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A Study on Switching from Sublingual to Subcutaneous Specific Immunotherapy in Patients with Dust Mite-Allergic Rhinitis (with or without Asthma)

A multicenter randomized controlled study on the efficacy of sublingual to subcutaneous specific immunotherapy in patients with dust mite-allergic rhinitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116343
Enrollment
Unknown
Registered
2026-01-08
Start date
2026-01-08
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis (with or without Asthma)

Interventions

Group 1: :SLIT for 1 year
Group 2:SLIT for the first 6 months, then SCIT for the subsequent 6 months

Sponsors

The Seventh Affiliated Hospital of Sun Yat-sen University (Shenzhen)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Aged 5–65 years (the 2022 AR guideline states that the minimum age for subcutaneous immunotherapy is 5 years). 2) IgE-mediated allergic rhinitis (with or without allergic asthma) caused by house-dust-mite allergens (Dermatophagoides pteronyssinus and/or D. farinae), classified per ARIA: positive SPT to D. pteronyssinus and/or D. farinae, and specific IgE = 0.35 kU/L to either mite. 3) If concomitant bronchial asthma is present, asthma must be diagnosed according to GINA 2020 and be well-controlled. 4) Patients who have received sublingual immunotherapy for six months with a CSMS reduction from baseline of <30 %.

Exclusion criteria

Exclusion criteria: 1) In the investigator’s judgment, the subject and/or parent/legal guardian is unable to understand or comply with study requirements. 2) Severe or uncontrolled asthma (FEV1 < 70 % predicted) or the presence of irreversible airflow obstruction. 3) Significant cardiovascular disease, or current treatment with ß-blockers or ACE inhibitors. 4) Marked nasal septal deviation, chronic rhinosinusitis with or without nasal polyps. 5) Urticaria and/or atopic dermatitis. 6) Severe autoimmune disorders, immunodeficiency (e.g., AIDS, inflammatory bowel disease), active infection, diabetes, gastric ulcer, immunocompromised status, liver cirrhosis, chronic kidney disease, or any diagnosed autoimmune condition. 7) Regular use of oral corticosteroids or other immunosuppressive agents within 3 months prior to screening.

Design outcomes

Primary

MeasureTime frame
Combined Symptom and Medication Score;—

Countries

China

Contacts

Public ContactJinxiu Zhang

The Seventh Affiliated Hospital of Sun Yat-sen University (Shenzhen)

zhangjinxiu@sysush.com+86 755 8120 6893

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026