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

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis; Immunotherapy
• Intervention / Treatment: Biological: Novel dose adjustment of Alutard SQ; Biological: conventional dose adjustment of Alutard SQ; Biological: Routine continuous cluster of Alutard SQ

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Beijing Tongren Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 53 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• (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.

Exclusion Criteria:

• (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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Novel dose adjustment schedule; 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; novel dose adjustment schedule means directly reaching dose of Vial 4, 10,000 SQ
Active Comparator: Conventional dose adjustment; 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; conventional dose adjustment schedule means restarting from dose of Vial 1, 10 SQ
Active Comparator: Continuous cluster SCIT schedule; The subjects had a routine cluster SCIT schedule without interrupted period.	Biological: Routine continuous cluster of Alutard SQ; Patient receiving continuous cluster SCIT for DM during the same period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of total nasal symptom scores	last 7 days' overall symptom scores of major nasal symptoms (nasal obstruction, nasal itching, sneezing, and rhinorrhea: 0, no symptoms; 1, mild; 2, moderate; 3, serious). TNSS scores was 0 to 12 (0 = no symptoms;12 = most severe symptoms).	baseline, week 3, week 6, week 26.
The change of medication score	MS was calculated as follows: 1, oral Clarityne tablet; 2, intranasal Budesonide nasal spray.	Baseline, week 26.
Adverse reactions	The patients were instructed to immediately report to the physician if any symptom appeared or adverse reactions occurred during the observation period. The time and severity of onset, estimation of a possible reason, resolution, and outcome should be recorded. The adverse reactions were classified in terms of the localization (local or systemic) and the time of appearance (immediate or delayed). Local reactions (LRs) were expressed as the length of the wheal diameter. Systemic reactions (SRs) were graded in accordance with the standards of the EAACI	week 26.

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital
• Investigators: Principal Investigator: Luo Zhang, Beijing Tongren Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2020
• Primary Completion (Actual): April 16, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: June 16, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 16, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: TR-SIT-16w

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No