Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060502) titled 'Clinical Significance of ROSE-defined Bronchiectasis in Japanese Patients with Chronic Obstructive Pulmonary Disease: A Single-centre Retrospective Cohort Study' on April 1.
Study Type:
Observational
Primary Sponsor:
Institute - National Hospital Organization, Osaka Toneyama Medical Center
Condition:
Condition - Chronic Obstructive Pulmonary Disease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the utility of the ROSE criteria in Japanese patients with COPD.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - (1) chronic respiratory symptoms consistent with COPD (such as dyspnoea, cough, sputum production, or a history of exacerbations); (2) a relevant exposure history, including cigarette smoking; and (3) confirmation of persistent airflow limitation, defined as a post-bronchodilator forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) ratio of <0.7 on spirometry.
Key exclusion criteria - (1) age <18 years, (2) concurrent interstitial lung disease to rule out traction BE, and (3) visits primarily for lung cancer treatment to avoid confounding effects on prognosis.
Target Size - 300
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2016 Year 04 Month 01 Day
Date of IRB - 2024 Year 03 Month 31 Day
Anticipated trial start date - 2016 Year 04 Month 01 Day
Last follow-up date - 2025 Year 07 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069217
Disclaimer: Curated by HT Syndication.