American journal of respiratory and critical care medicine
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Am. J. Respir. Crit. Care Med. · Feb 2025
Randomized Controlled Trial Multicenter StudyEfficacy and Safety of Admilparant, an LPA1 Antagonist in Pulmonary Fibrosis: A Phase 2 Randomized Clinical Trial.
Rationale: Idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) have high morbidity and mortality; thus, novel treatments are needed. Objectives: Assess efficacy and safety of admilparant (BMS-986278), an oral lysophosphatidic acid receptor 1 antagonist, in patients with IPF and PPF. Methods: This phase 2, randomized, double-blind, placebo-controlled trial included parallel cohorts of patients with IPF (n = 278 randomized, n = 276 treated) or PPF (n = 125 randomized, n = 123 treated) who received 30 mg of admilparant, 60 mg of admilparant, or placebo (1:1:1) twice daily for 26 weeks. ⋯ Treatment discontinuations because of adverse events were similar across IPF arms and lower with admilparant (2.5% [30 mg]; 0% [60 mg]) versus placebo (17.1%) for PPF. Conclusions: In this first phase 2 study to evaluate antifibrotic treatment in parallel IPF and PPF cohorts, 60-mg admilparant slowed lung function decline and was safe and well tolerated, supporting further evaluation in phase 3 trials. Clinical trial registered with clinicaltrials.gov identifier (NCT04308681).
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Am. J. Respir. Crit. Care Med. · Feb 2025
Randomized Controlled Trial Multicenter StudyPeer-Driven Intervention for Care Coordination and Adherence Promotion for Obstructive Sleep Apnea: A Randomized, Parallel-Group Clinical Trial.
Rationale: Obstructive sleep apnea (OSA) is a common condition that is usually treated by continuous positive airway pressure (CPAP) therapy, but poor adherence is common and is associated with worse patient outcomes and experiences. Patient satisfaction is increasingly adopted as a quality indicator by healthcare systems. Objectives: We tested the hypothesis that peer-driven intervention effected through an interactive voice response (IVR) system leads to better patient satisfaction (primary outcome), care coordination, and CPAP adherence than active control. ⋯ Conclusions: Patient satisfaction with care delivery, CPAP adherence, and care coordination were improved by peer-driven intervention through an IVR system. New payor policies compensating peer support may enable implementation of this approach. Clinical trial registered with www.clinicaltrials.gov (NCT02056002).
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Am. J. Respir. Crit. Care Med. · Feb 2025
Randomized Controlled Trial Multicenter StudyHumidified Noninvasive Ventilation versus High-Flow Therapy to Prevent Reintubation in Patients with Obesity: A Randomized Clinical Trial.
Rationale: The optimal strategy to prevent reintubation in patients with obesity remains uncertain. Objectives: We aimed to determine whether noninvasive ventilation (NIV) with active humidification is superior to a high-flow nasal cannula (HFNC) in preventing reintubation in patients with obesity at intermediate risk. Methods: We conducted a randomized controlled trial in two ICUs in Spain (June 2020-June 2021). ⋯ Conclusions: Among adult critically ill patients with obesity at intermediate risk for extubation failure, the rate of reintubation was not significantly lower with NIV than with HFNC. Nevertheless, there is a risk for underpowered results. Clinical trial registered with www.clinicaltrials.gov (NCT04125342).
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Am. J. Respir. Crit. Care Med. · Feb 2025
Practice GuidelineInterventional Strategies for Children with Progressive Pulmonary Hypertension Despite Optimal Therapy. An Official American Thoracic Society Clinical Practice Guideline.
Background: Pulmonary hypertension in children is progressive with wide variability in prognosis. This document provides an evidence-based clinical practice guideline for the management of children with progressive pulmonary hypertension despite optimal therapy. Methods: A multidisciplinary panel identified pertinent questions regarding the management of children with pulmonary hypertension that has progressed despite optimal therapy, conducted systematic reviews of the relevant literature, and applied the Grading of Recommendations, Assessment, Development and Evaluation approach to develop clinical recommendations. ⋯ Conclusions: Although there is a growing population of children with pulmonary hypertension, there is a striking lack of empirical evidence regarding management of those whose disease has progressed despite optimal pharmacotherapy. The panel formulated and provided the rationale for clinical recommendations for or against interventional strategies on the basis of this limited empirical evidence, coupled with expert opinion, to aid clinicians in the management of these complex pediatric patients. In addition, we identified important areas for future research.
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Am. J. Respir. Crit. Care Med. · Feb 2025
Serum Immunoglobulin G Levels Are Associated with Risk for Exacerbations: An Analysis of SPIROMICS.
Rationale: Serum IgG deficiency is associated with morbidity in chronic obstructive pulmonary disease (COPD), but it is unclear whether concentrations in the lower end of the normal range still confer risk. Objectives: To determine if levels above traditional cutoffs for serum IgG deficiency are associated with exacerbations among current and former smokers with or at risk for COPD. Methods: Former and current smokers in SPIROMICS (the Subpopulations and Intermediate Outcome Measures of COPD study) (n = 1,497) were studied: 1,026 with COPD and 471 at risk for COPD. ⋯ Conclusions: Lower serum IgG is prospectively associated with exacerbations in individuals with or at risk for COPD. Among subclasses, lower IgG1 and IgG2 are prospectively associated with severe exacerbations. The optimal IgG cutoff was substantially higher than traditional cutoffs for deficiency, suggesting that subtle impairment of humoral immunity may be associated with exacerbations.