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

NCT ID: NCT03272932

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-15
• Study Completion Date: 2025-12-30

Brief 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.

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

Conditions

COPD; Asthma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

No intervention

No intervention

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Fanny W.S. Ko

Honorary Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fanny Ko, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Prince of Wales Hospital

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

April Ip, BSc

Role: CONTACT

april_ip@cuhk.edu.hk

852 35053396

Fanny Ko, MD

Role: CONTACT

fannyko@cuhk.edu.hk

852 35053133

Facility Contacts

Fanny Ko, MD

Role: primary

fannyko@cuhk.edu.hk

852 35053133

Other Identifiers

CCUHK_Resp_ACOS_v1(5Apr2017)

Identifier Type: -

Identifier Source: org_study_id