American journal of respiratory and critical care medicine
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Am. J. Respir. Crit. Care Med. · Jan 2018
Randomized Controlled Trial Multicenter StudyTezacaftor/Ivacaftor in Subjects with Cystic Fibrosis and F508del/F508del-CFTR or F508del/G551D-CFTR.
Tezacaftor (formerly VX-661) is an investigational small molecule that improves processing and trafficking of the cystic fibrosis transmembrane conductance regulator (CFTR) in vitro, and improves CFTR function alone and in combination with ivacaftor. ⋯ These results support continued clinical development of tezacaftor (100 mg every day) in combination with ivacaftor (150 mg every 12 h) in subjects with cystic fibrosis. Clinical trial registered with www.clinicaltrials.gov (NCT01531673).
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Am. J. Respir. Crit. Care Med. · Jan 2018
Multicenter StudyQuantitative Evidence for Revising the Definition of Primary Graft Dysfunction After Lung Transplant.
Primary graft dysfunction (PGD) is a form of acute lung injury that occurs after lung transplantation. The definition of PGD was standardized in 2005. Since that time, clinical practice has evolved, and this definition is increasingly used as a primary endpoint for clinical trials; therefore, validation is warranted. ⋯ The PGD consensus definition can be simplified by combining lower PGD grades. Construct validity of grading was present regardless of transplant procedure type or use of mechanical ventilation. Additional severity categories had minimal impact on mortality or biomarker discrimination.
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Am. J. Respir. Crit. Care Med. · Jan 2018
Multicenter Study Comparative StudyTotal Airway Count on Computed Tomography and the Risk of COPD Progression: Findings from a Population-based Study.
Studies of excised lungs show that significant airway attrition in the "quiet" zone occurs early in chronic obstructive pulmonary disease (COPD). ⋯ TAC may reflect the airway-related disease changes that accumulate in the "quiet" zone in early/mild COPD, indicating that TAC acquired with commercially available software across various CT platforms may be a biomarker to predict accelerated COPD progression.
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Am. J. Respir. Crit. Care Med. · Jan 2018
Randomized Controlled Trial Multicenter Study Comparative StudyEffects of a Telephone- and Web-based Coping Skills Training Program Compared to an Education Program for Survivors of Critical Illness and Their Family Members: A Randomized Clinical Trial.
Many survivors of critical illness and their family members experience significant psychological distress after patient discharge. ⋯ CST did not improve psychological distress symptoms compared with an education program. However, CST improved symptoms of distress at 6 months among patients with high baseline distress, whereas the education program improved distress at 3 months among those ventilated for more than 7 days. Future efforts to address psychological distress among critical illness survivors should target high-risk populations. Clinical trial registered with www.clinicaltrials.gov (NCT01983254).
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Am. J. Respir. Crit. Care Med. · Jan 2018
Randomized Controlled Trial Multicenter StudyA Phase 2 Randomized Controlled Study of Tralokinumab in Subjects with Idiopathic Pulmonary Fibrosis.
IL-13 is a potential therapeutic target for idiopathic pulmonary fibrosis (IPF); preclinical data suggest a role in tissue fibrosis, and expression is increased in subjects with rapidly progressing disease. ⋯ Tralokinumab demonstrated an acceptable safety and tolerability profile but did not achieve key efficacy endpoints. Clinical trial registered with www.clinicaltrials.gov (NCT01629667).