Tokyo, Dec. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059829) titled 'Effect of OPEP Therapy on Symptoms and Airway Clearance in Patients With Chronic Cough and Sputum' on Dec. 10.

Study Type: Observational

Primary Sponsor: Institute - Hirotoshi Yasui, M.D. Department of Respiratory Medicine Toyohashi Municipal Hospital

Condition: Condition - Chronic bronchitis, Bronchiectasis, Non-tuberculous mycobacterial pulmonary disease, Chronic lower airway infection, COPD with chronic sputum symptoms, COPD (chronic obstructive pulmonary disease) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This prospective observational study aims to evaluate the clinical effectiveness of OPEP therapy on symptom improvement in Japanese patients with chronic sputum-producing airway diseases. The primary endpoint is the change in the COPD Assessment Test (CAT) score at 12 weeks. Secondary endpoints include CT mucus plug score, lung function (%FEV1), and sputum culture findings. Factors associated with treatment response will also be explored. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old =18 years) Diagnosed with chronic lower airway disease, including: Chronic bronchitis, Bronchiectasis, Non-tuberculous mycobacterial lung disease, COPD with sputum symptoms Scheduled to start OPEP as part of routine clinical care CAT score >=10 OR CAT 7-9 with sputum item score >=3 Able to provide written informed consent Baseline assessments available within protocol-defined time windows Key exclusion criteria - Acute exacerbation within the past 4 weeks Severe cardiac or cognitive conditions that preclude valid evaluation Contraindications to safe OPEP use (e.g., current pneumothorax) Withdrawal of consent before data lock Inability to ensure clinical stability at the evaluation timepoint Target Size - 70

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 03 Day Anticipated trial start date - 2025 Year 12 Month 10 Day Last follow-up date - 2027 Year 04 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068381

Disclaimer: Curated by HT Syndication.