AsthmaNCT04479501
Retrospective Review on Patients With Recurrent Asthmatic Attacks Requiring Hospitalizations
An observational study of Asthma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Asthma exacerbation related hospitalization
- How many people
- 2,280 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- All patients with hospitalization for asthmatic exacerbation according to physician's clinical judgement
- Age greater than 18 years old
Who cannot join
- Inappropriate diagnosis of asthma exacerbation after evaluation
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Asthma is a common respiratory disease worldwide and in Hong Kong. According to the estimation by the Center for Disease Control and Prevention in 2015, 7.6% adults in the United States have asthma. In Hong Kong, the prevalence of asthma was estimated to be 10.1% among 13 to 14 years old children and 5.8% in randomly selected Chinese elderly aged more than 70. The clinical characteristics varies in different age groups, with elderly asthmatics have higher rates of bronchial hyper-reactivity and more severe phenotypes, when comparing with younger patients. This is more important in an ageing population.
Asthmatic exacerbation is not an uncommon complication and can be fatal. For those patients with near-fatal asthma exacerbation, ICU admission and mechanical ventilation may be necessary to prevent mortality. This is more common among poor controllers and adults. Asthma-related deaths may be reduced if risk factors are recognized and addressed early.
Many predictors for exacerbation had been identified, both endogenous and exogenous, including high eosinophil count, upper airway diseases, gastroesophageal reflux, poor inhaler technique, medication non-compliance, guideline non-compliance. One of the most powerful predictors for future exacerbation in patients with severe or difficult-to-treat asthma is a recent severe asthma exacerbation. In addition, hospitalization for exacerbations requiring ICU care and mechanical ventilation are both predictors for near-fatal asthma. After the acute attack, its unfavourable impact continues and can lead to multiple sequelae. Exacerbation of asthma is associated with a more rapid decline in the post-bronchodilator forced expiratory volume in 1 second and worse quality of life. In addition, individuals with uncontrolled asthma had higher medical expenditures and decreased productivity, contributing to a greater economic burden when compared with individuals without asthma. In contrary, patients with controlled asthma had lower hospitalization rate, mortality rate and less decline in lung function.
Many of these factors are potentially reversible. But, there is still a significant proportion of asthma patients experiencing recurrent exacerbation despite optimization of pharmacological treatment. A model of better asthma care may be established by improving the understanding on these risk factors, leading to less exacerbation events.
- Conditions
- Asthma
- Being tested
- Asthma exacerbation related hospitalization
- Keywords
- Asthma, Asthma exacerbation, Asthma hospitalization, Asthma control, Asthma care
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asthma exacerbation related hospitalizationOther
Evaluate the difference between patients with single and multiple hospitalizations for asthma exacerbation
| Study group | Role | What they receive |
|---|---|---|
| Asthma group | Patients with asthma Receives: Other: Asthma exacerbation related hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who had hospitalization for asthma attack
Number of patients who had hospitalization for asthma attack
Measured: 1 year
Secondary outcomes (4)
Burden of comorbidity among subjects with recurrent hospital admission for asthma attack
Burden of comorbidity among subjects with recurrent hospital admission for asthma attack
Measured: 1 year
Spirometric parameters (FEV1, FVC) among subjects with recurrent hospital admission for asthma attack
Spirometric parameters (FEV1, FVC) among subjects with recurrent hospital admission for asthma attack
Measured: 1 year
Baseline blood eosinophil among subjects with recurrent hospital admission for asthma attack
Baseline blood eosinophil among subjects with recurrent hospital admission for asthma attack
Measured: 1 year
Prevalence of asthma patients who had received phenotypic workup
Prevalence of asthma patients who had received phenotypic workup
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start1 Dec 2017
- Primary completion30 Jun 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- United Christian Hospital, Princess Margaret Hospital, Hong Kong, Pamela Youde Nethersole Eastern Hospital, Queen Elizabeth Hospital, Hong Kong, Queen Mary Hospital, Hong Kong, Kwong Wah Hospital, Tseung Kwan O Hospital, Hong Kong, Caritas Medical Centre, Hong Kong, North District Hospital, Alice Ho Miu Ling Nethersole Hospital
- Responsible party
- Principal investigator, Ka Pang Chan, Chinese University of Hong Kong
- Investigators
- Ka Pang Chan, MBChB, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479501
- Sponsor's protocol ID
- CREC 2017.503
- Status last verified
- Jul 2020
- First submitted
- 28 Jun 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
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.
PubMed 24003381Ko 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.
PubMed 16446081Pasha 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.
PubMed 28441988Romagnoli 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.
PubMed 17430352Miller 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.
PubMed 16914299Dougherty 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.
PubMed 19187331Zeiger 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.
PubMed 27665383Price 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.
