AsthmaNCT03239431
A Study to Determine the Clinical Characteristics, Comorbidities, Treatment Status and Exacerbations of Asthma Patients
An observational study of Asthma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a prospective cohort study that aims to determine the current demographics, clinical characteristics, comorbidities, treatment status and exacerbations of asthma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- asthmatic exacerbation
- How many people
- 400 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Sep 2017to 31 Jan 2022
- How long will I take part?
- 3 Years
- 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: Patients are recruited from the medical out-patient clinic by the physicians in the Prince of Wales Hospital. As the physicians will both attend general medical clinics and respiratory clinics, they will recruit patients from these clinics
Who may be able to join
- All patients with confirmed diagnosis of asthma (defined as those with a consistent history and prior documented evidence of variable airflow obstruction, with evidence of an increase in FEV1 greater than 12% or 200 mL following bronchodilator or bronchial hyperresponsiveness on bronchial provocation testing, when stable (reference)
- Age greater than 18 years old
- Signed written informed consent to participate in the study
Who cannot join
- Patients currently with acute exacerbation of asthma by GINA guideline (they can join the study after 6 weeks post recovery from the exacerbation)
- Patients with respiratory diseases that can show similar symptoms to asthma such as bronchiectasis, tuberculosis-destroyed lung parenchyma, endobronchial TB, and lung cancer, or those who have history of these diseases based on physician's judgment
- Patients with respiratory diseases that may confound the lung function parameters such as pleural diseases, interstitial lung diseases, and previous lung surgery, or those who have history of these diseases based on physician's judgment
- Patients with neuromuscular diseases that may affect the seal off the mouthpiece during spirometry and forced oscillometry technique (FOT)
- Patients with uncontrolled or active contagious respiratory infection diseases
- Patients with smoking history more than 10 pack years
Show all 10Show fewer
- Significant comorbid illnesses that limit the life expectancy to less than 1 year
- Patients who are mentally not fit or physically contraindicated for spirometry and FOT
- Patients with psychiatric disease or cognitive impairment that may limit their ability of understanding or giving consent to the study
- Patients currently randomized in other clinical studies
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Chinese University of Hong Kong
Hong Kong
Ka Pang Chan, MBChB, 852 3505 3396, chankapang@gmail.com
Fanny WS Ko, MBChB, MD, 852 3505 3396, fannyko@cuhk.edu.hk
About this study
Official title: A 3 Year Longitudinal Study of the Level of Asthma Control and Treatment of Asthma Patients in Hong Kong
This is a prospective cohort study that aims to determine the current demographics, clinical characteristics, comorbidities, treatment status and exacerbations of asthma patients.
The primary objective of this study is to determine the current demographics, clinical characteristics, comorbidities, treatment status and exacerbations of asthma patients.
Read more
The secondary objectives include: (1) to review the current practices of symptom control assessment, (2) to determine the choice of pharmacological regimen, rate of guideline adherence and real-world clinical practice in managing asthma patients, (3) to evaluate the pattern of lung function parameters (spirometry and forced oscillometry technique [FOT]) in adult asthma patients, (4) to evaluate the effect of ageing on the trend of change in lung function parameters (spirometry and FOT) in adult asthma patients, (5) to identify biomarkers that help to categorize different asthma phenotypes and predict subsequent prognosis, (6) to determine the risk factors of uncontrolled asthma and asthma exacerbation, (7) to evaluate the impact of comorbidities on asthma control.
400 out-patient asthma patients are planned to be recruited and they will be followed up for 3 years.
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. With a rising trend of life expectancy in Hong Kong, the epidemiology of asthma in adult and elderly population may change over time. In addition, elderly patients with asthma may present with a different spectrum of clinical characteristics and pharmacological response.
Asthmatic exacerbation is one of the untoward complications and 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. Without adjustment of medical treatment, they are prone to develop another episode of exacerbation within a short period of time. 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 lung function decline. Many risk factors for exacerbation had been identified including upper airway diseases, gastroesophageal reflux, poor inhaler technique, medication non-compliance. Many of these factors are potentially reversible. A model of better asthma care may be established by improving the understanding on these risk factors, leading to less exacerbation events.
Asthma is not simply an airway disease. Accumulating evidence showed its coexistence with other upper airway and systemic diseases, both atopic and non-atopic. These comorbidities independently or linked together to impose negative impact on patients' health status and quality of life. Knowing about the burden of asthma related comorbidities may help to guide clinician in managing these complications in a more effective way, and even prediction of subsequent prognosis.
