]>
IRCT20200718048126N2 IRCT 2026-10-01 Vice-Chancellery for Research and Technology, Guilan University of Medical Sciences Comparison of the Effectiveness of Combined Fluticasone and Azelastine Spray with Fluticasone and Azelastine Single-Agent Sprays in Children with Adenoid Hypertrophy Efficacy of Combined Spray (Fluticasone + Azelastine) Spray versus Single-Agent Use of Fluticasone Spray and Azelastine Spray in Improving Clinical Symptoms and Adenoid Size in Children with Adenoid Hypertrophy - Clinical Trial 2026-10-07 anticipated 90 Recruiting https://irct.ir/trial/92469 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: Randomization will be performed using blocks of six and sealed envelopes. After the patients are admitted to the hospital, undergo an initial evaluation, and meet the inclusion criteria, the study design will be explained to them and informed consent will be obtained. The patients will then be randomly allocated in a 1:1:1 ratio using PASS 11.0 in blocks of six. For each block, one envelope will be randomly selected from six sealed envelopes containing the group assignments: two envelopes for the fluticasone group, two envelopes for the combination spray group, and two envelopes for the azelastine group. The patients will be assigned to the corresponding treatment groups according to the selected envelope. After completion of the first block or set of six envelopes, another set of six envelopes with the same contents will be prepared and randomly selected. The six-patient blocks will be repeated until the required sample size has been reached and all data have been collected, Blinding description: Due to the nature of the interventions used in this study, blinding of the study participants will not be possible, and the patients and their parents will be aware of the type of medication received. However, the study will be conducted as a single-blind study with respect to outcome assessors and data analyser; accordingly, the assessors will be blinded to the patients’ group allocation. After obtaining informed consent and confirming the patient’s eligibility, allocation to one of the three study groups will be performed using opaque, non-transparent, sequentially numbered, and sealed envelopes. The designated person responsible for allocation will open the corresponding envelope, and the patient will be assigned to one of the three study groups according to its contents. Information regarding the assigned study group will not be disclosed to the outcome assessors until the completion of outcome assessment. 3 Patients with adenoid hypertrophy. Intervention 1: First intervention group: Combination azelastine/fluticasone nasal spray: 137/50 µg per spray; one spray into each nostril twice daily for 12 weeks. Intervention 2: Intervention groupsecond intervention group: Fluticasone nasal spray: 50 µg per spray; one spray into each nostril twice daily for 12 weeks.:. Intervention 3: Third intervention group: Azelastine nasal spray: 137 µg per spray; one spray into each nostril twice daily for 12 weeks. Yes - There is a plan to make this available What will be shared: Data sharing will be conducted comprehensively and will include all variables mentioned above, rather than being limited solely to the primary outcomes. Following the removal of all direct identifiers (such as names, medical record numbers, and national identification numbers) and in accordance with ethical considerations, these data will be made available to researchers for valid research purposes. When: Access to the research data and study documentation will commence upon completion of the study and following the publication of the initial findings in a scientific article. To whom: After the end of the study period, the results will be available to the public in the form of articles Conditions: If published as an article Where to obtain: ENT Research Center of Guilan University of Medical Sciences How to obtain: In-person referral or electronic request to the ENT Research Center of Guilan University of Medical Sciences Comments:
public Maryam Akbari
Rasht, 17 Shahrivar Street, Amir Al-Momenin Hospital
rasht Iran (Islamic Republic of) 4193784751 +98 13 3322 5242 maryamakbari_6699@yahoo.com Rasht University of Medical Sciences scientific Maryam Akbari
Rasht, 17 Shahrivar Street, Amir Al-Momenin Hospital
rasht Iran (Islamic Republic of) 4193784751 +98 13 3322 5242 maryamakbari_6699@yahoo.com Rasht University of Medical Sciences Iran (Islamic Republic of) Children aged 6–12 years with a diagnosis of adenoid hypertrophy, confirmed by clinical symptoms and physical examination, nasal endoscopy, and lateral cephalometric radiography, who present to Amiralmomenin Educational and Medical Center in Rasht, will be enrolled in the study. These children must have experienced at least one of the following clinical symptoms for a minimum of 3 months: chronic nasal obstruction, nocturnal snoring, mouth breathing, rhinorrhea, cough, or hyponasal speech. The palatine tonsils must be normal in size or classified as Grade 1–2. The children must not have an indication for tonsillectomy due to chronic tonsillar inflammation. 6 years 12 years Both Children who have used systemic or topical corticosteroids, decongestants, or antihistamines within the previous 2 weeks Children with a known hypersensitivity to fluticasone or azelastine. Children with severe underlying medical conditions, such as uncontrolled asthma, cardiac or hepatic diseases, immunodeficiency disorders, craniofacial anomalies including cleft lip and palate, genetic disorders (such as Down syndrome), or neurological disorders. Children with an active respiratory or sinus infection requiring antibiotic treatment, or those who use other antiallergic medications or corticosteroids during the study. Children who do not adhere to the treatment protocol. Children with Grade 3 or 4 palatine tonsils, a history of peritonsillar abscess occurring more than twice a year, or an upper respiratory tract infection within the previous 2 weeks. Children with a history of previous adenoid surgery or tonsillectomy. J35.2 Hypertrophy of adenoids Treatment - Drugs Treatment - Drugs Treatment - Drugs First intervention group: Combination azelastine/fluticasone nasal spray: 137/50 µg per spray; one spray into each nostril twice daily for 12 weeks. Intervention groupsecond intervention group: Fluticasone nasal spray: 50 µg per spray; one spray into each nostril twice daily for 12 weeks.: Third intervention group: Azelastine nasal spray: 137 µg per spray; one spray into each nostril twice daily for 12 weeks. Clinical symptom severity of adenoid hypertrophy will be assessed using the Berlucchi criteria at baseline and at weeks 4, 8, and 12 and compared among the three groups. Adenoid size will also be assessed by nasal endoscopy and lateral neck radiography at baseline and at week 12, and changes will be compared among the three. Timepoint: Outcome variables will be assessed at baseline and at weeks 4, 8, and 12. Method of measurement: Outcome variables will be assessed using the Berlucchi criteria, nasal endoscopy, lateral neck radiography, and a quality-of-life questionnaire. Clinical symptom severity of adenoid hypertrophy will be assessed using the Berlucchi criteria at baseline and at weeks 4, 8, and 12 and compared among the three groups. Adenoid size will also be assessed by nasal endoscopy and lateral neck radiography at baseline and at week 12, and changes will be compared among the three. Timepoint: Outcome variables will be assessed at baseline and at weeks 4, 8, and 12. Method of measurement: Outcome variables will be assessed using the Berlucchi criteria, nasal endoscopy, lateral neck radiography, and a quality-of-life questionnaire. none Approved 2026-04-08 Ethics Committee of Guilan University of Medical Sciences Namjoo Street – Shahid Sayyadi Street – Opposite 17 Shahrivar Hospital – Vice-Chancellery for Research and Technology of the University rasht Guilan Iran (Islamic Republic of)