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Safety, Tolerability, and Pharmacokinetics of SC1011 (Sufenidone), a Novel Antifibrotic Small Molecule, in Phase 1 Studies in Healthy Subjects.
Clin Transl Sci
March 2025
The First Affiliated Hospital of Guangzhou, University of Chinese Medicine, Guangzhou, Guangdong, China.
SC1011 (sufenidone) is a novel pyridone derivative with therapeutic potential for idiopathic pulmonary fibrosis (IPF). Two Phase 1 studies evaluated the safety and pharmacokinetics of single (SAD) and multiple ascending doses (MAD) of SC1011 immediate-release (IR) and modified-release (MR) oral formulations in healthy adult subjects. In Phase 1a, subjects were randomized to receive oral SC1011 IR or placebo in SAD (50 mg-300 mg) or MAD (100 mg and 200 mg) twice daily for 7 days.
View Article and Find Full Text PDFLack of diversity in antifibrotic trials for pulmonary fibrosis: a systematic review.
Eur Respir Rev
January 2025
Respiratory Research @ Alfred, School of Translational Medicine Monash University, Melbourne, Australia
Introduction: Social determinants of health (SDH), including age, sex, ethnicity, socioeconomic status and rurality, influence health outcomes. Clinical trials investigating antifibrotic agents for people with idiopathic pulmonary fibrosis (IPF) have been conducted in predominantly White and male populations; it is unclear whether other SDH have been considered. This study aimed to investigate active consideration and reporting of SDH in clinical trials of antifibrotic agents for people with IPF.
View Article and Find Full Text PDFHuman respiratory airway progenitors derived from pluripotent cells generate alveolar epithelial cells and model pulmonary fibrosis.
Nat Biotechnol
February 2025
Columbia Center for Stem Cell Therapies/Columbia Center for Human Development, Department of Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA.
Human lungs contain unique cell populations in distal respiratory airways or terminal and respiratory bronchioles (RA/TRBs) that accumulate in persons with lung injury and idiopathic pulmonary fibrosis (IPF), a lethal lung disease. As these populations are absent in rodents, deeper understanding requires a human in vitro model. Here we convert human pluripotent stem cells (hPS cells) into expandable spheres, called induced respiratory airway progenitors (iRAPs), consisting of ~98% RA/TRB-associated cell types.
View Article and Find Full Text PDFPathophysiology of small airways in idiopathic pulmonary fibrosis (IPF): the silent zone.
Expert Rev Respir Med
February 2025
Respiratory Translational Research Group, Department of Laboratory Medicine, School of Health Sciences, University of Tasmania, Launceston, Tasmania, Australia.
Introduction: Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive lung disease characterized by distorted alveolar structure and reduced lung compliance, and impaired ventilation-perfusion. Small airway disease (SAD) is often termed a 'quietzone' due to its asymptomatic nature. Around 30-40% of IPF patients exhibit SAD, which is associated with worse prognosis, higher fibrosis and emphysema scores, and elevated mortality risk.
View Article and Find Full Text PDFVasoreactive testing prevalence and characteristics in patients with idiopathic pulmonary arterial hypertension.
Ann Thorac Med
January 2025
Department of Noncoronary Disease, Almazov National Medical Research Center, Saint-Petersburg, Russia.
Introduction: The choice of treatment strategy in patients with idiopathic pulmonary arterial hypertension (IPAH)/HPAH/DPAH (Hereditary pulmonary arterial hypertension/ Drug-induced pulmonary arterial hypertension) II-III functional class (FC) (WHO) based on an acute vasoreactive testing result (VRT). Positive VRT (VRT+) is an indication for calcium channel blockers therapy. Long-term vasoresponders demonstrate sustained low-risk status and the highest survival among all PH subtypes.
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