Novel Dose Adjustment Schedule for Late Injection in SCIT in AR

Study Overview
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Brief Summary
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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.

Official Title
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Comparative Study of Novel and Conventional Dose Adjustment Schedules for Late Injection of More Than 16 Weeks in Subcutaneous Immunotherapy in Allergic Rhinitis

Conditions
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Allergic Rhinitis, Immunotherapy

Intervention / Treatment
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* Biological: Novel dose adjustment of Alutard SQ
* Biological: conventional dose adjustment of Alutard SQ
* Biological: Routine continuous cluster of Alutard SQ


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 53 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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. |