Clinical trial NCT03272932: Clinical Characteristics of Asthma and COPD Overlap for Patients With Asthma and COPD in Hong Kong
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COPD
Asthma
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with asthma or COPD

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

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

Primary outcomes:
measure: Percentage of prevalence of Asthma COPD overlap among the asthma and COPD subjects.
timeFrame: 3 years
Secondary outcomes:
measure: Percentage of patient with treatment that is different from the guidelines recommendation
timeFrame: 3 years
measure: The percentages of patients on various medications (e.g. inhaled steroid, LABA, LAMA)
timeFrame: 3 years
measure: The pecentages of patients receiving different symptoms control assessments (e.g. use of Asthma control test, use of COPD assessment test)
timeFrame: 3 years
measure: Percentages of subjects with morbidity (e.g. congestive heart failure)
timeFrame: 3 years
measure: Percentages of subjects with mortality
timeFrame: 3 years
measure: Percentages of patients with various Genetic markers
timeFrame: 3 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Fanny Ko, MD
role: PRINCIPAL_INVESTIGATOR
References: