Evaluating Customized Antibiotic Duration (CDA) Strategy in Acute Exacerbations of COPD
NCT07708337
Acute Exacerbation of COPD, COPD
Islamabad, Pakistan
View Trial DetailsNCT Number: NCT04318912
This is a multi-center, observational registry study involving secondary and tertiary hospitals across China. The objective is to study the disease burden, disease progression, comorbidities, treatment pattern and real-world cost, effectiveness and safety of different therapy options for COPD patients in Chinese clinical practice in China.
Trial opening soon.
Get Notified20 year and older
All sexes
Observational
COPD is the most common chronic respiratory disease in China and has caused significant economic and humanistic burden. Patient reported outcomes (PRO) have been widely used to assess disease activity and quality of life for COPD patients. Wearable devices enable recording activity data of patients continuously and automatically. The objective of the study is to study the disease burden, disease progression, comorbidities, treatment pattern and real-world cost, effectiveness and safety of different therapy options for COPD patients in Chinese clinical practice in China. This is a multi-center, observational registry study involving secondary and tertiary hospitals across China. 3000-5000 participants are planned to be recruited. Each participant will be followed-up at baseline and every 3 months. Clinical assessment data, laboratory examination data and cost data are captured from electronic medical records (EMR). Patient-reported outcome (PRO) data are collected via smartphone app. Part of patients will receive wearable devices to record digital health technology (DHT) data. As the first ever observational registry focused on COPD stable-period management, this study can provide more information on these following issues. (1) Annual changes in COPD prevalence, treatment pattern and economic burden in China. (2) Assessing the real-world effectiveness and safety of different treatment patterns of COPD via EMR, PRO and DHT. (3) Cost-effectiveness and budget impact to the public healthcare funds of different treatment patterns of COPD.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2 years
Pulmonary Function Test measured by protable spirometer can represent the severity stages of COPD
Time frame: 2 years
Acute exacerbation of symptoms can reflect the disease activity and disease control of COPD.
Time frame: 2 years
Medical expenditure for patients include inpatient cost, outpatient cost and emergency room cost.
Time frame: 2 years
COPD Assessment Test (CAT) is an 8-item, self-reported scale which can represent symptom and health status for COPD patients.
Time frame: 2 years
Euroqol-5 Dimension Questionnaire (EQ-5D) is an 5-item, self-reported scale which can measure health related quality of life.
Time frame: 2 years
Real-time monitoring of oxygen saturation (SpO2) is an objective manifestation of dyspnea.
Contact information is provided by the study sponsor or research team.
Shiyi Gong
CONTACT
Ting Yang
CONTACT
China-Japan Friendship Hospital
Other
An Observational Registry Study for Management of COPD Patients in China
Acronym: ORCHIDS
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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