A Study to Determine the Clinical Characteristics, Comorbidities, Treatment Status and Exacerbati… (NCT03239431) | Clinical Trial Compass
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A Study to Determine the Clinical Characteristics, Comorbidities, Treatment Status and Exacerbations of Asthma Patients
Hong Kong400 participantsStarted 2017-09-15
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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