Novel Dose Adjustment Schedule for Late Injection in SCIT in AR

Beijing Tongren Hospital102 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

102

Conditions

Allergic Rhinitis Immunotherapy

Interventions

Novel dose adjustment of Alutard SQBIOLOGICAL

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

conventional dose adjustment of Alutard SQBIOLOGICAL

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

Routine continuous cluster of Alutard SQBIOLOGICAL

Patient receiving continuous cluster SCIT for DM during the same period

Eligibility

Sex: ALLMin age: 5 YearsMax age: 53 Years

Medical Language ↔ Plain English

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.

Locations (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: baseline, week 3, week 6, week 26.

Secondary Outcomes

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).

Time frame: 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.

Time frame: 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

Time frame: week 26.

Data from ClinicalTrials.gov

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