Asthma Clinical Trial
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.
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.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | January 31, 2022 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. 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) 2. Age greater than 18 years old 3. Signed written informed consent to participate in the study Exclusion Criteria: 1. Patients currently with acute exacerbation of asthma by GINA guideline (they can join the study after 6 weeks post recovery from the exacerbation) 2. 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 3. 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 4. Patients with neuromuscular diseases that may affect the seal off the mouthpiece during spirometry and forced oscillometry technique (FOT) 5. Patients with uncontrolled or active contagious respiratory infection diseases 6. Patients with smoking history more than 10 pack years 7. Significant comorbid illnesses that limit the life expectancy to less than 1 year 8. Patients who are mentally not fit or physically contraindicated for spirometry and FOT 9. Patients with psychiatric disease or cognitive impairment that may limit their ability of understanding or giving consent to the study 10. Patients currently randomized in other clinical studies |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Chinese University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
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* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The clinical characteristics of asthma patients | The clinical characteristics of asthma patients | over 3 years | |
Primary | The treatment status of asthma patients | The treatment status of asthma patients | over 3 years | |
Secondary | The 3 year morbidity of asthma patients | The 3 year morbidity of asthma patients | over 3 years | |
Secondary | The 3 year mortality of asthma patients | The 3 year mortality of asthma patients | over 3 years | |
Secondary | Genetic markers that predict exacerbation | Genetic markers in blood sample that can help to predict exacerbation and level of control in patients with asthma | over 3 years |
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