Chest
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The US Food and Drug Administration convened a workshop to discuss clinical trial design challenges and considerations related to the treatment of nontuberculous mycobacterial pulmonary disease, to include topics such as clinical trial end points, duration, and populations. The clinicians participating in the meeting provide here their interpretation of the discussion, which included US Food and Drug Administration and industry representatives. ⋯ Accordingly, trial designs for new therapeutic agents should incorporate both microbiologic and clinical outcome measures and select appropriate study candidates with capacity for measurable change of such outcome measures. The need for shorter study designs, early primary end points, and placebo control arms was highlighted during the workshop.
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Review Case Reports
How I Do It: Approach to Eosinophilia Presenting with Pulmonary Symptoms.
Eosinophilia with pulmonary involvement is characterized by the presence of peripheral blood eosinophilia, typically ≥500 cells/mm3, by pulmonary symptoms and physical examination findings that are nonspecific, and by radiographic evidence of pulmonary disease and is further supported by histopathologic evidence of tissue eosinophilia in a lung or pleura biopsy specimen and/or increased eosinophils in BAL fluid, usually >10%. Considering that there are a variety of underlying causes of eosinophilia with pulmonary manifestations and overlapping clinical, laboratory, and radiologic features, it is essential to approach the evaluation of eosinophilia with pulmonary findings systematically. ⋯ Overall, optimal management of eosinophilic lung disease presentations are directed at the underlying cause when identifiable, and the urgency of treatment may be guided by the presence of severe end-organ involvement or life-threatening complications. When an underlying cause is not easily attributable, management of eosinophilia with pulmonary involvement largely relies on eosinophil-directed interventions, for which biologic therapies are increasingly being used.
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Clofazimine has been regarded as a promising agent for the treatment of nontuberculous mycobacteria pulmonary disease (NTM-PD). However, its overall effectiveness in vitro and in the clinic remains unknown. ⋯ The MICs of clofazimine varied widely in clinical isolates from patients with NTM-PD. Negative conversion of sputum culture with clofazimine use was associated with a lower MIC value. Clofazimine use could be considered in patients with NTM-PD when the MIC value is ≤ 0.25 mg/L.
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A right heart catheterization with measurements of pulmonary artery wedge pressure (PAWP) may be necessary for the diagnosis of left heart failure as a cause of pulmonary hypertension or unexplained dyspnea. Diagnostic cutoff values are a PAWP of ≥ 15 mm Hg at rest or a PAWP of ≥ 25 mm Hg during exercise. However, accurate measurement of PAWP can be challenging and heart failure may be occult. ⋯ The procedure is simple and does not take much catheterization laboratory time. Combining echocardiography with invasive measurements may increase the diagnostic accuracy of diastolic dysfunction. Cardiac output after a fluid challenge may be of prognostic relevance.
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Multicenter Study
Robotic Bronchoscopy for Peripheral Pulmonary Lesions: A Multicenter Pilot and Feasibility Study (BENEFIT).
The diagnosis of peripheral pulmonary lesions (PPL) continues to present clinical challenges. Despite extensive experience with guided bronchoscopy, the diagnostic yield has not improved significantly. Robotic-assisted bronchoscopic platforms have been developed potentially to improve the diagnostic yield for PPL. Presently, limited data exist that evaluate the performance of robotic systems in live human subjects. ⋯ ClinicalTrials.gov; No.: NCT03727425; URL: www.clinicaltrials.gov.