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To evaluate the efficacy and safety of dust mite-specific immunotherapy in allergic rhinitis: A multi-center, open, prospective, Randomized Controlled Clinical Trial (Tonsil-AIT)

To evaluate the efficacy and safety of dust mite-specific immunotherapy in allergic rhinitis: A multi-center, open, prospective, Randomized Controlled Clinical Trial (Tonsil-AIT)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100179
Enrollment
Unknown
Registered
2025-04-03
Start date
2025-04-02
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Allergic Rhinitis

Interventions

One-strength group:Subcutaneously inject Bottle No. 3 mite allergen preparation into the upper limb according to the instructions.
ITIT-A group:Referencing the literature, inject Bottle No. 1, 2, and 3 mite allergen preparations into the tonsils of AR patients, and administer maintenance treatment with Bottle No. 3 mite allergen
ITIT-B group:Referencing the literature, inject Bottle No. 1, 2, and 3 mite allergen preparations into the tonsils of AR patients, and administer maintenance treatment with Bottle No. 3 mite allergen

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Presence of typical symptoms and signs of moderate to severe perennial allergic rhinitis (AR). 2. Aged 5 to 65 years, with no gender restrictions. 3. Clinical history indicating a correlation between AR symptoms and dust mite allergens. Serum-specific IgE (sIgE) to house dust mites and/or Dermatophagoides farinae >=0.70 kU/L, and a positive (++ ) skin prick test for house dust mites and/or Dermatophagoides farinae. 4. Perennial AR primarily caused by dust mite allergy, which may be accompanied by other non-primary allergens such as cockroaches, pollen, or mold. 5. Willing to participate in this study, sign an informed consent form, demonstrate good compliance, and cooperate with follow-ups.

Exclusion criteria

Exclusion criteria: 1. Patients with unsuitable tonsils for injection. 2. Those currently using ß-blockers or ACE inhibitors in clinical practice. 3. Patients with severe metabolic, cardiovascular, immune, neurological, hematological, gastrointestinal, cerebrovascular, or respiratory diseases, such as moderate to high-risk hypertension or a history of diabetes for more than 5 years with complications. 4. Patients with allergic asthma who had an acute attack in the past six months, or those with atopic dermatitis or urticaria. 5. Patients with nasal polyps, acute or chronic sinusitis, obstructive sleep apnea-hypopnea syndrome, or other otolaryngological diseases that may affect study results or increase the treatment risk. 6. Participants in other clinical studies within the past three months. 7. Patients who have received allergen-specific immunotherapy for AR within the past three years or used any drugs that may interfere with immune responses, such as chemotherapy drugs (alkylating agents, antimetabolites, etc.), immunomodulators like antiviral interferons, interleukins, or biologics. 8. Patients with a history of life-threatening allergic reactions or angioedema. 9. Pregnant or lactating women and those planning pregnancy within one year. 10. History of malignant tumors. 11. Alcohol abuse or drug addiction. 12. Patients with a history of psychiatric disorders, oppositional personality traits, poor motivation, paranoia, or other emotional or intellectual issues that may affect informed consent validity. 13. Vaccination within one week before treatment initiation or during the dose-escalation phase. 14. Patients deemed unsuitable for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
Nasal VAS scores;

Secondary

MeasureTime frame
CSMS scores;Mini-RQLQ scores;sIgE;tIgE;

Countries

China

Contacts

Public ContactJing Ye

The First Affiliated Hospital of Nanchang University

yjholly@qq.com+86 139 7916 1109

Outcome results

None listed

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