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

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 Overview

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

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Second Affiliated Hospital，School of Medicine，Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 60 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients were evaluated by a physician face-to-face, using a detailed questionnaire to establish the nature and severity of their clinical manifestations. The questionnaire also included demographic characteristics, a family history of allergic diseases and any other history of allergic disease.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Chair: Wang Huiying, 2nd affiliated Hospital,School of Medicine,Zhejiang University,China

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2013
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): October 1, 2014

Study Registration Dates

• First Submitted: July 11, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (ACTUAL): August 2, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 2, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: China; House dust mite; Der p 1; Der p 2
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Conjunctival Diseases; Dermatitis; Rhinitis; Rhinitis, Allergic; Conjunctivitis
• Other Study ID Numbers: 2012-047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No