American journal of respiratory and critical care medicine
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Am. J. Respir. Crit. Care Med. · Feb 2025
Randomized Controlled TrialEffect of Triple Therapy on Cardiovascular and Severe Cardiopulmonary Events in COPD: A Post-hoc Analysis of a Randomized, Double-Blind, Phase 3 Clinical Trial (ETHOS).
Rationale: Chronic obstructive pulmonary disease (COPD) is associated with an increased risk of cardiovascular and cardiopulmonary events. In the phase III, 52-week ETHOS trial (NCT02465567), triple therapy with budesonide/glycopyrrolate/formoterol fumarate (BGF) reduced rates of moderate/severe exacerbations and all-cause mortality compared with dual therapy with glycopyrrolate/formoterol fumarate (GFF) or budesonide/formoterol fumarate (BFF). However, the effect of BGF on cardiovascular events versus GFF remains unevaluated. ⋯ Time to first severe COPD exacerbation was a prespecified endpoint; post hoc cardiovascular and severe cardiopulmonary endpoints included time to first major adverse cardiac event, time to first cardiovascular adverse event (AE) of special interest, time to first cardiac AE, and time to the composite endpoint of first severe cardiopulmonary event. Measurements and Main Results: BGF 320 reduced the rate of first occurrence (hazard ratio [95% confidence interval]) of cardiovascular and severe cardiopulmonary events versus GFF, including for time to first cardiovascular adverse event of special interest (0.63 [0.48, 0.82]), cardiac AE (0.60 [0.48, 0.76]), and severe cardiopulmonary event (0.80 [0.67, 0.95]). Conclusions: BGF had a benefit on cardiovascular endpoints and severe cardiopulmonary events versus GFF in patients with moderate to very severe COPD.
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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).