A Study to Determine the Clinical Characteristics, Comorbidities, Treatment Status and Exacerbations of Asthma Patients

NCT03239431 | Unknown

• 1 other identifier: CREC 2017.336
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Keywords

asthma; lung function; forced oscillometry technique; exacerbation

Outcome Measures

Primary Outcomes (2)

• The clinical characteristics of asthma patients

  The clinical characteristics of asthma patients

  over 3 years

• The treatment status of asthma patients

  The treatment status of asthma patients

  over 3 years

Secondary Outcomes (3)

• The 3 year morbidity of asthma patients

  over 3 years

• The 3 year mortality of asthma patients

  over 3 years

• Genetic markers that predict exacerbation

  over 3 years

Study Arms (1)

Asthma group

Patients with asthma

Other: asthmatic exacerbation

Interventions

asthmatic exacerbation OTHER

evaluate the risk factors, frequency and nature of asthma exacerbations

Asthma group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (26)

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Related Links

• CDC information on asthma. Assessed on 28 April 2017

Biospecimen

Retention: SAMPLES WITH DNA

Genetic markers in blood sample that can help to predict exacerbation and level of control in patients with asthma

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Ka Pang Chan, MBChB

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ka Pang Chan, MBChB

CONTACT

852 3505 3396; chankapang@gmail.com

Fanny WS Ko, MBChB, MD

CONTACT

852 3505 3396; fannyko@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Clinical Tutor

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 4, 2017
• Study Start: September 15, 2017
• Primary Completion: December 31, 2021
• Study Completion: January 31, 2022
• Last Updated: January 31, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting 6 months after publication
• Access Criteria: upon individual approach for metaanalysis or related study

Locations

HK (1)