Novel Dose Adjustment Schedule for Late Injection in SCIT in AR

NCT04929093 | Completed Phase 4

• 1 other identifier: TR-SIT-16w
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The change of Combined Symptom and Medication Score

  CSMS which was calculated as follows: (total nasal symptom scores (TNSS))/4+ MS as recommended by European Academy of Allergy and Clinical Immunology (EAACI) Position Paper. The CSMS score was 0-6, 0 for good therapeutic effect and 6 for poor therapeutic effect.

  baseline, week 3, week 6, week 26.

Secondary Outcomes (3)

• The change of total nasal symptom scores

  baseline, week 3, week 6, week 26.

• The change of medication score

  Baseline, week 26.

• Adverse reactions

  week 26.

Study Arms (3)

Novel dose adjustment schedule

EXPERIMENTAL

The patients in this group had late injections of more than 16 weeks in maintenance period, and restarted SCIT with novel dose adjustment schedule.

Biological: Novel dose adjustment of Alutard SQ

Conventional dose adjustment

ACTIVE COMPARATOR

The patients in this group had late injections of more than 16 weeks in maintenance period, and restarted SCIT with conventional dose adjustment schedule.

Biological: conventional dose adjustment of Alutard SQ

Continuous cluster SCIT schedule

ACTIVE COMPARATOR

The subjects had a routine cluster SCIT schedule without interrupted period.

Biological: Routine continuous cluster of Alutard SQ

Interventions

Novel dose adjustment of Alutard SQ BIOLOGICAL

novel dose adjustment schedule means directly reaching dose of Vial 4, 10,000 SQ

Novel dose adjustment schedule

conventional dose adjustment of Alutard SQ BIOLOGICAL

conventional dose adjustment schedule means restarting from dose of Vial 1, 10 SQ

Conventional dose adjustment

Routine continuous cluster of Alutard SQ BIOLOGICAL

Patient receiving continuous cluster SCIT for DM during the same period

Continuous cluster SCIT schedule

Eligibility Criteria

• Age: 5 Years - 53 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• (1) aged 18 to 60 years;
• (2) only had a positive response to Der p and Der f but no other inhalant allergens based on EUROline Allergy Diagnostics (Beijing Oumeng Biotechnology Co., Ltd., Beijing, China). Meanwhile at least Der p -specific IgE (sIgE) in serum of was ≥ 0.7 kU/l (CAP Pharmacia, Uppsala, Sweden) using ImmunoCAP system (Pharmacia, Uppsala, Sweden) regardless of the result of Der p -specific IgE in serum;
• (3) had reached cluster SCIT maintenance period and the overall treatment time was more than 1 year but less than 2 years;
• (4) hope to continue to complete the entire treatment and have good compliance.

You may not qualify if:

• (1) diagnosed as asthma based on the guidelines of the Global Initiative for Asthma(13);
• (2) had Grade II or above systemic adverse reactions occurred in the past SCIT period.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

Location

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

• Luo Zhang

  Beijing Tongren Hospital, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 18, 2021
• Study Start: June 11, 2020
• Primary Completion: April 16, 2021
• Study Completion: April 30, 2021
• Last Updated: June 18, 2021

Record last verified: 2021-06

Locations

CN (1)