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Trial design for a safety and efficacy evaluation of an accelerated up-dosing scheme using one strength for allergen immunotherapy with semi-depot house dust mite allergen extract in children with asthma in China.

Trial design for a safety and efficacy evaluation of an accelerated up-dosing scheme using one strength for allergen immunotherapy with semi-depot house dust mite allergen extract in children with asthma in China.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100575
Enrollment
Unknown
Registered
2025-04-11
Start date
2025-04-17
Completion date
Unknown
Last updated
2025-04-14

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

Conditions

Asthma

Interventions

Accelerated group:An accelerated dose increase was performed with NHD
Conventional group:Use NHD 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) Age 5-14 years old; (2) IgE mediated mild to moderate allergic asthma with or without allergic rhinitis caused by dust mite allergens (house dust mites and or dust mites) : a. Children with mild to moderate allergic asthma and well-controlled levels (refer to the diagnostic criteria of the Standardized Diagnosis and Treatment Recommendations for Bronchial Asthma in Children 2020 Edition); b. Skin prick test for house dust mite and or dust mite wind mass>=++ (skin index =0.5) or house dust mite and or dust mite sIgE>=0.7 kU/L;

Exclusion criteria

Exclusion criteria: 1. In the judgment of the investigator, the subject and/or parent/legal guardian are unable to understand and comply with the requirements of the study; 2. Patients with severe or uncontrolled asthma (FEV1 <70% predicted value) and irreversible airflow obstruction; 3. Patients on beta-blockers or Angiotensin-converting enzyme (ACE) inhibitors; 4. Severe autoimmune diseases, including AIDS, inflammatory bowel disease and other immune deficiency diseases and autoimmune diseases, severe psychological disorders,cancer. 5.Poor compliance

Design outcomes

Primary

MeasureTime frame
Adverse events;

Secondary

MeasureTime frame
Tolerability;Changes in laboratory test values (hematology, clinical chemistry, and urinalysis);Lung function;ACT/C-ACT;Visual analogue scale score, VAS;

Countries

China

Contacts

Public ContactJun Bai

Foshan Women and Children Hospita

junjun2125@126.com+86 180 3883 0338

Outcome results

None listed

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