Novel Dose Adjustment Schedule for Late Injection in SCIT in AR

Phase 4

Completed

• Conditions: Immunotherapy; Allergic Rhinitis
• Interventions: Biological: Novel dose adjustment of Alutard SQ; Biological: Routine continuous cluster of Alutard SQ; Biological: conventional dose adjustment of Alutard SQ

• Registration Number: NCT04929093
• Lead Sponsor: Beijing Tongren Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-11
• Primary Completion: 2021-04-16
• Study Completion: 2021-04-30
• Status Verified: 2021-06
• Study First Submitted: 2021-06-08
• Study First Submitted QC: 2021-06-16
• Last Update Submitted: 2021-06-16
• Study First Posted: 2021-06-18
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Novel dose adjustment schedule	Novel dose adjustment of Alutard SQ	The patients in this group had late injections of more than 16 weeks in maintenance period, and restarted SCIT with novel dose adjustment schedule.
Continuous cluster SCIT schedule	Routine continuous cluster of Alutard SQ	The subjects had a routine cluster SCIT schedule without interrupted period.
Conventional dose adjustment	conventional dose adjustment of Alutard SQ	The patients in this group had late injections of more than 16 weeks in maintenance period, and restarted SCIT with conventional dose adjustment schedule.

Primary Outcome Measures

Name	Time	Method
The change of Combined Symptom and Medication Score	baseline, week 3, week 6, week 26.	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.

Secondary Outcome Measures

Name	Time	Method
The change of medication score	Baseline, week 26.	MS was calculated as follows: 1, oral Clarityne tablet; 2, intranasal Budesonide nasal spray.
Adverse reactions	week 26.	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
The change of total nasal symptom scores	baseline, week 3, week 6, week 26.	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).

Trial Locations

Locations (1)

Beijing Tongren Hospital; 🇨🇳 Beijing, Beijing, China