KOrea COpd Subgroup Registry and Subtype Research (KOCOSS)
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|ClinicalTrials.gov Identifier: NCT02800499|
Recruitment Status : Recruiting
First Posted : June 15, 2016
Last Update Posted : March 7, 2018
|Condition or disease|
This study is a multicentered, observational study of the patients with COPD who were enrolled in 45 tertiary and university-affiliated hospitals from December 2012 to now.
The initial evaluation for all patients includes pulmonary function tests (PFT), 6-min walk distance (6MWD), COPD Assessment Test (CAT), modified Medical Research Council (mMRC) dyspnea scale, and the COPD-specific version of St. George's Respiratory Questionnaire (SGRQ-C), exacerbations in the previous 12 months, smoking status, patient-reported education level, medications and comorbidities.
Pulmonary function tests (PFTs) are performed every 6 months and CAT, mMRC and SGRQ-C are evaluated every 6 months and 6 min walt test is performed every years during the whole period of study.
All of the data were reported using case-report forms (CRFs) which are completed by physicians or trained nurses, and the patients are to be evaluated at regular 6-month intervals after the initial examination.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||2000 participants|
|Target Follow-Up Duration:||10 Years|
|Official Title:||Domestic COPD Patients Registry Business and COPD Phenotype Research Based by Registry Data - Multi-centered Trial|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||January 2022|
The KOrea COpd Subgroup Study team (KOCOSS) cohort is an ongoing, longitudinal, prospective, non-interventional observational study within the Korean COPD patients
- Number of acute exacerbation [ Time Frame: 5 years ]Number of events
- Pulmonary function tests [ Time Frame: 5 years ]COPD severity will be assessed based on post-bronchodilator Forced expiratory volume in one second(FEV) and FEV1/FVC(Forced vital capacity). FEV1 to forced vital capacity (FVC) :Mild - FEV1/FVC<0.7, FEV1 ≥80% normal Moderate - FEV1/FVC<0.7, FEV1 50-79% normal; Severe - FEV1/FVC<0.70, FEV1 30-49% normal; Very Severe - FEV1/FVC<0.70, FEV1 <30% predicted. We will measure spirometry at screening and every 6 months.
- Modified Medical Research Council [mMRC] dyspnea scale [ Time Frame: 5 years ]mMRC dyspnea scale is five-point scale with higher scores indicating more severe dyspnea. We will assess mMRC at screening and every 6 months.
- COPD Assessment Test (CAT) [ Time Frame: 5 years ]The CAT score was also used for evaluation of dyspnea. It consists of 8 items, each scored from 0 to 5, with higher scores indicating a more severe symptom.We will measure CAT at screening and every 6 months.
- 6-min walk distance (6MWD) [ Time Frame: 5 years ]The 6MWD has been used as a simple tool to assess overall exercise tolerance in COPD patients. We will measure 6 min walk distance by ATS guideline at screening and every 6 months during the follow-up period
- the COPD-specific version of St. George's Respiratory Questionnaire (SGRQ-C) [ Time Frame: 5 years ]to assess the health status from the patient's perspective .The SGRQ-C is a 14-item questionnaire that can be summarized as a total score, as well as by three component scores for symptoms, activities, and impacts. We will assess SGRQ at screening and every 6 months.
- Percentage of Participants with smoking history [ Time Frame: 5 years ]we will assess smoking history at screening and every 6 months
- Percentage of Participants with Other Relevant Diseases [ Time Frame: 5 years ]We will examine the relevant disease which is defined as respiratory diseases, cardiovascular diseases (ischaemic heart disease, heart failure, hypertension), and other diseases (osteoporosis, GERD(gastroesophageal reflux disease), hyperlipidemia, bronchiectasis, emphysema).
- COPD Treatment [ Time Frame: Through study completion, average 5 years ]COPD treatments are defined as inhaled therapies, oral therapies and other therapies administered during the enrollment and influenza vaccination and smoking cessation therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800499
|Contact: Kwang-Ha NA Yoo, Doctoremail@example.com|
|Contact: Hyun- Ae NA Kim, Bachelorfirstname.lastname@example.org|
|Principal Investigator:||Ki-Seok NA Jung, Doctor||Hallym University Medical Center|