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Study on the Efficacy and Safety of Intratonsillar Immunotherapy for Allergic Rhinitis

Study on the Efficacy and Safety of Intratonsillar Immunotherapy for Allergic Rhinitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120247
Enrollment
Unknown
Registered
2026-03-11
Start date
2026-03-20
Completion date
Unknown
Last updated
2026-03-16

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

Conditions

allergic rhinitis

Interventions

Control Group (SCIT):Subcutaneous Immunotherapy (SCIT)
Experimental Group (ITIT):Intratonsillar Immunotherapy (ITIT)

Sponsors

The Fifth Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Voluntarily participate in the study and sign the informed consent form; 2.Aged 18 to 65 years old and meeting the diagnostic criteria for AR; 3.A history of moderate to severe AR, with a Total Nasal Symptom Score (TNSS) of >= 6 points in the recent 3 months; 4.Positive skin prick test (SPT); 5.Serum-specific IgE antibody test for HDM > 3.5 kU/L; 6.Poor response to standard pharmacotherapy; 7.Willing to receive AIT; 8.Able to communicate well with the researchers and comply with all trial requirements;

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating patients; 2.Patients with uncontrolled severe cardiovascular, hepatic, or renal diseases (e.g., unstable angina, NYHA Class III–IV heart failure, severe hepatic or renal dysfunction); 3.Patients taking medications that may interfere with immune responses; 4.Patients who received immunotherapy within the past 3 years prior to enrollment; 5.Patients with tonsillar atrophy in whom intratonsillar injection is technically difficult; 6.Patients with chronic tonsillitis, peritonsillar abscess, or moderate to severe palatine tonsillar hypertrophy who are not suitable for intratonsillar injection; 7.Patients who have undergone nasal surgery; 8.Patients with unreasonable expectations of treatment efficacy or poor compliance;

Design outcomes

Primary

MeasureTime frame
Change from baseline in TNSS (?TNSS);Mini-Rhinoconjunctivitis Quality of Life Questionnaire (Mini-RQLQ);Incidence of Adverse Events;Total Nasal Symptom Score Score (TNSS);Visual Analogue Scale for Nasal Symptoms Score (VAS);Combined Symptom and Medication Score (CSMS);

Secondary

MeasureTime frame
Serum Der p-specific IgG4;Serum Der p-specific IgE;Skin Prick Test (SPT);

Countries

China

Contacts

Public ContactHaiyu Hong

The Fifth Affiliated Hospital of Sun Yat-sen University

honghy@sysu.edu.cn+86 756 2528832

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026