NCT04984941

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 2, 2021

Completed
Last Updated

August 2, 2021

Status Verified

July 1, 2021

Enrollment Period

1 year

First QC Date

July 11, 2021

Last Update Submit

July 20, 2021

Conditions

Keywords

House dust miteDer p 1Der p 2China

Outcome Measures

Primary Outcomes (7)

  • 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

Eligibility Criteria

Age3 Years - 60 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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).

You may not qualify if:

  • Patients who refused to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital,School of Medicine,Zhejiang University

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

AsthmaRhinitis, AllergicConjunctivitisDermatitis, Atopic

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRhinitisNose DiseasesOtorhinolaryngologic DiseasesConjunctival DiseasesEye DiseasesSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Study Officials

  • Wang Huiying

    2nd affiliated Hospital,School of Medicine,Zhejiang University,China

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2021

First Posted

August 2, 2021

Study Start

March 1, 2013

Primary Completion

March 1, 2014

Study Completion

October 1, 2014

Last Updated

August 2, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations