AdenoidectomyNCT07527260
Effects of Adenoidectomy on Symptoms and IgE Levels in Children With AR
A study testing Drug therapy (NASONEX nasal spray), Adenoidectomy and Adenotonsillectomy in people with Adenoidectomy and Tonsillectomy, run by Tongji Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Adenoidectomy, Tonsillectomy, Allergic Rhinitis
- What is being tested?
- Drug therapy (NASONEX nasal spray), Adenoidectomy and Adenotonsillectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 3-12 years
- Children with physician-diagnosed allergic rhinitis and typical symptoms (nasal obstruction, watery rhinorrhea, paroxysmal sneezing);
- Co-existing adenoidal and tonsillar hypertrophy meeting surgical indications;
- No systemic or topical corticosteroids, leukotriene antagonists, or antihistamines within the past 3 months.
Who cannot join
- Prior adenoidectomy, tonsillectomy, or radio-frequency ablation;
- Nasal polyps, cystic fibrosis, primary ciliary dyskinesia, fungal rhinosinusitis, systemic vasculitis/granulomatosis, tumor, or immunodeficiency;
- Endoscopic nasal surgery within 6 months or severe asthma precluding surgery;
- Upper respiratory infection within 4 weeks;
- Serious metabolic, cardiovascular, immune, neurologic, hematologic, gastrointestinal, cerebrovascular, or respiratory disease, or any condition judged by the investigator to interfere with outcome assessment or participant safety;
- Currently enrolled or within 30 days of participation in another clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Yin Yao, 86 15071077020, Dr.yaoyin@hotmail.com
About this study
Official title: Effects of Adenoidectomy With or Without Tonsillectomy on Symptoms and Local IgE Levels in Children With Allergic Rhinitis
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.
- Conditions
- Adenoidectomy, Tonsillectomy, Allergic Rhinitis
- Being tested
- Drug therapy (NASONEX nasal spray), Adenoidectomy, Adenotonsillectomy
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug therapy (NASONEX nasal spray)Drug
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.
AdenoidectomyProcedure or surgery
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.
AdenotonsillectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Drug therapy | Active comparator | 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. Receives: Drug: Drug therapy (NASONEX nasal spray) |
| Adenoidectomy and drug therapy | Experimental | Not described Receives: Drug: Drug therapy (NASONEX nasal spray); Procedure: Adenoidectomy |
| Adenotonsillectomy and drug therapy | Experimental | Not described Receives: Drug: Drug therapy (NASONEX nasal spray); Procedure: Adenotonsillectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: 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.
Secondary outcomes (5)
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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: Within 6 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start11 Apr 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenoidectomyStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yin Yao, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527260
- Sponsor's protocol ID
- TJ-IRB202508035
- Status last verified
- Apr 2026
- First submitted
- 21 Sep 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adenoidectomy With or Without Tonsillectomy on Symptoms and Local IgE Levels in Children With Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT07527260
- Acronym / sponsor ID
- TJ-IRB202508035
- Conditions
- Adenoidectomy, Tonsillectomy, Allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 11 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Drug therapy | Active comparator | Drug: Drug therapy (NASONEX nasal spray)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. |
| Adenoidectomy and drug therapy | Experimental | Drug: Drug therapy (NASONEX nasal spray), Procedure: Adenoidectomy |
| Adenotonsillectomy and drug therapy | Experimental | Drug: Drug therapy (NASONEX nasal spray), Procedure: Adenotonsillectomy |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 3-12 years
- Children with physician-diagnosed allergic rhinitis and typical symptoms (nasal obstruction, watery rhinorrhea, paroxysmal sneezing);
- Co-existing adenoidal and tonsillar hypertrophy meeting surgical indications;
- No systemic or topical corticosteroids, leukotriene antagonists, or antihistamines within the past 3 months.
Key exclusion criteria (6 listed)
- Prior adenoidectomy, tonsillectomy, or radio-frequency ablation;
- Nasal polyps, cystic fibrosis, primary ciliary dyskinesia, fungal rhinosinusitis, systemic vasculitis/granulomatosis, tumor, or immunodeficiency;
- Endoscopic nasal surgery within 6 months or severe asthma precluding surgery;
- Upper respiratory infection within 4 weeks;
- Serious metabolic, cardiovascular, immune, neurologic, hematologic, gastrointestinal, cerebrovascular, or respiratory disease, or any condition judged by the investigator to interfere with outcome assessment or participant safety;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug therapy (NASONEX nasal spray)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 | Adenoidectomy and drug therapy, Adenotonsillectomy and drug therapy, Drug therapy |
| AdenoidectomyLow-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. | Procedure or surgery | Adenoidectomy and drug therapy |
| AdenotonsillectomyLow-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. | Procedure or surgery | Adenotonsillectomy and drug therapy |
Primary outcome
Symptom scores
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.
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)
Allergen-Specific IgE Levels in Nasal Cavity
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.
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).
5 secondary outcomes
Serum IgE Levels
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
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
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
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
Time frame: Within 6 months after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug therapy (NASONEX nasal spray), Adenoidectomy and Adenotonsillectomy in people with Adenoidectomy and Tonsillectomy, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yin Yao (+8615071077020, Dr.yaoyin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom scores (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.