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OpenTrials
Active, Not Recruiting

NCT Number: NCT03272932

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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. 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

  4. 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.

  5. Percentages of subjects with mortality

    Time frame: 3 years

    To assess the 3 year mortality of ACO patient compared to COPD and asthma

  6. Percentages of patients with various Genetic markers

    Time frame: 3 years

    Genetic markers got differentiating ACO patients from patients with COPD or asthma

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2025
Study completion
2026
First posted
Sep 6, 2017
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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