Mark H. Gotfried
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View article: Plasma and intrapulmonary pharmacokinetics of cefepime and taniborbactam in healthy adult participants
Plasma and intrapulmonary pharmacokinetics of cefepime and taniborbactam in healthy adult participants Open
Cefepime-taniborbactam is being developed for the treatment of serious multidrug-resistant (MDR) Gram-negative bacterial infections. This study determined and compared plasma and epithelial lining fluid (ELF) concentrations of cefepime and…
View article: Intrapulmonary pharmacokinetics of SPR719 following oral administration of SPR720 to healthy volunteers
Intrapulmonary pharmacokinetics of SPR719 following oral administration of SPR720 to healthy volunteers Open
SPR720 is a phosphate ester prodrug that is converted rapidly in vivo to SPR719, the active moiety, which exhibits potent in vitro activity against clinically relevant mycobacterial species including Mycobacterium avium complex (MAC) and M…
View article: Efficacy and safety of insomnia treatment with lemborexant in older adults: analyses from three clinical trials
Efficacy and safety of insomnia treatment with lemborexant in older adults: analyses from three clinical trials Open
View article: Pamrevlumab for Idiopathic Pulmonary Fibrosis
Pamrevlumab for Idiopathic Pulmonary Fibrosis Open
Importance Current treatments for idiopathic pulmonary fibrosis slow the rate of lung function decline, but may be associated with adverse events that affect medication adherence. In phase 2 trials, pamrevlumab (a fully human monoclonal an…
View article: 2144. A Phase 1, Multicenter, Open-Label, Parallel-Group Study to Assess the Safety and Pharmacokinetics (PK) of Oral Epetraborole Tablets in Adult Subjects with Varying Degrees of Renal Function
2144. A Phase 1, Multicenter, Open-Label, Parallel-Group Study to Assess the Safety and Pharmacokinetics (PK) of Oral Epetraborole Tablets in Adult Subjects with Varying Degrees of Renal Function Open
Background Epetraborole (EBO), an orally available bacterial leucyl transfer RNA synthetase inhibitor with potent activity against nontuberculous mycobacteria, is in clinical development for treatment-refractory MAC lung disease. The objec…
View article: Plasma and Intrapulmonary Concentrations of Tebipenem following Oral Administration of Tebipenem Pivoxil Hydrobromide to Healthy Adult Subjects
Plasma and Intrapulmonary Concentrations of Tebipenem following Oral Administration of Tebipenem Pivoxil Hydrobromide to Healthy Adult Subjects Open
Tebipenem pivoxil hydrobromide (TBP-PI-HBr) is an oral carbapenem prodrug being developed for the treatment of serious bacterial infections. The active moiety, tebipenem, has broad-spectrum activity against common Enterobacterales pathogen…
View article: Incidence and duration of common early-onset adverse events in randomized controlled trials of solriamfetol for treatment of excessive daytime sleepiness in obstructive sleep apnea and narcolepsy
Incidence and duration of common early-onset adverse events in randomized controlled trials of solriamfetol for treatment of excessive daytime sleepiness in obstructive sleep apnea and narcolepsy Open
View article: Treatment of Persistent Cough in Subjects with Idiopathic Pulmonary Fibrosis (IPF) with Gefapixant, a P2X3 Antagonist, in a Randomized, Placebo-Controlled Clinical Trial
Treatment of Persistent Cough in Subjects with Idiopathic Pulmonary Fibrosis (IPF) with Gefapixant, a P2X3 Antagonist, in a Randomized, Placebo-Controlled Clinical Trial Open
View article: Reduction in Emergency Department (ED) Visits in Patients with Chronic Obstructive Pulmonary Disease (COPD): Analysis of the IMPACT Trial
Reduction in Emergency Department (ED) Visits in Patients with Chronic Obstructive Pulmonary Disease (COPD): Analysis of the IMPACT Trial Open
View article: Randomized Controlled Trial of Solriamfetol for Excessive Daytime Sleepiness in OSA
Randomized Controlled Trial of Solriamfetol for Excessive Daytime Sleepiness in OSA Open
View article: A randomized, controlled, repeat-dose study of batefenterol/fluticasone furoate compared with placebo in the treatment of COPD
A randomized, controlled, repeat-dose study of batefenterol/fluticasone furoate compared with placebo in the treatment of COPD Open