PubMed 26493938ten 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.
PubMed 16264041Engelkes 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.
PubMed 25323234Nestor 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.
PubMed 9809496Williams 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.
PubMed 22019090Hasegawa 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.
PubMed 25439365Serrano-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.
PubMed 27870665Turner 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.
PubMed 9620909
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Review on Patients With Recurrent Asthmatic Attacks Requiring Hospitalizations
- ClinicalTrials.gov ID
- NCT04479501
- Acronym / sponsor ID
- CREC 2017.503
- Conditions
- Asthma
- Keywords
- Asthma, Asthma exacerbation, Asthma hospitalization, Asthma control, Asthma care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,280 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- United Christian Hospital, Princess Margaret Hospital, Hong Kong, Pamela Youde Nethersole Eastern Hospital, Queen Elizabeth Hospital, Hong Kong, Queen Mary Hospital, Hong Kong, Kwong Wah Hospital, Tseung Kwan O Hospital, Hong Kong, Caritas Medical Centre, Hong Kong, North District Hospital, Alice Ho Miu Ling Nethersole Hospital
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Asthma is a common respiratory disease worldwide and in Hong Kong. According to the estimation by the Center for Disease Control and Prevention in 2015, 7.6% adults in the United States have asthma. In Hong Kong, the prevalence of asthma was estimated to be 10.1% among 13 to 14 years old children and 5.8% in randomly selected Chinese elderly aged more than 70. The clinical characteristics varies in different age groups, with elderly asthmatics have higher rates of bronchial hyper-reactivity and more severe phenotypes, when comparing with younger patients. This is more important in an ageing population.
Asthmatic exacerbation is not an uncommon complication and can be fatal. For those patients with near-fatal asthma exacerbation, ICU admission and mechanical ventilation may be necessary to prevent mortality. This is more common among poor controllers and adults. Asthma-related deaths may be reduced if risk factors are recognized and addressed early.
Many predictors for exacerbation had been identified, both endogenous and exogenous, including high eosinophil count, upper airway diseases, gastroesophageal reflux, poor inhaler technique, medication non-compliance, guideline non-compliance. One of the most powerful predictors for future exacerbation in patients with severe or difficult-to-treat asthma is a recent severe asthma exacerbation. In addition, hospitalization for exacerbations requiring ICU care and mechanical ventilation are both predictors for near-fatal asthma. After the acute attack, its unfavourable impact continues and can lead to multiple sequelae. Exacerbation of asthma is associated with a more rapid decline in the post-bronchodilator forced expiratory volume in 1 second and worse quality of life. In addition, individuals with uncontrolled asthma had higher medical expenditures and decreased productivity, contributing to a greater economic burden when compared with individuals without asthma. In contrary, patients with controlled asthma had lower hospitalization rate, mortality rate and less decline in lung function.
Many of these factors are potentially reversible. But, there is still a significant proportion of asthma patients experiencing recurrent exacerbation despite optimization of pharmacological treatment. A model of better asthma care may be established by improving the understanding on these risk factors, leading to less exacerbation events.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthma group | – | Other: Asthma exacerbation related hospitalizationPatients with asthma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- All patients with hospitalization for asthmatic exacerbation according to physician's clinical judgement
- Age greater than 18 years old
Key exclusion criteria (1 listed)
- Inappropriate diagnosis of asthma exacerbation after evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asthma exacerbation related hospitalizationEvaluate the difference between patients with single and multiple hospitalizations for asthma exacerbation | Other | Asthma group |
Primary outcome
Number of patients who had hospitalization for asthma attack
Time frame: 1 year
Number of patients who had hospitalization for asthma attack
4 secondary outcomes
Burden of comorbidity among subjects with recurrent hospital admission for asthma attack
Time frame: 1 year
Spirometric parameters (FEV1, FVC) among subjects with recurrent hospital admission for asthma attack
Time frame: 1 year
Baseline blood eosinophil among subjects with recurrent hospital admission for asthma attack
Time frame: 1 year
Prevalence of asthma patients who had received phenotypic workup
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Background: PubMed 24003381Wong 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.
- Background: PubMed 16446081Ko 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.
- Background: PubMed 28441988Pasha 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.
- Background: PubMed 17430352Romagnoli 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.
- Background: PubMed 16914299Miller 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.
- Background: PubMed 19187331Dougherty 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.
- Background: PubMed 27665383Zeiger 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.
- Background: PubMed 26493938Price 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.
- Background: PubMed 16264041ten 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.
- Background: PubMed 25323234Engelkes 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.
- Background: PubMed 9809496Nestor 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.
- Background: PubMed 22019090Williams 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.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ka Pang Chan, MBChB principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who had hospitalization for asthma attack (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04479501, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.