An interventional study of Drug therapy (NASONEX nasal spray) and Adenoidectomy in Adenoidectomy, Tonsillectomy and Allergic Rhinitis, sponsored by Tongji Hospital. Not yet recruiting at 1 site in China. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Tongji Hospital · Not applicable, Interventional, and Treatment
This study aims to evaluate the effects of conservative management versus surgical intervention (adenoidectomy alone or adenotonsillectomy) on symptoms and local IgE levels in children with allergic rhinitis (AR) accompanied with adenotonsillar hypertrophy. The primary objectives include the impact of conservative management and surgical interventions on AR symptoms and local IgE levels. The second outcomes include serum IgE levels, inflammatory cell profiles within the nasal mucosa, and postoperative complications.
717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.
This study's planned enrollment of 36 is below the median of 68 across 552 interventional studies indexed under Rhinitis, Allergic.
Browse Rhinitis, Allergic studies →Tongji Hospital is the lead sponsor of 386 studies on the registry; 209 are open to participants now.
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- 3-12 years
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Medical therapy with daily administration of NASONEX nasal spray (50 µg per nostril, once every morning). Treatment was maintained for four weeks, with scheduled follow-up visits to evaluate efficacy and monitor adverse reactions.
Drug: Drug therapy (NASONEX nasal spray)
Drug: Drug therapy (NASONEX nasal spray) · Procedure: Adenoidectomy
Drug: Drug therapy (NASONEX nasal spray) · Procedure: Adenotonsillectomy
Medical therapy with daily administration of NASONEX nasal spray (50 µg per nostril, once every morning). Treatment was maintained for four weeks, with scheduled follow-up visits to evaluate efficacy and monitor adverse reactions.
Low-temperature plasma adenoid ablation is a minimally invasive procedure performed under general anesthesia. After induction, the nose and face are disinfected and draped in the usual manner; a Davis mouth-gag is inserted and the soft palate is retracted with two fine suction catheters. The surgeon holds a disposable low-temperature plasma wand in the right hand and a 70° nasopharyngoscope in the left, then systematically ablates the hypertrophic adenoid tissue from inferior to superior and from center to periphery; the entire ablation takes approximately 10 min. Hemostasis is obtained with targeted cautery, the scope is withdrawn, and the operation is concluded. The technique produces minimal trauma, little bleeding, and rapid recovery. Medical therapy with daily administration of NASONEX nasal spray (50 µg per nostril, once every morning). Treatment was maintained for four weeks, with scheduled follow-up visits to evaluate efficacy and monitor adverse reactions.
Low-temperature plasma adenoidectomy begins with general anesthesia for the patient. The surgeon holds a disposable low-temperature plasma electrode in the right hand and a 70° nasal endoscope in the left hand (inserted through the mouth), and gradually ablates the hypertrophic adenoidal tissue from bottom to top and from the center to the periphery. The entire procedure takes approximately 10 minutes. After ablation is completed, electrocoagulation is used for local hemostasis. Medical therapy with daily administration of NASONEX nasal spray (50 µg per nostril, once every morning). Treatment was maintained for four weeks, with scheduled follow-up visits to evaluate efficacy and monitor adverse reactions.
Symptom scores
Record self-assessed AR symptom scores including nasal congestion, runny nose, nasal itching, sneezing, itching and burning eyes, tearing and watering eyes, and eye redness. Each symptom was scored from 0 to 3 (0, no symptom; 1, mild symptom; 2, moderate symptom; and 3, severe symptom)
Time frame: Surgery Group: at baseline (Pre-surgery) and at 1, 3, and 6 months post-surgery; Medication Group: at baseline (Pre-treatment ) and at 1, 3, and 6 months post-treatment initiation.
Allergen-Specific IgE Levels in Nasal Cavity
Measures the change in allergen-specific IgE (sIgE) levels in nasal cavity to evaluate the regulation of local allergic responses. * For the Surgery Group: Samples (nasal mucosa samples via endoscopic biopsy, nasopharyngeal swab samples) are collected before surgery (baseline) and at 1, 3, 6 months after surgery. * For the Medication Group: Samples are collected before medication initiation (baseline) and at 1, 3, 6 months after medication initiation. sIgE levels are detected using immunoassay techniques (e.g., ELISA). Results are reported as standardized concentration units (e.g., kU/L).
Time frame: Surgery Group: at baseline (Pre-surgery) and at 1, 3, and 6 months post-surgery; Medication Group: at baseline (Pre-treatment ) and at 1, 3, and 6 months post-treatment initiation.
Serum IgE Levels
Assesses systemic allergic status via blood samples. * For the Surgery Group: Venous blood samples are collected before surgery (baseline) and at 1, 3, 6 months after surgery. * For the Medication Group: bloods are collected before medication initiation (baseline) and at 1, 3, 6 months after medication initiation. * Serum IgE levels are detected. Results are reported as "IU/mL" (IgE).
Time frame: Surgery Group: at baseline (Pre-surgery) and at 1, 3, and 6 months post-surgery; Medication Group: at baseline (Pre-treatment ) and at 1, 3, and 6 months post-treatment initiation.
Numbers and Proportions of Inflammatory cells in Nasal Cavity
Assesses the changes in the absolute number and relative proportion of inflammatory cells in the nasal cavity. Nasopharyngeal swabs are used to collect samples (sampling method: subjects sit, blow their noses, close their eyes to relax; professional doctors insert swabs to nasal cavity, rotate 5 times, stay for 10-15 seconds, and place swabs into 2mL RPMI medium containing 10% fetal bovine serum). Inflammatory cells are quantified by flow cytometry.
Time frame: Surgery Group: at baseline (Pre-surgery) and at 1, 3, and 6 months post-surgery; Medication Group: at baseline (Pre-treatment ) and at 1, 3, and 6 months post-treatment initiation.
Nasal Endoscopy Scores
Rates nasal mucosal and structural changes via nasal endoscopy, with scored signs including mucosal edema, secretions, crusting, scarring, and nasal ventilation.The total score is the sum of individual sign scores; changes from baseline indicate nasal mucosal recovery and ventilation improvement.
Time frame: Surgery Group: at baseline (Pre-surgery) and at 1, 3, and 6 months post-surgery; Medication Group: at baseline (Pre-treatment ) and at 1, 3, and 6 months post-treatment initiation.
Inflammatory Cytokine Levels in Nasal Secretions
Measures changes in inflammatory cytokine levels (e.g., IL-5, IL-13) in nasal secretions to evaluate local inflammatory responses. * For the Surgery Group: Nasal secretions are collected via nasal swabs before surgery (baseline) and at 1, 3, 6 months after surgery. * For the Medication Group: Nasal secretions are collected before medication initiation (baseline) and at 1, 3, 6 months after medication initiation. Cytokine levels are quantified by immunoassay (e.g., ELISA), reported as "pg/mL" to reflect the regulation of local nasal inflammation by intervention (surgery/medication).
Time frame: Surgery Group: at baseline (Pre-surgery) and at 1, 3, and 6 months post-surgery; Medication Group: at baseline (Pre-treatment ) and at 1, 3, and 6 months post-treatment initiation.
Surgical Complications
Record Surgical Complications
Time frame: Within 6 months after surgery.
Plan to share: Undecided
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