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IRCT20200926048841N4 IRCT 2026-06-12 Shahid Beheshti University of Medical Sciences The effect of intranasal corticosteroids on the incidence of invasive fungal sinusitis Investigating the effect of intranasal corticosteroids on the incidence of invasive fungal sinusitis in patients receiving stem cell transplantation: A randomized clinical trial study 2026-03-07 anticipated 426 Complete https://irct.ir/trial/89280 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method. Given the block size of 2, there are two ways to assign participants to a block: AB or BA. (A) stands for fluticasone propionate spray; (B) stands for placebo spray. Using Microsoft Excel software we produce 213 numbers. For even numbers AB combination and for odd numbers BA combination are chosen, Blinding description: fluticasone propionate spray and placebo spray are identical in shape and package.Patients were blinded to which group they entered,but they were told that they could use nasal spray fluticasone propionate or placebo spray.The researcher and the author of the article are blinded to which group A or B belong to intervention group. The evaluations after the operation were performed by a person who was blinded to the patient group.The statistical analyzer was also blinded to the groups. 3 Condition 1: Stem cells transplant patient. Condition 2: Acute myeloblastic leukemia. Condition 3: Acute myeloid leukemia with multilineage dysplasia. Intervention 1: Intervention group: Patients who receive kooshan pharmed Company's fluticasone propionate nasal spray at a daily dose of 200 micrograms (100 micrograms in each nostril, twice a day) for 8 weeks. The doctor instructs patients to shake the spray before use and to keep the tip of the spray away from the nasal septum when using it inside the nose. Intervention 2: Control group: They receive a placebo nasal spray producted by koosha pharmed company containing a rinse serum that is similar in appearance to fluticasone propionate spray (one puff in each nostril twice a day) for 8 weeks. The doctor instructs patients to shake the spray before use and to keep the tip of the spray away from the nasal septum when using it inside the nose. Yes - There is a plan to make this available What will be shared: participant data sets are to be shared When: These data files will become available one year after publication To whom: The data is only available for people working in academic institutions Conditions: The data is only available for people working in academic institutions Where to obtain: The data is obtainable from the corresponder author via email How to obtain: The data is obtainable from the corresponder author via email Comments:
public Mahboobe Asadi
Taleghani hospital,Erabi Ave,Velenjak
Tehran Iran (Islamic Republic of) 1916665354 009821230311 Mahboobeh_farvardin@yahoo.com Shahid Beheshti University of Medical Sciences scientific Mahboobe Asadi
Erabi ave,Velenjak
Tehran Iran (Islamic Republic of) 1916665354 +98 21 2303 1317 mahboobeh_farvardin@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients who were at least 18 years old at the time of the study Recipients of allogeneic or autologous hematopoietic stem cell transplant in the past 3 months A persistent absolute neutrophil count of less than 1000 cells per cubic millimeter for a minimum continuous period of seven days, documented by at least two consecutive laboratory measurements 18 years no limit Both Patients who had evidence of active fungal sinusitis or previous fungal sinusitis based on clinical, radiological, or microbiological criteria, Patients taking systemic antifungal medications, including prophylactic or curative therapy History of facial trauma that required surgical intervention History of previous sinus and nose surgery Congenital anomalies of the skull and face. Patients diagnosed with chronic rhinosinusitis with or without nasal polyposis Patients with known hypersensitivity to fluticasone propionate or any component of the nasal spray formulation. Z94.84 C92.0 C92.A Stem cells transplant status Acute myeloblastic leukemia Acute myeloid leukemia with multilineage dysplasia Treatment - Drugs Placebo Intervention group: Patients who receive kooshan pharmed Company's fluticasone propionate nasal spray at a daily dose of 200 micrograms (100 micrograms in each nostril, twice a day) for 8 weeks. The doctor instructs patients to shake the spray before use and to keep the tip of the spray away from the nasal septum when using it inside the nose. Control group: They receive a placebo nasal spray producted by koosha pharmed company containing a rinse serum that is similar in appearance to fluticasone propionate spray (one puff in each nostril twice a day) for 8 weeks. The doctor instructs patients to shake the spray before use and to keep the tip of the spray away from the nasal septum when using it inside the nose. Incidence of invasive fungal sinusitis. Timepoint: before intervention and 2 months after intervention. Method of measurement: mucosal biopsy and pathology assessment. Total mortality rate. Timepoint: 2 months after intervention. Method of measurement: checking patients' record. Mortality rate because of invasive fungal sinusitis. Timepoint: 2 months after intervention. Method of measurement: mucusal biopsy and checking patients' record. Duration of hospitalization. Timepoint: 2 months after intervention. Method of measurement: checking patients' record. Duration of hospitalization in ICU. Timepoint: 2 months after intervention. Method of measurement: checking patients' record. Duration of neutropenic status. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Lab tests and patients' record. Endoscopic sinus surgery rate. Timepoint: 2 months after intervention. Method of measurement: checking patients' record. Shahid Beheshti University of Medical Sciences Approved 2026-02-08 Ethics committee of Shahid Beheshti University of medical sciences Shahid Beheshti university of medical science, Erabi Ave, Velenjak , Tehran Tehran Iran (Islamic Republic of)