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An open, randomized, multicenter study optimizing the safety of accelerated immunotherapy regimens in Chinese adolescents and adults with moderate to severe allergic nasal/nasal conjunctivitis with or without asthma

An open, randomized, multicenter study optimizing the safety of accelerated immunotherapy regimens in Chinese adolescents and adults with moderate to severe allergic nasal/nasal conjunctivitis with or without asthma

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060194
Enrollment
Unknown
Registered
2022-05-21
Start date
2022-05-10
Completion date
Unknown
Last updated
2024-04-29

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:optimal accelerated scheme
Standard group:standard schem

Sponsors

Xiangya Hospital Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Sign informed consent; 2. Aged 12-65 years; 3. Moderate to severe IgE mediated 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 standards such as inability to understand and comply with research requirements, low expected compliance, intellectual disability, etc.; 2. Criteria for immunotherapy such as anaphylactic shock by AIT injection in the past, dust mite specific immunotherapy in the past 5 years, etc.; 3. Diseases and health conditions: such as severe acute and chronic diseases, autoimmune diseases, immune deficiencies, severe mental and psychological disorders, etc.; 4. Medication: Use of beta-blockers (topical or systemic), ACE inhibitors, contraindications to epinephrine, etc.

Design outcomes

Primary

MeasureTime frame
adverse events;serious adverse events;the number, incidence, duration, type, and intensity of adverse events associated with injection study drugs;the number, incidence, duration, type, and intensity of serious adverse events associated with injection study drugs;

Secondary

MeasureTime frame
changes in laboratory test values before and after treatment;tolerability;

Countries

China

Contacts

Public ContactXie Zhihai

Xiangya Hospital Central South University

xiedoctor@csu.edu.cn+86 15111013198

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 12, 2026