Evaluation of the Role of IgE Responses to Der p 1 and Der p 2 in Chinese House Dust Mite-Allergic Patients

Completed

• Conditions: Asthma; Atopic Dermatitis; Allergic Rhinitis; Conjunctivitis

• Registration Number: NCT04984941
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

One hundred patients were enrolled, based on sensitization and doctor-diagnosed allergy to HDM. Questionnaires were administered to document demographic and clinical characteristics. Serum IgE reactivity toDermatophagoides pteronyssinus (Dp) extract, Der p 1, Der p 2 and Der p 10 was measured by ImmunoCAP.

Detailed Description

Background: The role of specific IgE (sIgE) against Der p 1and Der p 2 in Chinese patients with house dust mite (HDM)allergy has not yet been well investigated.Methods: One hundred patients were enrolled, based on sensitization and doctor-diagnosed allergy to HDM. Questionnaires were administered to document demographic and clinical characteristics. Serum IgE reactivity toDermatophagoides pteronyssinus (Dp) extract, Der p 1, Der p 2 and Der p 10 was measured by ImmunoCAP.

Study Timeline

• Study Start: 2013-03-01
• Primary Completion: 2014-03-01
• Study Completion: 2014-10-01
• Status Verified: 2021-07
• Study First Submitted: 2021-07-11
• Study First Submitted QC: 2021-07-20
• Last Update Submitted: 2021-07-20
• Study First Posted: 2021-08-02
• Last Update Posted: 2021-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• HDM-allergic patients reporting allergic rhinitis, conjunctivitis, asthma and/or atopic dermatitis and who had never undergone immunotherapy, were enrolled if they were sensitized to Dp as judged by ImmunoCAP ( ≥ 1 kU/l) and/or skin reaction index (SRI)by skin-prick test (SPT, a wheal diameter ≥ 0.5 mm).

Exclusion Criteria

• Patients who refused to participate in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Der p 2 Serum IgE	1 year	Prevalence of Der p 2 Serum IgE in HDM-Allergic Patients
Demographic Characteristics	1 year	Describe the patient's basic information in detail, including age, gender, family history, etc
Factors associated with specific IgE against Der p 1	1 year	Study the patient's basic information and identify factors that are clearly associated with specific IgE against Der p 1
Der p 1 Serum IgE	1 year	Prevalence of Der p 1 Serum IgE in HDM-Allergic Patients
the Number of Affected Organs	1 year	Association of Specific IgE Titers with the Number of Affected Organs
Dp, Der p 1 and Der p 2	1 year	Relationship between Serum IgE Levels of Dp, Der p 1 and Der p 2
Factors associated with specific IgE against Der p 2	1 year	Study the patient's basic information and identify factors that are clearly associated with specific IgE against Der p 2

Trial Locations

Locations (1)

Second Affiliated Hospital，School of Medicine，Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China