Since the launching of GINA guideline in year 1993, its regular evidence-based update on pharmacological treatment had revolutionize the care of asthma patients. The use of asthma medications by both specialists and primary care physicians became more structured and the asthma control was improved. However, there is still a significant proportion of asthma patients experiencing recurrent exacerbation despite optimization of pharmacological treatment. Both the guideline adherence by physicians and drug compliance by patient are subjects of concern.
Previous evidence showed that the compliance rate of GINA guideline is far from satisfactory, which is a shared phenomenon among different common diseases even the presence of well-established international guideline. Patient's drug compliance also contributes to negative disease outcome, especially non-adherence to inhaled corticosteroid. Currently, a comprehensive view on the treatment status in and level of asthma control in Hong Kong is still lacking.
A large knowledge gap exists between the current demographics, comorbidities, treatment status, level of asthma control and exacerbations in Hong Kong. An updated study on these aspects is definitely warranted to enhance patient care and guide further research.
- Conditions
- Asthma
- Being tested
- asthmatic exacerbation
- Keywords
- asthma, lung function, forced oscillometry technique, exacerbation
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
asthmatic exacerbationOther
evaluate the risk factors, frequency and nature of asthma exacerbations
| Study group | Role | What they receive |
|---|---|---|
| Asthma group | Patients with asthma Receives: Other: asthmatic exacerbation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The clinical characteristics of asthma patients
The clinical characteristics of asthma patients
Measured: over 3 years
The treatment status of asthma patients
The treatment status of asthma patients
Measured: over 3 years
Secondary outcomes (3)
The 3 year morbidity of asthma patients
The 3 year morbidity of asthma patients
Measured: over 3 years
The 3 year mortality of asthma patients
The 3 year mortality of asthma patients
Measured: over 3 years
Genetic markers that predict exacerbation
Genetic markers in blood sample that can help to predict exacerbation and level of control in patients with asthma
Measured: over 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start15 Sep 2017
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)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
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- 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
- NCT03239431
- Sponsor's protocol ID
- CREC 2017.336
- Status last verified
- Jan 2019
- First submitted
- 27 Jul 2017
- Last updated
- 31 Jan 2019
- 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 28441988Serrano-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 9620909Bai 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.
PubMed 17537763O'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.
PubMed 18990678Luskin 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.
PubMed 25213047Miller 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 16914299Sullivan 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.
PubMed 24697738Moorman 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.
PubMed 24252609ten 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 25323234Tay TR, Radhakrishna N, Hore-Lacy F, Smith C, Hoy R, Dabscheck E, Hew M. Comorbidities in difficult asthma are independent risk factors for frequent exacerbations, poor control and diminished quality of life. Respirology. 2016 Nov;21(8):1384-1390. doi: 10.1111/resp.12838. Epub 2016 Jul 1.
PubMed 27363539Boulet LP. Influence of comorbid conditions on asthma. Eur Respir J. 2009 Apr;33(4):897-906. doi: 10.1183/09031936.00121308.
PubMed 19336592
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3 Year Longitudinal Study of the Level of Asthma Control and Treatment of Asthma Patients in Hong Kong
- ClinicalTrials.gov ID
- NCT03239431
- Acronym / sponsor ID
- CREC 2017.336
- Conditions
- Asthma
- Keywords
- asthma, lung function, forced oscillometry technique, exacerbation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 4 Aug 2017 (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.
This is a prospective cohort study that aims to determine the current demographics, clinical characteristics, comorbidities, treatment status and exacerbations of asthma patients.
The primary objective of this study is to determine the current demographics, clinical characteristics, comorbidities, treatment status and exacerbations of asthma patients.
The secondary objectives include: (1) to review the current practices of symptom control assessment, (2) to determine the choice of pharmacological regimen, rate of guideline adherence and real-world clinical practice in managing asthma patients, (3) to evaluate the pattern of lung function parameters (spirometry and forced oscillometry technique [FOT]) in adult asthma patients, (4) to evaluate the effect of ageing on the trend of change in lung function parameters (spirometry and FOT) in adult asthma patients, (5) to identify biomarkers that help to categorize different asthma phenotypes and predict subsequent prognosis, (6) to determine the risk factors of uncontrolled asthma and asthma exacerbation, (7) to evaluate the impact of comorbidities on asthma control.
400 out-patient asthma patients are planned to be recruited and they will be followed up for 3 years.
