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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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241023063479N1
Enrollment
60
Registered
2025-01-06
Start date
2025-01-20
Completion date
Unknown
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenoid hypertrophy. Hypertrophy of adenoids

Interventions

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 aud

Sponsors

Bagheiat-allah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 12 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZohreh Ajalloueyan

Bagheiat-allah University of Medical Sciences

Zohrehajall@gmail.com+98 21 8755 5000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026