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A multicenter, randomized, open clinical study to evaluate the safety of a single concentration accelerated dose escalation regimen using semi-depot house dust mite allergen extract in the treatment of moderate-to-severe allergic rhinoconjunctivitis in Chinese children with or without asthma

A multicenter, randomized, open clinical study to evaluate the safety of a single concentration accelerated dose escalation regimen using semi-depot house dust mite allergen extract in the treatment of moderate-to-severe allergic rhinoconjunctivitis in Chinese children with or without asthma

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050311
Enrollment
Unknown
Registered
2021-08-26
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-04-25

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

Conditions

allergic rhinitis

Interventions

Accelerated group:An accelerated dose increase was performed with Alog (dimite allergen preparation, house dust mite/dust mite: 50/50%)
Conventional group:Use Alog (dimite allergen preparation, house dust mite/dust mite: 50/50%) for regular dose escalation as per product instructions

Sponsors

Foshan Women and Children Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1.Signed informed consent; 2.Aged 5 to 14 years; 3.IgE-mediated moderate to severe allergic rhinitis or rhinoconjunctivitis (with or without allergic asthma) caused by house dust mite allergens; 4.Patients with allergic asthma must be classified as "well controlled" under GINA 2020.

Exclusion criteria

Exclusion criteria: 1.General criteria such as inability to understand and comply with research requirements, low expected compliance, mental retardation, etc.; 2.Immunotherapy criteria include previous AIT injection for anaphylactic shock and dust mite specific immunotherapy in recent 5 years, etc.; 3.Diseases and health status: such as Severe acute or chronic diseases, Autoimmune diseases, immune defects, Severe psychiatric and psychological disorders, etc.; 4.Medications: Use of ß-blockers (locally or systemically), ACE inhibitors, contraindication for use of adrenalin, etc.

Design outcomes

Primary

MeasureTime frame
Total adverse events/serious adverse events and the number, incidence, timing, type and intensity of adverse events/serious adverse events related to semi-depot house dust mite allergen extract;

Secondary

MeasureTime frame
Changes in laboratory test values (hematology, clinical chemistry, and urinalysis) before and after treatment;Change of vital signs and lung function measured before and after the treatment phase;Tolerability;Asthma Control Score;

Countries

China

Contacts

Public ContactBai Jun

Foshan Women and Children Hospital

junjun2125@126.com+86 18038830338

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026