Radiofrequency Ablation of Bilateral Inferior Turbinate Followed by Subcutaneous Immunotherapy Trial

NANot yet recruitingINTERVENTIONAL
Enrollment

392

Participants

Timeline

Start Date

October 1, 2022

Primary Completion Date

June 30, 2026

Study Completion Date

December 31, 2026

Conditions
Allergic Rhinitis Due to House Dust Mite
Interventions
PROCEDURE

Radiofrequency ablation of bilateral inferior turbinate followed by subcutaneous immunotherapy

The regulation and monitoring of the entire soft-coagulation process are conducted via the radiofrequency generator under endoscopic guidance. Lateral out-fracture of the inferior turbinate is performed if necessary. One month after surgery, allergen immunotherapy will be conducted. Standardized Dp allergen extracts (Alutard SQ, ALK-Abell'o) were used for SCIT. According to the manufacturer's instructions, the build up phase was carried out with weekly injections of volumes of 0.2, 0.4, and 0.8 mL in the first 3 vials (nos. 1 to 3) and 0.1, 0.2, 0.4, 0.8, and 1.0 mL in vial no. 4, reaching the maintenance dose, 100,000 standardized quality units. The specialist adjusted the dose according to the patient's therapeutic response, and the cumulative allergen dose for each patient was the maximal tolerable injected dose. Then, the maintenance dose was given with an injection interval of 6±2 weeks according to the manufacturer's recommendations.

PROCEDURE

SCIT

Allergen immunotherapy will be conducted. Standardized Dp allergen extracts (Alutard SQ, ALK-Abell'o) were used for SCIT. According to the manufacturer's instructions, the build up phase was carried out with weekly injections of volumes of 0.2, 0.4, and 0.8 mL in the first 3 vials (nos. 1 to 3) and 0.1, 0.2, 0.4, 0.8, and 1.0 mL in vial no. 4, reaching the maintenance dose, 100,000 standardized quality units. The specialist adjusted the dose according to the patient's therapeutic response, and the cumulative allergen dose for each patient was the maximal tolerable injected dose. Then, the maintenance dose was given with an injection interval of 6±2 weeks according to the manufacturer's recommendations.

All Listed Sponsors
lead

Eye & ENT Hospital of Fudan University

OTHER

NCT05510024 - Radiofrequency Ablation of Bilateral Inferior Turbinate Followed by Subcutaneous Immunotherapy Trial | Biotech Hunter | Biotech Hunter