Background Batefenterol (BAT) is a bi-functional molecule with both muscarinic antagonist and β 2 -adrenoceptor agonist pharmacology. This Phase II, randomized, placebo-controlled, double-blind study evaluated the safety and tolerability o…
View article: Gefapixant, a P2X3 receptor antagonist, for the treatment of refractory or unexplained chronic cough: a randomised, double-blind, controlled, parallel-group, phase 2b trial
Gefapixant, a P2X3 receptor antagonist, for the treatment of refractory or unexplained chronic cough: a randomised, double-blind, controlled, parallel-group, phase 2b trial Open
View article: P004 Solriamfetol for excessive daytime sleepiness in obstructive sleep apnoea: a randomised controlled trial
P004 Solriamfetol for excessive daytime sleepiness in obstructive sleep apnoea: a randomised controlled trial Open
Introduction Obstructive sleep apnoea (OSA) is often associated with persistent excessive daytime sleepiness (EDS) despite sleep apnoea therapy. There are currently no approved treatments in the European Union for the treatment of EDS in t…
View article: 0569 Incidence and Duration of Common Adverse Events in a Solriamfetol (JZP-110) Phase 3 Study for Treatment of Excessive Daytime Sleepiness in Obstructive Sleep Apnea
0569 Incidence and Duration of Common Adverse Events in a Solriamfetol (JZP-110) Phase 3 Study for Treatment of Excessive Daytime Sleepiness in Obstructive Sleep Apnea Open
Solriamfetol, a selective dopamine and norepinephrine reuptake inhibitor, reduced excessive daytime sleepiness (EDS) and increased wakefulness in participants with obstructive sleep apnea (OSA) in a phase 3 study. Post-hoc analysis evaluat…
View article: Solriamfetol for Excessive Sleepiness in Obstructive Sleep Apnea (TONES 3). A Randomized Controlled Trial
Solriamfetol for Excessive Sleepiness in Obstructive Sleep Apnea (TONES 3). A Randomized Controlled Trial Open
Rationale: Primary treatment of obstructive sleep apnea can be accompanied by a persistence of excessive sleepiness despite adherence. Furthermore, effectiveness of sleep apnea treatment is limited by poor adherence. Currently avail…
View article: Plasma and Intrapulmonary Concentrations of ETX2514 and Sulbactam following Intravenous Administration of ETX2514SUL to Healthy Adult Subjects
Plasma and Intrapulmonary Concentrations of ETX2514 and Sulbactam following Intravenous Administration of ETX2514SUL to Healthy Adult Subjects Open
ETX2514 is a novel β-lactamase inhibitor that broadly inhibits Ambler class A, C, and D β-lactamases. ETX2514 combined with sulbactam (SUL) in vitro restores sulbactam activity against Acinetobacter baumannii .
View article: Plasma and Intrapulmonary Concentrations of Cefepime and Zidebactam following Intravenous Administration of WCK 5222 to Healthy Adult Subjects
Plasma and Intrapulmonary Concentrations of Cefepime and Zidebactam following Intravenous Administration of WCK 5222 to Healthy Adult Subjects Open
WCK 5222 is a combination of cefepime and the novel β-lactam enhancer zidebactam being developed for the treatment of serious Gram-negative bacterial infections. The objective of this study was to compare plasma (total), epithelial lining …
View article: An Open-Label, Phase II Study of the Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (PIPF-002)
An Open-Label, Phase II Study of the Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (PIPF-002) Open
View article: Intrapulmonary Pharmacokinetics of Relebactam, a Novel β-Lactamase Inhibitor, Dosed in Combination with Imipenem-Cilastatin in Healthy Subjects
Intrapulmonary Pharmacokinetics of Relebactam, a Novel β-Lactamase Inhibitor, Dosed in Combination with Imipenem-Cilastatin in Healthy Subjects Open
This phase I study assessed the intrapulmonary pharmacokinetic profiles of relebactam (MK-7655), a novel β-lactamase inhibitor, and imipenem. Sixteen healthy subjects received 250 mg relebactam with 500 mg imipenem-cilastatin, given intrav…
View article: Intrapulmonary Pharmacokinetics of Levonadifloxacin following Oral Administration of Alalevonadifloxacin to Healthy Adult Subjects
Intrapulmonary Pharmacokinetics of Levonadifloxacin following Oral Administration of Alalevonadifloxacin to Healthy Adult Subjects Open
