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Novel Dose Adjustment Schedule for Late Injection in SCIT in AR

NCT04929093 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2021-06-18

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Beijing Tongren Hospital

    lead OTHER

Principal Investigators

  • Luo Zhang · Beijing Tongren Hospital, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
53 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-11
Primary Completion
2021-04-16
Completion
2021-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04929093 on ClinicalTrials.gov