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A study of saliva allergen specific IgG4 as a bio-marker for AIT efficacy monitoring

Saliva allergen specific IgG4 - a potential marker for allergen specific immunotherapy

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIN-16009909
Enrollment
Unknown
Registered
2016-11-18
Start date
2016-11-05
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

allergic rhinitis and/or asthma caused by HDM sensitize

Interventions

Study group:HDM Alutard AIT
Control group:Symptomatic allergy medication only

Sponsors

The Second People's Hospital of Wuhu
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Male or female aged 5-55 year; 2. Patient with mild to moderate persistent HDM allergic rhinitis (with or without asthma); 3. Positive Skin Prick Test (SPT) response (wheal index SI = 0.5) to Dermatophagoides pteronyssinus.

Exclusion criteria

Exclusion criteria: 1. PEF < 70% of predicted value; 2. Requirement of inhaled or systemic corticosteroid therapy for asthma symptoms during the screening period, with a daily dosage of beclomethasone dipropionate 800ug, or regular oral intake of prednisone; 3. Current symptoms or treatment of ongoing upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process; 4. AIT treatment with house dust mite allergens or other allergen within the last 5 years; 5. Any diagnosis of underlying disease in heart, lung, liver, kidney, or blood, etc.; 6. Patient is under treatment with ß-blocker; 7. Patient with immune defects / deficiencies, or in immunosuppressive treatment; 8. Allergy, hypersensitivity or intolerance to any of the first aid medicines; 9. Any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the trial, and/or evidence of an uncooperative attitude; 10. Unlikely to be able to complete the trial, for any reason, or likely to move, or travel for extended periods of time during the trial period; 11. Subjects shouldn't meets any of the exclusion criteria listed.

Design outcomes

Primary

MeasureTime frame
Rhinitis symptoms;Asthma symptoms;Medications on AR;Medications on asthma;Juniper's RQLQ;Juniper's AQLQ;Der p, Der p 1, Der p 2 specific IgE in serum;Der p, Der p 1, Der p 2 specific IgG4 in serum;Der p, Der p 1, Der p 2 specific IgG4 in saliva;

Countries

China

Contacts

Public ContactXiaozhong Gui

The Second People's Hospital of Wuhu

guixiaozhong@yeah.net+86 15309636868

Outcome results

None listed

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