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

Asthma Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03272932
• Other study ID #: CCUHK_Resp_ACOS_v1(5Apr2017)
• Status: Recruiting
• Start date: September 15, 2017
• Est. completion date: December 30, 2023

Study information

• Verified date: February 2023
• Source: Chinese University of Hong Kong
• Contact: April Ip, BSc
• Phone: 852 35053396
• Email: april_ip[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• COPD

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	3 years
Secondary	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	3 years
Secondary	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	3 years
Secondary	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	3 years
Secondary	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.	3 years
Secondary	Percentages of subjects with mortality	To assess the 3 year mortality of ACO patient compared to COPD and asthma	3 years
Secondary	Percentages of patients with various Genetic markers	Genetic markers got differentiating ACO patients from patients with COPD or asthma	3 years