Background: Inhaled nasal corticosteroid sprays (INS) are often inadequate to treat chronic rhinosinusitis (CRS). The exhalation delivery system with fluticasone (EDS-FLU; XHANCE®) may improve outcomes in CRS by increasing medication delivery to target superior/posterior anatomic sites. This study assessed safety and efficacy of EDS-FLU in a large population with moderate-tosevere CRS with or without nasal polyps (CRSwNP, CRSsNP). Methods: Prospective, multicenter, 12-week, single-arm study of EDS-FLU 372 µg twice daily (BID) at 38 U.S. sites. Safety was assessed by adverse-event evaluations, nasal endoscopy, and ocular examinations. Efficacy was serially assessed by outcomes including nasal endoscopy (Lund-Kennedy Score, polyp grade), patient-and physician-reported outcomes (22-item Sinonasal Outcome Test [SNOT-22]), study-defined surgical indicator assessment, and Patient Global Impression of Change (PGIC). Results: 705 comparatively refractory subjects were enrolled, 603 CRSsNP and 102 CRSwNP [moderate-to-severely symptomatic; baseline SNOT-22 ~43, high rates of prior INS use (92.3%) and/or prior surgery (27.5%)]. More than 90% reported improvement on treatment by PGIC. SNOT-22 scores improved substantially and similarly in patients with NP (-23.7) and without NP (-24.4). Among patients with baseline Lund-Kennedy edema scores >0, 33.3% (CRSwNP) and 54.8% (CRSsNP) had complete resolution of edema. In CRSwNP patients, 48% had polyp elimination in ≥1 nostril, 63% had ≥1-point improvement in polyp grade, mean bilateral polyp grade decreased from 2.9 to 1.6, and study-defined surgical eligibility decreased. EDS-FLU was generally well tolerated, with a safety profile similar to conventional INS sprays when used to treat CRS. Conclusion: EDS-FLU 372 µg BID in the treatment of CRS with or without polyps was safe, well-tolerated, and produced substantial improvement across a broad range of both objective and subjective measures.
Background: Describing SARS-CoV-2 testing and positivity trends among urgent care users is crucial for understanding the trajectory of the pandemic. Objective: To describe demographic and clinical characteristics, positivity rates, and repeat testing patterns among patients tested for SARS-CoV-2 at CityMD, an urgent care provider in the New York City metropolitan area. Design: Retrospective study of all persons testing for SARS-CoV-2 between March 1, 2020 and January 8, 2021 at 115 CityMD locations in the New York metropolitan area. Patients: Individuals receiving a SARS-CoV-2 diagnostic or serologic test. Measurements: Test and individual level SARS-CoV-2 positivity by PCR, rapid antigen, or serologic tests. Results: During the study period, 3.4 million COVID tests were performed on 1.8 million individuals. In New York City, CityMD diagnosed 268,298 individuals, including 17% of all reported cases. Testing levels were higher among 20-29 year olds, non-Hispanic Whites, and females compared with other groups. About 24.8% (n=464,902) were repeat testers. Test positivity was higher in non-Hispanic Black (6.4%), Hispanic (8.0%), and Native American (8.0%) patients compared to non-Hispanic White (5.4%) patients. Overall seropositivity was estimated to be 21.7% (95% Confidence Interval [CI]: 21.6-21.8) and was highest among 10-14 year olds (27.3%). Seropositivity was also high among non-Hispanic Black (24.5%) and Hispanic (30.6%) testers, and residents of the Bronx (31.3%) and Queens (30.5%). Using PCR as the gold standard, SARS-CoV-2 rapid tests had a false positive rate of 5.4% (95%CI 5.3-5.5). Conclusion: Urgent care centers can provide broad access to critical evaluation, diagnostic testing and treatment of a substantial number of ambulatory patients during pandemics, especially in population-dense, urban epicenters.
Egg allergy is a contraindication for influenza vaccination because of the presence of trace egg protein. Although recent reports suggest that egg-allergic individuals can be safely immunized with seasonal influenza vaccine, the safety of H1N1 influenza vaccine in this context has not previously been reported. This study was designed to investigate how to safely immunize high-risk populations during the H1N1 influenza pandemic for whom the vaccine would be contraindicated. Vaccination of egg-allergic children was conducted at a large, multispecialty practice. Pediatricians raised awareness of vaccination and referred egg-allergic individuals to allergists. Allergists performed skin testing to H1N1 vaccine and, if negative, performed graded vaccine desensitizations in the office. Mass immunization of egg-allergic individuals was achieved within a 3-week period after receipt of vaccine. Sixty-three children (average age, 3.7 years) were evaluated and skin tested to the H1N1 influenza vaccine. All had a clinical history of egg allergy and recent positive skin-prick to egg. All had negative skin-prick test to the H1N1 vaccine and received graded challenge with three divided doses. All 62 children were successfully immunized without allergic reactions. Vaccination of egg-allergic individuals during a pandemic can be safely and efficiently accomplished with the coordination of multidisciplinary resources. Although this was conducted at a multispecialty practice, we believe that this invaluable public health service can be done outside of this context. Allergists, with the help of local pediatricians and urgent care centers or hospitals, can effectively mobilize to help protect the most vulnerable populations during pandemics.
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