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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04984941
Other study ID # 2012-047
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2013
Est. completion date October 1, 2014

Study information

Verified date July 2021
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date October 1, 2014
Est. primary completion date March 1, 2014
Accepts healthy volunteers No
Gender All
Age group 3 Years to 60 Years
Eligibility 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


Locations

Country Name City State
China Second Affiliated Hospital,School of Medicine,Zhejiang University Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Demographic Characteristics Describe the patient's basic information in detail, including age, gender, family history, etc 1 year
Primary Der p 1 Serum IgE Prevalence of Der p 1 Serum IgE in HDM-Allergic Patients 1 year
Primary Der p 2 Serum IgE Prevalence of Der p 2 Serum IgE in HDM-Allergic Patients 1 year
Primary Dp, Der p 1 and Der p 2 Relationship between Serum IgE Levels of Dp, Der p 1 and Der p 2 1 year
Primary 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
Primary 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
Primary the Number of Affected Organs Association of Specific IgE Titers with the Number of Affected Organs 1 year
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