Alalevonadifloxacin (WCK 2349) is a novel l -alanine ester prodrug of levonadifloxacin that is being developed as an oral fluoroquinolone antibiotic. The primary objective of this study was to determine and compare plasma, epithelial linin…
View article: Comparison of Omadacycline and Tigecycline Pharmacokinetics in the Plasma, Epithelial Lining Fluid, and Alveolar Cells of Healthy Adult Subjects
Comparison of Omadacycline and Tigecycline Pharmacokinetics in the Plasma, Epithelial Lining Fluid, and Alveolar Cells of Healthy Adult Subjects Open
The steady-state concentrations of omadacycline and tigecycline in the plasma, epithelial lining fluid (ELF), and alveolar cells (AC) of 58 healthy adult subjects were obtained. Subjects were administered either omadacycline at 100 mg intr…
View article: Comparison of Plasma and Intrapulmonary Concentrations of Nafithromycin (WCK 4873) in Healthy Adult Subjects
Comparison of Plasma and Intrapulmonary Concentrations of Nafithromycin (WCK 4873) in Healthy Adult Subjects Open
The nafithromycin concentrations in the plasma, epithelial lining fluid (ELF), and alveolar macrophages (AM) of 37 healthy adult subjects were measured following repeated dosing of oral nafithromycin at 800 mg once daily for 3 days. The va…
View article: Corrigendum to “A multicenter, randomized, double-blind dose-ranging study of glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler compared to the monocomponents and open-label tiotropium dry powder inhaler in patients with moderate-to-severe COPD” [Respir. Med. 120 November 2016 16–24]
Corrigendum to “A multicenter, randomized, double-blind dose-ranging study of glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler compared to the monocomponents and open-label tiotropium dry powder inhaler in patients with moderate-to-severe COPD” [Respir. Med. 120 November 2016 16–24] Open
The authors regret that three inaccuracies were included in this publication in error. In the Method section, the first sentence on page 18 should read, Patients were excluded if they had a current diagnosis of asthma, α1-antitrypsin defic…
View article: 0641 A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, 12-WEEK, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF JZP-110 FOR THE TREATMENT OF EXCESSIVE SLEEPINESS IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA
0641 A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, 12-WEEK, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF JZP-110 FOR THE TREATMENT OF EXCESSIVE SLEEPINESS IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA Open
Patients with obstructive sleep apnea (OSA) may experience excessive sleepiness (ES), which can persist despite primary treatment. JZP-110, a selective dopamine norepinephrine reuptake inhibitor with wake-promoting effects, was evaluated i…
View article: A multicenter, randomized, double-blind dose-ranging study of glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler compared to the monocomponents and open-label tiotropium dry powder inhaler in patients with moderate-to-severe COPD
A multicenter, randomized, double-blind dose-ranging study of glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler compared to the monocomponents and open-label tiotropium dry powder inhaler in patients with moderate-to-severe COPD Open
View article: Meropenem-RPX7009 Concentrations in Plasma, Epithelial Lining Fluid, and Alveolar Macrophages of Healthy Adult Subjects
Meropenem-RPX7009 Concentrations in Plasma, Epithelial Lining Fluid, and Alveolar Macrophages of Healthy Adult Subjects Open
The steady-state concentrations of meropenem and the β-lactamase inhibitor RPX7009 in plasma, epithelial lining fluid (ELF), and alveolar macrophage (AM) concentrations were obtained in 25 healthy, nonsmoking adult subjects. Subjects recei…
View article: <i>ERJ</i>Podcast September 2015: Updating the GINA guidelines for asthma control
<i>ERJ</i>Podcast September 2015: Updating the GINA guidelines for asthma control Open
View article: A randomised trial of lung sealant<i>versus</i>medical therapy for advanced emphysema
A randomised trial of lung sealant<i>versus</i>medical therapy for advanced emphysema Open
Uncontrolled pilot studies demonstrated promising results of endoscopic lung volume reduction using emphysematous lung sealant (ELS) in patients with advanced, upper lobe predominant emphysema. We aimed to evaluate the safety and efficacy …