Kun Ming Shi

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Non-cystic fibrosis bronchiectasis (NCFBE) is a chronic lung condition marked by long-term cough with mucus and repeated lung infections, caused by permanent widening of the airways. This condition is becoming more common worldwide, including in China, where patients show unique clinical features compared to Western populations. The study aims to explore the biological processes and molecular types behind these clinical differences in Chinese NCFBE patients using advanced biomarker and multi-omics analyses. The study is a multi-center, longitudinal, observational research involving patients diagnosed with NCFBE by chest high-resolution CT (HRCT) and healthy controls. Participants will have a baseline visit, a 6-month follow-up (either in person or by phone), and a 12-month visit, with additional unscheduled visits if respiratory flare-ups occur. Healthy controls will only participate at baseline and may have an optional bronchoscopy visit. The study focuses on collecting clinical data and biological samples to assess disease pathways and molecular markers. Participants will undergo lung function tests, biomarker assessments, and various clinical evaluations at scheduled visits over one year. Researchers will measure lung function, airway inflammation, imaging results, cell counts, gene expression, and other health outcomes to understand disease patterns. Safety and health status will be monitored throughout, including during any exacerbations. The total study duration for each participant is 12 months, with careful tracking of clinical and molecular changes during this period.

This research focuses on adults with bronchiectasis who are affected by Pseudomonas aeruginosa (PA) infections. The ERASE II study follows up on an earlier trial that tested the safety and effectiveness of Tobramycin Inhalation Solution to eradicate PA. The goal is to see how successfully removing PA impacts the long-term health outcomes of these patients, including quality of life and lung function. The study includes an initial 9-month period from the original ERASE trial, followed by an additional 27 months of observation, totaling 36 months. During this extended follow-up, no new interventions are given; instead, patients are monitored to track their health status, including any recurrence of PA infection and related complications. Participants will have their lung function, quality of life, number of lung flare-ups, hospital stays, and treatment costs regularly assessed. Researchers will also monitor sputum samples at multiple points up to 15 months to check for PA eradication. This comprehensive monitoring aims to understand the lasting effects of PA removal on bronchiectasis progression and patient well-being over three years.