Clinical Characteristics of Asthma and COPD Overlap for Patients With Asthma and COPD in Hong Kong

March 17, 2026 updated by: Fanny W.S. Ko, Chinese University of Hong Kong

A Cross-sectional Study to Assess the Proportion and Clinical Characteristics of Asthma and COPD Overlap for Patients With Asthma and COPD in Hong Kong.

This study is to assess the prevalence of Asthma COPD Overlap in subjects with diagnosed asthma and chronic obstructive pulmonary disease (COPD). The subsequent morbidity and mortality of subjects will be followed up for 3 years.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Rationale:

Around 15 to 20% of COPD patients have features of asthma. These patients have more frequent and more severe exacerbations, and higher medical utilization. The Global Initiative for Asthma (GINA) and Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines have given joint recommendations on the identification, diagnosis and treatment of these patients having Asthma-COPD Overlap (ACO). These are at present expert opinions and further studies are needed to establish the optimal definitions and treatment options. The recommendations proposed by the guidelines have been adapted for use in the Asia area countries. Nonetheless, the application to clinical practice has not been well established and there are no prevalence data available on the COPD with asthma symptom population or asthma with COPD symptoms population based on the recommended features for identification. This is the current data gap in Asia.

Primary objective:

To determine the proportion and clinical characteristics of patients with ACO as defined by the joint GINA and GOLD recommendation amongst diagnosed COPD and asthma patients seen at the out-patient clinics

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1600

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Subjects with asthma or COPD

Description

Inclusion Criteria:

Subjects must fulfil all of the following criteria:

  • All patients with confirmed diagnosis of COPD (post-bronchodilator FEV1/FVC<0.7 based on the medical records) 1 or 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 400 mL following bronchodilator or bronchial hyperresponsiveness on bronchial provocation testing, when stable) 6
  • Aged >40 years old
  • Signed written informed consent to participate in the study

Exclusion Criteria:

  • Patients currently with acute exacerbation of COPD by GOLD definition (any worsening of a patient's respiratory symptoms that is beyond normal day-to-day variations and requires a change in medication) 1 or acute exacerbation of asthma by GINA guideline. 6
  • Patients with respiratory diseases that can show similar symptoms to chronic airway diseases such as bronchiectasis, tuberculosis (TB)-destroyed lung parenchyma, endobronchial TB, and lung cancer, or those who have history of these diseases based on physician's judgment
  • Patients currently diagnosed with pneumonia and acute bronchitis
  • 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of prevalence of Asthma COPD overlap among the asthma and COPD subjects.
Time Frame: 3 years
To determine the proportion and clinical characteristics of patients with ACO as defined by the joint GINA and GOLD recommendation amongst diagnosed COPD and asthma patients seen at the out-patient clinics. (Assessment: % of subjects with ACO among patients with asthma and COPD respectively)
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of patient with treatment that is different from the guidelines recommendation
Time Frame: 3 years
To evaluate the gap between guideline recommendations and real-world clinical practice in identifying COPD patients with asthma and asthma patients with COPD
3 years
The percentages of patients on various medications (e.g. inhaled steroid, LABA, LAMA)
Time Frame: 3 years
To review the medications given to COPD patients with asthma and asthma patients with COPD compared to guideline recommendations
3 years
The pecentages of patients receiving different symptoms control assessments (e.g. use of Asthma control test, use of COPD assessment test)
Time Frame: 3 years
To review the current practices of symptom control assessment
3 years
Percentages of subjects with morbidity (e.g. congestive heart failure)
Time Frame: 3 years
To assess the 3 year morbidity of ACO patient compared to COPD and asthma patients.
3 years
Percentages of subjects with mortality
Time Frame: 3 years
To assess the 3 year mortality of ACO patient compared to COPD and asthma
3 years
Percentages of patients with various Genetic markers
Time Frame: 3 years
Genetic markers got differentiating ACO patients from patients with COPD or asthma
3 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fanny Ko, MD, Chinese University of Hong Kong

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CCUHK_Resp_ACOS_v1(5Apr2017)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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