NCT04929093

Novel Dose Adjustment Schedule for Late Injection in SCIT in AR

Comparative Study of Novel and Conventional Dose Adjustment Schedules for Late Injection of More Than 16 Weeks in Subcutaneous Immunotherapy in Allergic Rhinitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Beijing Tongren Hospital · Academic / Other
• Sex: All
• Age: 5 Years – 53 Years
• Healthy volunteers: Not accepted

Summary

Allergen specific immunotherapy is currently the only curative intervention for allergic rhinitis (AR). Subcutaneous immunotherapy (SCIT) need to be reinstituted with an interruption of more than 16 weeks in maintenance period, leading to increased time and economic cost burden and difficulties for continuing further treatment for patients. The aim of present study was to develop a novel dose adjustment schedule for such situation and to compare the clinical efficacy and adverse reactions between novel and conventional schedules for dust mite (DM) SCIT of AR subjects.

Conditions

• Allergic Rhinitis
• Immunotherapy

Interventions

Type	Name	Description
BIOLOGICAL	Novel dose adjustment of Alutard SQ	novel dose adjustment schedule means directly reaching dose of Vial 4, 10,000 SQ
BIOLOGICAL	conventional dose adjustment of Alutard SQ	conventional dose adjustment schedule means restarting from dose of Vial 1, 10 SQ
BIOLOGICAL	Routine continuous cluster of Alutard SQ	Patient receiving continuous cluster SCIT for DM during the same period

Timeline

• Start date: 2020-06-11
• Primary completion: 2021-04-16
• Completion: 2021-04-30
• First posted: 2021-06-18
• Last updated: 2021-06-18

Locations

1 site across 1 country: China