Randomized control study to analyse the efficacy budesonide nasal douching on allergic fungal rhinosinusitis

INTRODUCTION Allergic 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. METHODOLOGY This 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 DISSEMINATION We 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. STRENGTHS 1. AFRS 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. 2. The study will generate data on new or complete medical management for AFRS. 3. The duration of planned treatment is 6 weeks. The study will generate data for future studies where prolonged medical treatment can be planned. LIMITATIONS 1. This will be a single-centred study. The validation for the expected outcome will require a multicentric study. 2. The study topic is planned for an MS student thesis so the follow-up period will be 3-6 months. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial AIIMSA00641; CTRI/2024/03/081566 ### Funding Statement This study did not receive any funding ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: We received an AIIMS, NEW DELHI 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. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors