Skip to content

Study on the efficacy and biomarker of AIT with Chinese rhinitis and asthma children

Study on the efficacy and biomarker of AIT with Chinese rhinitis and asthma children

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071876
Enrollment
Unknown
Registered
2023-05-26
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

Allergic rhinitis and allergic asthma

Interventions

AIT Treatment Group:AIT treatment with Alutard SQ for 3 years

Sponsors

The Third Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 18 Years

Inclusion criteria

Inclusion criteria: ? Age: over 5 years old, less than 15 years old; ? Children who met the diagnostic criteria of allergic rhinitis, bronchial asthma, and allergic rhinitis combined with asthma in Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis 2015 [16] and Chinese Guidelines for the diagnosis and treatment of Allergic Asthma [17]; ? Confirmed presence of dust mite allergen positive: dermatophagoides pteronyssinus skin prick test showed house dust mite ++ or above; Or the allergen test showed grade 2 or above house dust mite specific IgE; ? no recent severe asthma attack or other serious allergic diseases. ? Parents or guardians agreed to AIT treatment and signed written informed consent.

Exclusion criteria

Exclusion criteria: ?severe or uncontrolled asthma [forced expiratory volume in 1 second (FEV1) < 70% predicted]; ?patients who could not control their symptoms or whose lung function continued to decrease with the use of grade 4 or 5 asthma control regimens; ? two consecutive episodes of unexplained anaphylaxis during immunotherapy; ? patients receiving ß-blockers, angiotensin-converting enzyme inhibitors (ACEI) or monoamine oxidase inhibitors; ? patients with serious cardiovascular and cerebrovascular diseases, immune diseases (including autoimmune diseases and immunodeficiency diseases), malignant diseases and chronic infectious diseases; ? patients with severe psychological illness, poor compliance, or inability to understand the risks and limitations of treatment. ? patients who had received previous allergen specific immunotherapy ? poor patient compliance or other conditions considered by the investigator to be inappropriate for participating in the study.

Design outcomes

Primary

MeasureTime frame
Serum Der p, Der p 1, and Der p 2 specific IgE;Serum and saliva Der p, Der p 1, and Der p 2 specific IgG4;Serum and saliva Der p 1, and Der p 2 specific IgG1;Serum Der p specific IgE blocking factor ;Symptom & VAS score;RQLQ ;

Countries

China

Contacts

Public ContactChen Zhuanggui

Third Affiliated Hospital of Sun Yat-sen University

1014203273@qq.com+86 136 0000 9221

Outcome results

None listed

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