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IRCT20241023063479N1 IRCT 2025-01-06 Bagheiat-allah University of Medical Sciences Comparison of the effect of fluticasone and fluticasone-azelastine spray on clinical and radiological symptoms of adenoid hypertrophy. Efficacy comparison between topical fluticasone combined with azelastine and fluticasone alone on clinical symptoms and radiologic finding in children with adenoid hypertrophy 2025-01-20 anticipated 60 Complete https://irct.ir/trial/80547 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Quadruple block randomization using sealed envelopes After the patients enter the clinic and after the initial assessment and meeting the conditions for entry into the study, after explaining the design and obtaining consent, one envelope is randomly selected from among the four envelopes whose contents are written (fluticasone group, fluticasone group, fluticasone-azelastine group, fluticasone-azelastine group) and is placed in the control and intervention groups based on it. After completing the first block or set of four envelopes, four other envelopes with the same content are prepared and then randomly selected. The blocks of four are repeated until a final 60 data are collected (15 blocks of four, each block having two control groups and two intervention groups), Blinding description: Participant,Investigator and Data analyser a blind. After the patient's eligibility for the study is confirmed, the data collector selects and opens the sealed envelope and, based on the contents inside the envelope, places the patient in the intervention or control group. The patient will not be informed of the group they are placed in. The data collector is different from the analyst, and after collecting the data, only the information will be given to them as a and b without specifying the control and intervention groups. The researcher is also different from the analyst and data collector, and will not be informed of the control and intervention groups in the selection process and statistical results. 3 Adenoid hypertrophy. Intervention 1: Control group or fluticasone: A group of patients who use fluticasone nasal spray twice a day at a dose of 50ug for 6 weeks. Then clinical symptoms and lateral neck radiography and audiometry are repeated, then the drug is discontinued for 6 weeks and then clinical symptoms are asked. Intervention 2: Intervention group or fluticasone-azelastine:A group of patients who use fluticasone-azelastine nasal spray twice a day at a dose of 137ug/50ug for 6 weeks. Then clinical symptoms and lateral neck radiography and audiometry are repeated, then the medication is discontinued for 6 weeks and then clinical symptoms are asked. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is "There is no further information"
public Zohreh Ajalloueyan
Sheykh bahayi St, Vanak Sq, Mollasadra St
Tehran Iran (Islamic Republic of) 14359 15371 +98 21 8755 5000 Zohrehajall@gmail.com Bagheiat-allah University of Medical Sciences scientific Zohreh Ajalloueyan
Sheykh bahayi St, Vanak Sq, Mollasadra St
Tehran Iran (Islamic Republic of) 14359 15371 +98 21 8755 5000 Zohrehajall@gmail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Age 4 to 12 years Adenoid obstruction of at least 50% of the nasopharynx on lateral neck radiography with one of the symptoms of chronic nasal obstruction consistent with adenoid hypertrophy (mouth breathing, nasal discharge, snoring, chronic cough, nasal speech) Grade one or two palatine tonsils Absence of chronic tonsillitis Not having peritonsillar abscesses more than twice a year No history of previous adenoid surgery or tonsillectomy There are no contraindications to the use of topical corticosteroid in the form of a nasal spray. Patient and parent consent to participate in the study No upper respiratory infection in the past 2 weeks Absence of anatomical sinus abnormalities or diseases, craniofacial abnormalities such as cleft lip and palate, genetic diseases (e.g., Down syndrome), neurological or cardiovascular diseases, history of asthma, hypersensitivity to study drugs No steroid or antibiotic treatment, topical or systemic, in the past 4 weeks 4 years 12 years Both Grade three or four palatine tonsils Having peritonsillar abscesses more than twice a year Upper respiratory infection in the past 2 weeks History of previous adenoid surgery or tonsillectomy J35.2 Hypertrophy of adenoids Treatment - Drugs Treatment - Drugs Control group or fluticasone: A group of patients who use fluticasone nasal spray twice a day at a dose of 50ug for 6 weeks. Then clinical symptoms and lateral neck radiography and audiometry are repeated, then the drug is discontinued for 6 weeks and then clinical symptoms are asked. Intervention group or fluticasone-azelastine:A group of patients who use fluticasone-azelastine nasal spray twice a day at a dose of 137ug/50ug for 6 weeks. Then clinical symptoms and lateral neck radiography and audiometry are repeated, then the medication is discontinued for 6 weeks and then clinical symptoms are asked. Adenoid size. Timepoint: At the beginning of the study (before the start of the intervention), 6 weeks after taking the drug. Method of measurement: Adenoid to choanae size ratio on lateral neck radiograph. Nasal speech. Timepoint: At the beginning of the study (before the intervention), 6 weeks after taking the drug, 6 weeks after stopping the drug. Method of measurement: Clinical symptom questionnaire. Mouth breathing. Timepoint: At the beginning of the study (before the intervention), 6 weeks after taking the drug, 6 weeks after stopping the drug. Method of measurement: Clinical symptom questionnaire. Snoring. Timepoint: At the beginning of the study (before the intervention), 6 weeks after taking the drug, 6 weeks after stopping the drug. Method of measurement: SNORING SCALE SCORE -Cambridge University. Chronic cough. Timepoint: At the beginning of the study (before the intervention), 6 weeks after taking the drug, 6 weeks after stopping the drug. Method of measurement: Clinical symptom questionnaire. Rhinorrhea. Timepoint: At the beginning of the study (before the intervention), 6 weeks after taking the drug, 6 weeks after stopping the drug. Method of measurement: Clinical symptom questionnaire. Air bone gap in audiometry. Timepoint: At the beginning of the study (before the intervention), 6 weeks after taking the drug. Method of measurement: Audiometry. Tympanometry. Timepoint: At the beginning of the study (before the start of the intervention), 6 weeks after taking the drug. Method of measurement: Tympanometry. Bagheiat-allah University of Medical Sciences Approved 2024-10-12 Ethics Committee of Baqiyatallah University of Medical Sciences Sheykh bahayi St, Vanak Sq, Mollasadra St, Tehran Tehran Tehran Iran (Islamic Republic of)