Novel Dose Adjustment Schedule for Late Injection in SCIT in AR

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04929093
• Other study ID #: TR-SIT-16w
• Status: Completed
• Phase: Phase 4
• Start date: June 11, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: June 2021
• Source: Beijing Tongren Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: April 30, 2021
• Est. primary completion date: April 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 53 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Rhinitis
• Immunotherapy
• Rhinitis
• Rhinitis, Allergic

Intervention

Biological:
• Novel dose adjustment of Alutard SQ
novel dose adjustment schedule means directly reaching dose of Vial 4, 10,000 SQ
• conventional dose adjustment of Alutard SQ
conventional dose adjustment schedule means restarting from dose of Vial 1, 10 SQ
• Routine continuous cluster of Alutard SQ
Patient receiving continuous cluster SCIT for DM during the same period

Locations

Country	Name	City	State
China	Beijing Tongren Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	The change of medication score	MS was calculated as follows: 1, oral Clarityne tablet; 2, intranasal Budesonide nasal spray.	Baseline, week 26.
Secondary	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.