Randomized, placebo controlled, double blinded pilot superiority phase 2 trial to evaluate the effect of curcumin in moderate to severe asthmatics.

BACKGROUND: Curcumin, a derivative of the spice turmeric, has been adopted by Eastern medicine for centuries as an adjunct to treat several medical conditions (e.g., anorexia and arthritis) because of its well-established anti-inflammatory properties. Studies have shown that the use of curcumin in mice models has led to reduction in several inflammatory markers as well as key inflammatory pathway enzymes. As a result, studies in Western medicine have developed to determine if this recognized benefit can be utilized for patients with inflammatory lung diseases, such as asthma. This study will seek to better understand if curcumin can be used as an adjunctive therapy for improving asthma control of patients with moderate to severe asthma; a finding we hope will allow for a more affordable treatment. METHODS: This study will utilize a randomized, placebo controlled, double blinded pilot superiority phase 2 trial at an outpatient pulmonary clinic in Southern California, USA. Subjects will be receiving Curcumin 1500 mg or matching placebo by mouth twice daily for the study period of 12 weeks. Subjects will be randomized to either a placebo or intervention Curcumin. Subjects will have 6 clinic visits: screening visit, a baseline visit, monthly clinic visits (weeks 4, 8, and 12), at weeks 4, 8, and a follow-up clinic visit or phone-call (week 16). Changes in asthma control test scores, number of days missed from school/work, FEV1 (% predicted), FEV1/FVC ratio, FVC (% predicted), blood eosinophil count, blood total IgE, and FeNO levels will be compared by group over time. DISCUSSION: The therapeutic effects of curcumin have been studied on a limited basis in asthmatics and has shown mixed results thus far. Our study hopes to further establish the benefits of curcumin, however, there are potential issues that may arise from our study design that we will address within this paper. Moreover, the onset of the COVID-19 pandemic has resulted in safety concerns that have delayed initiation of our study. This study will contribute to existing literature on curcumin's role in reducing lung inflammation as it presents in asthmatics as well as patients suffering from COVID-19. TRIAL REGISTRATION: This study protocol has been approved by the Institutional Review Board at Loma Linda University Health, (NCT04353310). IND# 145101 Registered April 20th, 2020. https://clinicaltrials.gov/ct2/show/NCT04353310 .

The association of lung cancer with pulmonary fibrosis.

In this study using a large database of US decedents, the overall presence of lung cancer was lower in those with idiopathic pulmonary fibrosis compared to those without idiopathic pulmonary fibrosis https://bit.ly/30d6dC4.

COVID-19 Infection Or Buttock Injections? the Dangers of Aesthetics and Socializing During a Pandemic.

Introduction: Silicone (polydimethylsiloxane) injections are used for cosmetic augmentation. Their use is associated with life-threatening complications such as acute pneumonitis, alveolar hemorrhage, and acute respiratory distress among others [1,2]. We report a case of a Hispanic woman who developed severe respiratory distress syndrome after gluteal silicone injections. Case Presentation: A 44-year-old Hispanic female presented to the Emergency Department complaining of progressive dyspnea on exertion for two weeks. Chest imaging revealed patchy bibasilar airspace opacities of peripheral distribution. Labs were significant for leukocytosis, elevated PT, D-dimer, lactate dehydrogenase, and fibrinogen, concerning for COVID-19, however SARS-CoV-2 testing was negative multiple times. The patient later became encephalopathic, hypoxemic, and eventually required intubation. Further history uncovered that the patient had received illicit gluteal silicone injections a few days prior to her onset of symptoms. The patient was diagnosed with silicone embolism syndrome (SES) and initiated on high dose intravenous methylprednisolone [1]. Case Discussion: Patients from lower socioeconomic backgrounds utilize illicit services to receive silicone injections at minimal costs. This leads to dangerous outcomes. The serology and imaging findings observed in our case have similarities to the typical presentation of COVID-19 pneumonia making the initial diagnosis difficult. This case serves as a cautionary tale of the importance of thorough history taking in patients with concern for COVID-19.

Formation of Stable Nanobubbles on Reconstituting Lyophilized Formulations Containing Trehalose.

During an investigation of subvisible particles found in lyophilized formulations of intravenous immunoglobulin, we used resonant mass measurement techniques and discovered the presence of nanobubbles (NBs) when a 5% trehalose formulation was reconstituted. This discovery prompted studies to characterize these NBs in placebo formulations as a function of processing conditions and solution compositions. Degassing the reconstituted solutions by applying vacuum removed micron-sized bubbles but did not substantially affect the concentration of NBs. Samples that were annealed in the frozen state before lyophilization had reduced surface areas and, on reconstitution, yielded fewer NBs. Trehalose formulations with added polysorbate 20 (PS20) and formulations with higher ionic strength also had smaller numbers of NBs. Zeta potentials of the bubbles were negative in each of the formulations tested, but the negative zeta potentials were decreased in magnitude with increasing ionic strength and with addition of PS20. When incubated at 4(°)C, the number of NBs was largely unchanged at the end of 11 days, whereas the number of micron-sized bubbles gradually decreased during the 11-day incubation. Because of their exceptional stability, NBs are expected to contribute to the numbers of submicron particles that can be detected in reconstituted lyophilized protein formulations.