Intratonsillar Immunotherapy for Allergic Rhinitis

NCT06523478 | Recruiting

• 2 other identifiers: WDRY2024-K0972021-1-X-2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, open-label, positive parallel controlled, blinded endpoint clinical study designed to compare the safety and efficacy of "Intratonsillar Immunotherapy of Standardized Dust Mite Allergen Extracts (Novo Helisen-Depot, Allergopharma, Merck, Germany)" with Subcutaneous Immunotherapy in patients with "Dust Mite Allergic Rhinitis." Participants will be evaluated for safety and efficacy throughout the entire three-year period.

Conditions

Allergic Rhinitis

Keywords

Allergic rhinitis; Intratonsillar; Allergen immunotherapy; Standardized dust mite allergen extracts

Outcome Measures

Primary Outcomes (2)

• Combined Symptom and Medication Score (CSMS)

  Combined Symptom and Medication Score (CSMS) serves as the primary efficacy endpoint, tracking changes in participant symptoms and assessing the sustainability and stability of treatment effects. It comprises: Allergen-induced symptom score: Scored from 0 (no symptoms) to 3 (most severe symptoms) for nasal congestion, rhinorrhea, nasal itching, sneezing, eye itching, and tearing, with the average yielding the symptom score (SS). Emergency medication use related to allergy symptoms: Assigned points based on antihistamine (1 point/day), nasal corticosteroid (2 points/day), and oral corticosteroid (3 points/day) usage, with the highest value determining the medication score (MS). CSMS (0-6) = SS (0-3) + MS (0-3). Recorded at baseline and 1, 2, 3, 6, 12, 24, and 36 months post-dust mite extract treatment.

  Pre-intervention screening period; 3 months, 6 months, 12 months, 24 months, 36 months after the first intervention. Up to 36 months

• Number of Participants with Local or Systemic Adverse Reactions

  Participants will be observed for 30 minutes post-injection and encouraged to report any adverse events during follow-up. Adverse reactions are classified as local reaction (LR) or systemic reaction (SR) according to the World Allergy Organization Subcutaneous Immunotherapy Response Classification System. Detailed records include occurrence time, number of injections, clinical manifestations, and management measures.

  After each treatment. Up to 36 months

Secondary Outcomes (7)

• Visual Analog Scale (VAS)

  Pre-intervention screening period; 3 months, 6 months, 12 months, 24 months, 36 months after the first intervention. Up to 36 months

• Absolute Value and Percentage of Blood Leukocytes

  Pre-intervention screening period; 3 months, 6 months, 12 months, 24 months, 36 months after the first intervention. Up to 36 months

• Concentration of Key Serum Cytokines

  Pre-intervention screening period; 3 months, 6 months, 12 months, 24 months, 36 months after the first intervention. Up to 36 months

• Concentration of Serum Immune Globulins

  Pre-intervention screening period; 3 months, 6 months, 12 months, 24 months, 36 months after the first intervention. Up to 36 months

• Proportion of Blood T Cell Differentiation

  Pre-intervention screening period; 3 months, 6 months, 12 months, 24 months, 36 months after the first intervention. Up to 36 months

Study Arms (2)

Intratonsillar Immunotherapy (ITIT) group

EXPERIMENTAL

The intervention of ITIT will be a series of 3 injections of a commercially-available standardized dust mite allergen extracts (Novo Helisen-Depot, Allergopharma, Merck, Germany) given every four weeks into tonsil through guidance using a 1-mL hypodermic syringe with a 25-gauge or smaller needle. The specific doses are 5 TU (0.1 ml, the first injection), 50 TU (0.1 ml, the second injection), and 50 TU (0.1 ml, the third injection). Before each injection, patients will take one tablet of antihistamine.

Procedure: Intratonsillar immunotherapy (ITIT)

Subcutaneous Immunotherapy (SCIT) group

ACTIVE COMPARATOR

The same drugs will be used in active comparator. SCIT consists of two stages: the accumulation stage and the maintenance stage. During the initial 14 weeks, patients will receive sequential subcutaneous injections as follows: (1) 1st vial: 0.1 mL, 0.2 mL, 0.4 mL, and 0.8 mL; (2) 2nd vial: 0.1 mL, 0.2 mL, 0.4 mL, and 0.8 mL; (3) 3rd vial: 0.1 mL, 0.2 mL, 0.4 mL, 0.6 mL, 0.8 mL, and 1.0 mL of allergen, achieving a maintenance dose of 5000 TU. Subsequently, maintenance therapy involves subcutaneous injections of 5000 TU (1.0 mL, 3rd vial) every 4-6 weeks. The intervention process before and after each injection is similar to that of the ITIT group.

