A Real-World Observational Study to Evaluate the Safety and Effectiveness of Fluticasone Furoate-Oxymetazoline Fixed Dose Combination Nasal Spray in Patients with Allergic Rhinitis.

BACKGROUND: Allergic rhinitis (AR) has shown an increasing prevalence leading to a considerable medical and social burden. Nasal congestion is the cardinal symptom of AR, and the upper respiratory tract is most affected by this long-lasting ailment. Intranasal corticosteroids alleviate nasal congestion, along with other symptoms of AR, but their effect is not evident immediately. Oxymetazoline has a rapid onset of action, but its use should be limited to 3-5 days. OBJECTIVE: The study aimed to evaluate the safety and effectiveness of the fixed-dose combination nasal spray containing fluticasone furoate and oxymetazoline hydrochloride (FF + OXY) 27.5/50 mcg once daily in patients with AR in a real-world clinical setting. METHODS: The study was a prospective, open-label, single-arm, multicenter, real-world observational study conducted in patients with AR for a period of 28 days. Patients (n = 388) with a diagnosis of AR were treated with a combination of FF + OXY nasal spray. Total nasal symptom score (TNSS), total ocular symptom score (TOSS) and total symptom score (TSS) were documented at baseline and at the end of study period. The overall effectiveness of treatment with FF + OXY was rated by the investigators as very good/good/satisfactory/poor (4-point Likert scale) for each patient. RESULTS: Treatment with FF + OXY resulted in significant reduction in the TNSS, TOSS and TSS, from 7.18 ± 3.38 at baseline to 0.20 ± 0.84 (p < 0.001), from 2.34 ± 2.29 at baseline to 0.09 ± 0.53 (p < 0.001), from 9.51 ± 4.94 at baseline to 0.29 ± 1.32 (p < 0.001) at 28 days respectively. With respect to effectiveness, the investigators reported very good effectiveness in 52.12% of patients. No serious adverse events were reported. CONCLUSION: The fixed-dose combination of once-daily fluticasone furoate and oxymetazoline hydrochloride nasal spray 27.5/50 mcg was effective in relieving the nasal congestion and reduction of TNSS, TOSS and TSS in patients suffering from AR. The combination was safe and well tolerated with no rebound congestion throughout the treatment period.

Risk Based Decision Algorithms for Management of COVID-19 Associated Rhino-orbital Mucormycosis.

Introduction: COVID associated mucormycosis is a challenging problem with significant morbidity and mortality implications. COVID affliction, pre-existing medical conditions especially diabetes and steroid prescription are supposed contributors for development of this opportunistic fungal infection. Surgery remains the mainstay of treatment with adequate post-op anti-fungal therapy. Materials and methods: This is a retrospective analysis of prospectively maintained database of all surgical patients between March-May 2021 at a single centre. Prognosticators such as severity of COVID affliction, use of steroids, extent of rhino-orbital mucormycosis, extent of surgery and outcomes were studied. Descriptive statistics was used to analyse frequency of different variables and chi square test was used to analyse prognostic factors. P value < 0.05 were deemed significant. Results: 74 patients with an average 30 day follow-up were included. All patients had preceding COVID infection and 71.6% were diabetic and 25.7% were diagnosed during the course of their COVID treatment. Multiple sinus involvement being most common (52.61%), 10.81% underwent orbital exenteration and 24.32% palatectomies were performed. Revision surgeries were warranted in 16.21% patients. 9 patients succumbed to disease/ underlying medical and treatment related complications. Conclusion: We propose a risk assessment based on general condition of patient and severity of mucormycosis infection to decide appropriate strategy for surgical intervention. Early detection and timely and adequate surgery are essential pre-requisites to good outcomes. Supplementary Information: The online version contains supplementary material available at 10.1007/s12070-021-02692-9.