacerbations attributable to inhaled corticosteroid nonadherence. J Allergy Clin Immunol. 2011 Dec;128(6):1185-1191.e2. doi: 10.1016/j.jaci.2011.09.011. Epub 2011 Oct 21.

    PMID: 22019090BACKGROUND
  • Hasegawa K, Sullivan AF, Tovar Hirashima E, Gaeta TJ, Fee C, Turner SJ, Massaro S, Camargo CA Jr; Multicenter Airway Research Collaboration-36 Investigators. A multicenter observational study of US adults with acute asthma: who are the frequent users of the emergency department? J Allergy Clin Immunol Pract. 2014 Nov-Dec;2(6):733-40. doi: 10.1016/j.jaip.2014.06.012. Epub 2014 Sep 10.

    PMID: 25439365BACKGROUND
  • Serrano-Pariente J, Plaza V. Near-fatal asthma: a heterogeneous clinical entity. Curr Opin Allergy Clin Immunol. 2017 Feb;17(1):28-35. doi: 10.1097/ACI.0000000000000333.

    PMID: 27870665BACKGROUND
  • Turner MO, Noertjojo K, Vedal S, Bai T, Crump S, Fitzgerald JM. Risk factors for near-fatal asthma. A case-control study in hospitalized patients with asthma. Am J Respir Crit Care Med. 1998 Jun;157(6 Pt 1):1804-9. doi: 10.1164/ajrccm.157.6.9708092.

    PMID: 9620909BACKGROUND
  • Bai TR, Vonk JM, Postma DS, Boezen HM. Severe exacerbations predict excess lung function decline in asthma. Eur Respir J. 2007 Sep;30(3):452-6. doi: 10.1183/09031936.00165106. Epub 2007 May 30.

    PMID: 17537763BACKGROUND
  • O'Byrne PM, Pedersen S, Lamm CJ, Tan WC, Busse WW; START Investigators Group. Severe exacerbations and decline in lung function in asthma. Am J Respir Crit Care Med. 2009 Jan 1;179(1):19-24. doi: 10.1164/rccm.200807-1126OC. Epub 2008 Oct 31.

    PMID: 18990678BACKGROUND
  • Luskin AT, Chipps BE, Rasouliyan L, Miller DP, Haselkorn T, Dorenbaum A. Impact of asthma exacerbations and asthma triggers on asthma-related quality of life in patients with severe or difficult-to-treat asthma. J Allergy Clin Immunol Pract. 2014 Sep-Oct;2(5):544-52.e1-2. doi: 10.1016/j.jaip.2014.02.011. Epub 2014 Jul 3.

    PMID: 25213047BACKGROUND
  • Sullivan PW, Slejko JF, Ghushchyan VH, Sucher B, Globe DR, Lin SL, Globe G. The relationship between asthma, asthma control and economic outcomes in the United States. J Asthma. 2014 Sep;51(7):769-78. doi: 10.3109/02770903.2014.906607. Epub 2014 Apr 7.

    PMID: 24697738BACKGROUND
  • Moorman JE, Akinbami LJ, Bailey CM, Zahran HS, King ME, Johnson CA, Liu X. National surveillance of asthma: United States, 2001-2010. Vital Health Stat 3. 2012 Nov;(35):1-58.

    PMID: 24252609BACKGROUND
  • Heaney LG, Conway E, Kelly C, Johnston BT, English C, Stevenson M, Gamble J. Predictors of therapy resistant asthma: outcome of a systematic evaluation protocol. Thorax. 2003 Jul;58(7):561-6. doi: 10.1136/thorax.58.7.561.

    PMID: 12832665BACKGROUND
  • Robinson DS, Campbell DA, Durham SR, Pfeffer J, Barnes PJ, Chung KF; Asthma and Allergy Research Group of the National Heart and Lung Institute. Systematic assessment of difficult-to-treat asthma. Eur Respir J. 2003 Sep;22(3):478-83. doi: 10.1183/09031936.03.00017003.

    PMID: 14516138BACKGROUND
  • Hekking PW, Wener RR, Amelink M, Zwinderman AH, Bouvy ML, Bel EH. The prevalence of severe refractory asthma. J Allergy Clin Immunol. 2015 Apr;135(4):896-902. doi: 10.1016/j.jaci.2014.08.042. Epub 2014 Oct 16.

    PMID: 25441637BACKGROUND
  • Koga T, Oshita Y, Kamimura T, Koga H, Aizawa H. Characterisation of patients with frequent exacerbation of asthma. Respir Med. 2006 Feb;100(2):273-8. doi: 10.1016/j.rmed.2005.05.017. Epub 2005 Jul 5.

    PMID: 15998585BACKGROUND

Related Links

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Ka Pang Chan, MBChB

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honorary Clinical Tutor

Study Record Dates

First Submitted

June 28, 2020

First Posted

July 21, 2020

Study Start

December 1, 2017

Primary Completion

June 30, 2019

Study Completion

December 31, 2019

Last Updated

July 21, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Starting 6 months after publication
Access Criteria
upon individual approach for metaanalysis or related study

Locations