Procedure: Subcutaneous immunotherapy (SCIT)

Interventions

Intratonsillar immunotherapy (ITIT) PROCEDURE

During injection, the operator needs to gently shake the injection bottle about 20 times, the drug must be mixed to ensure the consistency of allergen concentration, and carefully check the patient's name and concentration on the bottle. Allergy extracts should not be injected intravenously, so the syringe will be aspirated to avoid inadvertent intravascular injection. Before each injection, after inserting the needle into the selected tonsil, before injecting the dose, the investigator will slightly pull the plunger of the syringe. If blood returns from the syringe, the syringe, and its contents will be discarded. The other tonsil will be selected and a new syringe will be prepared.

Intratonsillar Immunotherapy (ITIT) group

Subcutaneous immunotherapy (SCIT) PROCEDURE

Injection requires shaking bottle 20x to mix drug for consistency. Verify patient name \& concentration. Use 1 ml skin test syringe for deep subcutaneous injection at 45° angle, 1 cm into outer upper arm. Lift skin folds for deeper injection, avoid subcutaneous, muscular or intravascular. Inject slowly, 1 min for 1 ml. Avoid shallow injections which may cause local side effects. Alternate between left \& right arm for 5 min after injection for compression.

Subcutaneous Immunotherapy (SCIT) group

Eligibility Criteria

• Age: 5 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign informed consent.
• Commitment to follow the research procedures and cooperate with the implementation of the entire research process.
• Diagnosis in accordance with ARIA guidelines, based on:
• ① Symptoms: Two or more symptoms such as paroxysmal sneezing, watery nose, nasal itching, and nasal congestion, with symptoms lasting or accumulating for more than 1 hour per day. May be accompanied by eye symptoms such as tearing, eye itching, and eye redness.
• ② Signs: Common nasal mucosa pale, edema, nasal watery secretions.
• Allergen test: Positive for skin prick test (SPT) and/or serum-specific IgE for at least one allergen, or positive for nasal provocation test.
• Have a history of allergic rhinitis caused by atopic allergens and one of the following:
• ① No significant relief after drug treatment.
• ② Do not want to continue taking medication for a long time.
• ③ Long-term drug treatment can produce adverse side effects.
• Allergens cannot be effectively avoided in daily life.
• Women of childbearing age must ensure that they do not become pregnant during the treatment cycle.
• Must be between 5 and 65 years old.

You may not qualify if:

• Allergic to the excipient (aluminum hydroxide) of Allergopharma or the rescue medication epinephrine.
• Respiratory disease other than stable asthma.
• Pulmonary insufficiency (NYHA grade II and above or FEV1 \< 80%) or irreversible changes in the responding organs such as emphysema and bronchiectasis.
• Severe acute or chronic diseases (including malignant diseases), inflammation, and fever.
• Multiple sclerosis.
• Immune system diseases (autoimmune diseases, immune diseases caused by antigen and antibody complexes, immune deficiencies, etc.).
• Active tuberculosis.
• Severe mental disorder.
• Obvious cardiac insufficiency.
• A history of severe recurrent acute sinusitis (defined as two episodes per year within the past 2 years, each requiring antibiotic treatment).
• A history of chronic sinusitis, including at least two of the following symptoms (at least one of which should be nasal congestion or runny nose):
• ① Nasal congestion, runny nose, facial pressure, or pain.
• ② Having a diminished or lost sense of smell.
• ③ Endoscopic or CT examination showed signs of sinusitis.
• Severe liver and renal impairment, including but not limited to abnormal liver function (such as ALT, AST elevation more than 2 times the normal range), abnormal kidney function (such as creatinine clearance less than 60 mL/min), etc.

Sponsors & Collaborators

• Xu Yu: lead

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

RECRUITING

Related Publications (23)

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MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Yu Xu

  Renmin Hospital of Wuhan University

  STUDY CHAIR

Central Study Contacts

Yu Xu, Doctor

CONTACT

+8615927088198; xuy@whu.edu.cn

Tian Gu, Master

CONTACT

+8615515283168; gutian@whu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This experiment is a comparative study of two treatment methods, and there are obvious differences between the treatment methods of the experimental group and the control group, so it is difficult to blind the subjects, researchers and evaluators, and only the experiment design without blindness can be adopted.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Chief Physician

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 26, 2024
• Study Start: April 29, 2024
• Primary Completion (Estimated): April 29, 2028
• Study Completion (Estimated): April 29, 2028
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Two years after the completion of the trial
• Access Criteria: Upon approval of the request, access to the de-identified individual patient-level data will be provided. Before accessing the requested information, a data sharing agreement (a non-negotiable contract for data visitors) must be signed.

Locations

CN (1)