CompletedPhase 4

Novel Dose Adjustment Schedule for Late Injection in SCIT in AR

China102 participantsStarted 2020-06-11

Plain-language 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.

Who can participate

Age range5 Years – 53 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

The change of Combined Symptom and Medication Score

Timeframe: baseline, week 3, week 6, week 26.

Trial details

NCT IDNCT04929093

SponsorBeijing Tongren Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-04-16