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

January 29, 2019 updated by: Ka Pang Chan, Chinese University of Hong Kong

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Asthma group
Patients with asthma
Other: asthmatic exacerbation
evaluate the risk factors, frequency and nature of asthma exacerbations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The clinical characteristics of asthma patients
Time Frame: over 3 years
The clinical characteristics of asthma patients
over 3 years
The treatment status of asthma patients
Time Frame: over 3 years
The treatment status of asthma patients
over 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The 3 year morbidity of asthma patients
Time Frame: over 3 years
The 3 year morbidity of asthma patients
over 3 years
The 3 year mortality of asthma patients
Time Frame: over 3 years
The 3 year mortality of asthma patients
over 3 years
Genetic markers that predict exacerbation
Time Frame: over 3 years
Genetic markers in blood sample that can help to predict exacerbation and level of control in patients with asthma
over 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 15, 2017

Primary Completion (ANTICIPATED)

December 31, 2021

Study Completion (ANTICIPATED)

January 31, 2022

Study Registration Dates

First Submitted

July 27, 2017

First Submitted That Met QC Criteria

August 1, 2017

First Posted (ACTUAL)

August 4, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREC 2017.336

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

Starting 6 months after publication

IPD Sharing Access Criteria

upon individual approach for metaanalysis or related study

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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