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Completed

NCT Number: NCT04929093

Novel Dose Adjustment Schedule for Late Injection in SCIT in AR

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.

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunotherapy Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

5 year–53 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Novel dose adjustment of Alutard SQ

Biological

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

conventional dose adjustment of Alutard SQ

Biological

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

Routine continuous cluster of Alutard SQ

Biological

Patient receiving continuous cluster SCIT for DM during the same period

Primary outcomes

  1. The change of Combined Symptom and Medication Score

    Time frame: 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 outcomes

  1. The change of total nasal symptom scores

    Time frame: 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).

  2. The change of medication score

    Time frame: Baseline, week 26.

    MS was calculated as follows: 1, oral Clarityne tablet; 2, intranasal Budesonide nasal spray.

  3. Adverse reactions

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 18, 2021
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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