RANDOMIZED CONTROL STUDY TO ANALYSE THE EFFICACY BUDESONIDE NASAL DOUCHING ON ALLERGIC FUNGAL RHINOSINUSITIS

Abstract

ABSTRACTINTRODUCTIONAllergic Fungal Rhinosinusitis is a hypersensitivity against fungal antigens. Primary surgical management is complimented with medical management in preoperative and postoperative phases for better intraoperative field & to limit the recurrence. The effect of systemic steroids & itraconazole showed promising outcomes as a solo agent or in combination under preoperative status. Recent studies showed auspicious conclusions with steroid-based nasal douches. The current study aims to assess the effectiveness of medical management in combination with steroid-based nasal douches.METHODOLOGYThis prospective study will recruit 40 clinico-radiological proven cases of AFRS after ethical approval. The study population will be randomized into two groups based on a computer program. Group A will receive systemic itraconazole and steroids & Group B will receive additional budesonide nasal douching. The outcomes will be studied clinically by SNOT-22 scoring system & Meltzer nasal polyp scoring system, biochemically with absolute eosinophil counts, aspergillus specific IgE and total IgE, radiologically with Lund-Mackay system and 20-point CT scoring system after 6 weeks of initiation of the treatment.ETHICS AND DISSEMINATIONWe received an AIIMS ethical board. Ref no-AIIMSA00641 dated 21.03.24 & CTRI (Clinical Trial Registry India) acknowledgement number - REF/2024/03/081566 dated 29. 03.24. We will follow the ethical committee protocol and instructions received from reviewers.STRENGTHSAFRS is a bothersome illness both for treating doctors and patients. This study is a pilot study on a combination of past and recently proven medical therapies for AFRS.The study will generate data on new or complete medical management for AFRS.The duration of planned treatment is 6 weeks. The study will generate data for future studies where prolonged medical treatment can be planned.LIMITATIONSThis will be a single-centred study. The validation for the expected outcome will require a multicentric study.The study topic is planned for an MS student thesis so the follow-up period will be 3-6 months.