COPDNCT03272932
Clinical Characteristics of Asthma and COPD Overlap for Patients With Asthma and COPD in Hong Kong
An observational study of COPD and Asthma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 1,600 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Sep 2017to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with asthma or COPD
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- No intervention
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of prevalence of Asthma COPD overlap among the asthma and COPD subjects.
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)
Measured: 3 years
Secondary outcomes (6)
Percentage of patient with treatment that is different from the guidelines recommendation
To evaluate the gap between guideline recommendations and real-world clinical practice in identifying COPD patients with asthma and asthma patients with COPD
Measured: 3 years
The percentages of patients on various medications (e.g. inhaled steroid, LABA, LAMA)
To review the medications given to COPD patients with asthma and asthma patients with COPD compared to guideline recommendations
Measured: 3 years
The pecentages of patients receiving different symptoms control assessments (e.g. use of Asthma control test, use of COPD assessment test)
To review the current practices of symptom control assessment
Measured: 3 years
Percentages of subjects with morbidity (e.g. congestive heart failure)
To assess the 3 year morbidity of ACO patient compared to COPD and asthma patients.
Measured: 3 years
Percentages of subjects with mortality
To assess the 3 year mortality of ACO patient compared to COPD and asthma
Measured: 3 years
Percentages of patients with various Genetic markers
Genetic markers got differentiating ACO patients from patients with COPD or asthma
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start15 Sep 2017
- Primary completion30 Dec 2025
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fanny W.S. Ko, Chinese University of Hong Kong
- Investigators
- Fanny Ko, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272932
- Sponsor's protocol ID
- CCUHK_Resp_ACOS_v1(5Apr2017)
- Status last verified
- Mar 2026
- First submitted
- 1 Sep 2017
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ko FWS, Chan KKP, Ng TCC, Lo RLP, Ngai JCL, To KW, Yip WH, Ng JKC, Chan C, Lau CHY, Hui DSC. A 3-year prospective study to assess clinical characteristics and risk factors for exacerbations in patients with asthma-COPD overlap based on the GINA guideline compared with patients with asthma and COPD. Respir Res. 2026 Mar 29;27(1):202. doi: 10.1186/s12931-026-03643-0.
PubMed 41904521
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03272932
- Acronym / sponsor ID
- CCUHK_Resp_ACOS_v1(5Apr2017)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 6 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with asthma or COPD
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
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)
6 secondary outcomes
Percentage of patient with treatment that is different from the guidelines recommendation
Time frame: 3 years
The percentages of patients on various medications (e.g. inhaled steroid, LABA, LAMA)
Time frame: 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
Percentages of subjects with morbidity (e.g. congestive heart failure)
Time frame: 3 years
Percentages of subjects with mortality
Time frame: 3 years
Percentages of patients with various Genetic markers
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Derived from this study: PubMed 41904521Ko FWS, Chan KKP, Ng TCC, Lo RLP, Ngai JCL, To KW, Yip WH, Ng JKC, Chan C, Lau CHY, Hui DSC. A 3-year prospective study to assess clinical characteristics and risk factors for exacerbations in patients with asthma-COPD overlap based on the GINA guideline compared with patients with asthma and COPD. Respir Res. 2026 Mar 29;27(1):202. doi: 10.1186/s12931-026-03643-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fanny Ko, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Asthma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of prevalence of Asthma COPD overlap among the asthma and COPD subjects. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03272932, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.