Browsing by Subject "Aerosol"

Now showing 1 - 4 of 4
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    Inhaled mRNA therapy for treatment of cystic fibrosis: Interim results of a randomized, double-blind, placebo-controlled phase 1/2 clinical study
    (Elsevier, 2023) Rowe, S. M.; Zuckerman, J. B.; Dorgan, D.; Lascano, J.; McCoy, K.; Jain, M.; Schechter, M. S.; Lommatzsch, S.; Indihar, V.; Lechtzin, N.; McBennett, K.; Callison, C.; Brown, C.; Liou, T. G.; MacDonald, K. D.; Nasr, S. Z.; Bodie, S.; Vaughn, M.; Meltzer, E. B.; Barbier, A. J.; Medicine, School of Medicine
    Background: MRT5005, a codon-optimized CFTR mRNA, delivered by aerosol in lipid nanoparticles, was designed as a genotype-agnostic treatment for CF lung disease. Methods: This was a randomized, double-blind, placebo-controlled Phase 1/2 study performed in the US. Adults with 2 severe class I and/or II CFTR mutations and baseline ppFEV1 values between 50 and 90% were randomized 3:1 (MRT5005: placebo). Six dose levels of MRT5005 (4, 8, 12, 16, 20, and 24 mg) or placebo (0.9% Sodium Chloride) were administered by nebulization. The single ascending dose cohort was treated over a range from 8 to 24 mg; the multiple ascending dose cohort received five weekly doses (range 8-20 mg); and the daily dosing cohort received five daily doses (4 mg). Results: A total of 42 subjects were assigned to MRT5005 [31] or placebo [11]. A total of 14 febrile reactions were observed in 10 MRT5005-treated participants, which were mild [3] or moderate [11] in severity; two subjects discontinued related to these events. Additionally, two MRT5005-treated patients experienced hypersensitivity reactions, which were managed conservatively. The most common treatment emergent adverse events were cough and headache. No consistent effects on FEV1 were noted. Conclusions: MRT5005 was generally safe and well tolerated through 28 days of follow-up after the last dose, though febrile and hypersensitivity reactions were noted. The majority of these reactions resolved within 1-2 days with supportive care allowing continued treatment with MRT5005 and careful monitoring. In this small first-in-human study, FEV1 remained stable after treatment, but no beneficial effects on FEV1 were observed.
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    Mitigation of Aerosols Generated During Rhinologic Surgery: A Pandemic-Era Cadaveric Simulation
    (SAGE Publications, 2020-08-11) Sharma, Dhruv; Ye, Michael J.; Campiti, Vincent J.; Rubel, Kolin E.; Higgins, Thomas S.; Wu, Arthur W.; Shipchandler, Taha Z.; Sim, Michael W.; Burgin, Sarah J.; Illing, Elisa A.; Park, Jae Hong; Ting, Jonathan Y.; Otolaryngology -- Head and Neck Surgery, School of Medicine
    Objective: After significant restrictions initially due to the COVID-19 pandemic, otolaryngologists have begun resuming normal clinical practice. However, the risk of SARS-CoV2 transmission to health care workers through aerosolization and airborne transmission during rhinologic surgery remains incompletely characterized. The objective of this study was to quantify the number concentrations of aerosols generated during rhinologic surgery with and without interventions involving 3 passive suction devices. Study Design: Cadaver simulation. Setting: Dedicated surgical laboratory. Subjects and Methods: In a simulation of rhinologic procedures with and without different passive suction interventions, the concentrations of generated aerosols in the particle size range of 0.30 to 10.0 mm were quantified with an optical particle sizer. Results: Functional endoscopic sinus surgery with and without microdebrider, high-speed powered drilling, use of an ultrasonic aspirator, and electrocautery all produced statistically significant increases in concentrations of aerosols of various sizes (P \.05). Powered drilling, ultrasonic aspirator, and electrocautery generated the highest concentration of aerosols, predominantly submicroparticles \1 mm. All interventions with a suction device were effective in reducing aerosols, though the surgical smoke evacuation system was the most effective passive suction method in 2 of the 5 surgical conditions with statistical significance (P \.05). Conclusion. Significant aerosol concentrations were produced in the range of 0.30 to 10.0 mm during all rhinologic procedures in this cadaver simulation. Rhinologic surgery with a passive suction device results in significant mitigation of generated aerosols.
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    Rapid prototype feasibility testing with simulation: Improvements and updates to the Taiwanese “aerosol box”
    (Elsevier, 2020-06-04) Cartwright, Johnny; Boyer, Tanna J.; Hamilton, Matthew C.; Ahmed, Rami A.; Mitchell, Sally Ann; Anesthesia, School of Medicine
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    SARS-CoV-2 Transmission and the Risk of Aerosol Generating Procedures
    (American Thoracic Society, 2020-06-30) Pasnick, Susan; Carlos, W. Graham; Dela Cruz, Charles S; Gross, Jane E.; Garrison, Garth; Jamil, Shazia; Medicine, School of Medicine