Novel Dose Adjustment Schedule for Late Injection in SCIT in AR

Capital Medical University

Status and phase: Completed; Phase 4

Conditions: Immunotherapy; Allergic Rhinitis

Treatments: Biological: conventional dose adjustment of Alutard SQ; Biological: Novel dose adjustment of Alutard SQ; Biological: Routine continuous cluster of Alutard SQ

Study type: Interventional

Funder types: Other

Identifiers

NCT04929093

TR-SIT-16w

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 5 to 53 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 3 patient groups

Novel dose adjustment schedule

Experimental group

Description:

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

Treatment:

Biological: Novel dose adjustment of Alutard SQ

Conventional dose adjustment

Active Comparator group

Description:

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

Treatment:

Biological: conventional dose adjustment of Alutard SQ

Continuous cluster SCIT schedule

Active Comparator group

Description:

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

Treatment:

Biological: Routine continuous cluster of Alutard SQ