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A prospective controlled study of the safety and efficacy of rush immunotherapy for allergic rhinitis with house dust mite allergy

A prospective controlled study of the safety and efficacy of rush immunotherapy for allergic rhinitis with house dust mite allergy

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061409
Enrollment
Unknown
Registered
2022-06-23
Start date
2022-06-10
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

allergic rhinitis

Interventions

4-day rush immunotherapy group:The dose accumulation period was shortened to 4 days
6-day rush immunotherapy group:The dose accumulation period was shortened to 6 days
cluster immunotherapy group:The dosage accumulation period was long

Sponsors

First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Typical symptoms and signs of perennial AR (nasal itchiness, nasal congestion, sneezing, runny nose, partially accompanied by anosmia); 2. Aged >=18 years and =2.0 (++++). The wind mass diameter > 3mm or SI (++) or above was positive. ALK, Denmark); 4. House dust mite serum specific IgE(sIgE) positive (>=0.35kU/L); 5. Perennial AR, mainly dust mite allergy, can be combined with allergen positive of other non-major factors, such as cockroaches, pollen, etc.; 6. HPV, novel coronavirus and other vaccines can be entered into the study 2 weeks after completion of vaccination; 7. Participate in this study voluntarily, sign informed consent, comply well, and cooperate with follow-up.

Exclusion criteria

Exclusion criteria: 1. Clinically using ß-blockers or ACEI drugs; 2. Severe metabolic, cardiovascular, immune, neurological, hematological, digestive, cerebrovascular or respiratory system diseases, such as medium-high risk hypertension, diabetes history > 5 years or complicated complications; 3. Patients with asthma; 4. Nasal polyps, acute and chronic suppurative sinusitis, secretory otitis media and other ENT diseases that may affect the study results or increase the treatment risk of the patients; 5. Participate in other clinical studies within 3 months; 6. Patients who have received AR specific immunotherapy in the past 3 years or used any drugs that can interfere with immune response, such as various chemotherapy drugs (alkylating agents, antimetabolic drugs, etc.), immune modulators such as antiviral drugs interferon, interleukin, etc.; 7. History of life-threatening anaphylaxis or angioedema; 8. Pregnant and lactating patients and patients who plan to have a pregnancy within 1 year; 9. History of malignancy; 10. Alcohol or drug abuse; 11. A history of mental illness, confrontational personality, bad motivation, paranoia, or other emotional or intellectual problems that may affect the informed validity of participation in the study; 12. Vaccination within one week before the start of treatment or during the dose-accumulation phase; 13. Those deemed unsuitable for inclusion by the researchers.

Design outcomes

Primary

MeasureTime frame
Visual analogue scale score;Allergic rhinitis quality of life questionnaire (RQLQ) score;Total serum IgE, dust mite specific IgE;Dust mite specific IgG4;Serum IL4, 5, 10, 13, 33 ;Skin prick test for allergens;Nasal provocation test;Nasal endoscopic examine;Adverse reactions;FeNO/FnNO;Peak expiratory flow;

Countries

China

Contacts

Public ContactYe Jing
yjholly@email.ncu.edu.cn+86 13979161109

Outcome results

None listed

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