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. With a rising trend of life expectancy in Hong Kong, the epidemiology of asthma in adult and elderly population may change over time. In addition, elderly patients with asthma may present with a different spectrum of clinical characteristics and pharmacological response.
Asthmatic exacerbation is one of the untoward complications and 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. Without adjustment of medical treatment, they are prone to develop another episode of exacerbation within a short period of time. 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 lung function decline. Many risk factors for exacerbation had been identified including upper airway diseases, gastroesophageal reflux, poor inhaler technique, medication non-compliance. Many of these factors are potentially reversible. A model of better asthma care may be established by improving the understanding on these risk factors, leading to less exacerbation events.
Asthma is not simply an airway disease. Accumulating evidence showed its coexistence with other upper airway and systemic diseases, both atopic and non-atopic. These comorbidities independently or linked together to impose negative impact on patients' health status and quality of life. Knowing about the burden of asthma related comorbidities may help to guide clinician in managing these complications in a more effective way, and even prediction of subsequent prognosis.
Since the launching of GINA guideline in year 1993, its regular evidence-based update on pharmacological treatment had revolutionize the care of asthma patients. The use of asthma medications by both specialists and primary care physicians became more structured and the asthma control was improved. However, there is still a significant proportion of asthma patients experiencing recurrent exacerbation despite optimization of pharmacological treatment. Both the guideline adherence by physicians and drug compliance by patient are subjects of concern.
Previous evidence showed that the compliance rate of GINA guideline is far from satisfactory, which is a shared phenomenon among different common diseases even the presence of well-established international guideline. Patient's drug compliance also contributes to negative disease outcome, especially non-adherence to inhaled corticosteroid. Currently, a comprehensive view on the treatment status in and level of asthma control in Hong Kong is still lacking.
A large knowledge gap exists between the current demographics, comorbidities, treatment status, level of asthma control and exacerbations in Hong Kong. An updated study on these aspects is definitely warranted to enhance patient care and guide further research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthma group | – | Other: asthmatic exacerbationPatients with asthma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are recruited from the medical out-patient clinic by the physicians in the Prince of Wales Hospital. As the physicians will both attend general medical clinics and respiratory clinics, they will recruit patients from these clinics
Key inclusion criteria (3 listed)
- All patients with confirmed diagnosis of asthma (defined as those with a consistent history and prior documented evidence of variable airflow obstruction, with evidence of an increase in FEV1 greater than 12% or 200 mL following bronchodilator or bronchial hyperresponsiveness on bronchial provocation testing, when stable (reference)
- Age greater than 18 years old
- Signed written informed consent to participate in the study
Key exclusion criteria (10 listed)
- Patients currently with acute exacerbation of asthma by GINA guideline (they can join the study after 6 weeks post recovery from the exacerbation)
- Patients with respiratory diseases that can show similar symptoms to asthma such as bronchiectasis, tuberculosis-destroyed lung parenchyma, endobronchial TB, and lung cancer, or those who have history of these diseases based on physician's judgment
- Patients with respiratory diseases that may confound the lung function parameters such as pleural diseases, interstitial lung diseases, and previous lung surgery, or those who have history of these diseases based on physician's judgment
- Patients with neuromuscular diseases that may affect the seal off the mouthpiece during spirometry and forced oscillometry technique (FOT)
- Patients with uncontrolled or active contagious respiratory infection diseases
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 |
|---|---|---|
| asthmatic exacerbationevaluate the risk factors, frequency and nature of asthma exacerbations | Other | Asthma group |
Primary outcome
The clinical characteristics of asthma patients
Time frame: over 3 years
The clinical characteristics of asthma patients
The treatment status of asthma patients
Time frame: over 3 years
The treatment status of asthma patients
3 secondary outcomes
The 3 year morbidity of asthma patients
Time frame: over 3 years
The 3 year mortality of asthma patients
Time frame: over 3 years
Genetic markers that predict exacerbation
Time frame: over 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- 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 27870665Serrano-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.
- Background: PubMed 9620909Turner 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.
- Background: PubMed 17537763Bai 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.
- Background: PubMed 18990678O'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.
- Background: PubMed 25213047Luskin 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.
- 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 24697738Sullivan 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.
- Background: PubMed 24252609Moorman 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.
- 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.
- 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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 31 Jan 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ka Pang Chan, MBChB (852 3505 3396, chankapang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clinical characteristics of asthma patients (time frame: over 3 years). The study lists 2 primary outcomes in all. 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 NCT03239431, which also lists 26 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 31 Jan 2019.