AsthmaNCT04984941
Evaluation of the Role of IgE Responses to Der p 1 and Der p 2 in Chinese House Dust Mite-Allergic Patients
An observational study of Asthma and Allergic Rhinitis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 3 to 60 years
- Conditions the study is for
- Asthma, Allergic Rhinitis, Conjunctivitis
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2013to 1 Oct 2014
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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).
Who cannot join
- Patients who refused to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital，School of Medicine，Zhejiang University
Hangzhou, Zhejiang
About this study
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.
Read the 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.
- Conditions
- Asthma, Allergic Rhinitis, Conjunctivitis, Atopic Dermatitis
- Keywords
- House dust mite, Der p 1, Der p 2, China
- Medical subject headings
- Asthma, Rhinitis, Allergic, Conjunctivitis, Dermatitis, Atopic
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic Characteristics
Describe the patient's basic information in detail, including age, gender, family history, etc
Measured: 1 year
Der p 1 Serum IgE
Prevalence of Der p 1 Serum IgE in HDM-Allergic Patients
Measured: 1 year
Der p 2 Serum IgE
Prevalence of Der p 2 Serum IgE in HDM-Allergic Patients
Measured: 1 year
Dp, Der p 1 and Der p 2
Relationship between Serum IgE Levels of Dp, Der p 1 and Der p 2
Measured: 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
Measured: 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
Measured: 1 year
the Number of Affected Organs
Association of Specific IgE Titers with the Number of Affected Organs
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start1 Mar 2013
- Primary completion1 Mar 2014
- Study completion1 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wang Huiying, Study chair, 2nd affiliated Hospital,School of Medicine,Zhejiang University,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984941
- Sponsor's protocol ID
- 2012-047
- Status last verified
- Jul 2021
- First submitted
- 11 Jul 2021
- Last updated
- 2 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of IgE Responses to Der p 1 and Der p 2 in Chinese House Dust Mite-Allergic Patients
- ClinicalTrials.gov ID
- NCT04984941
- Acronym / sponsor ID
- 2012-047
- Conditions
- Asthma, Allergic Rhinitis, Conjunctivitis, Atopic Dermatitis
- Keywords
- House dust mite, Der p 1, Der p 2, China
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 1 Mar 2014 (actual)
- Study completion
- 1 Oct 2014 (actual)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 3 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Patients who refused to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demographic Characteristics
Time frame: 1 year
Describe the patient's basic information in detail, including age, gender, family history, etc
Der p 1 Serum IgE
Time frame: 1 year
Prevalence of Der p 1 Serum IgE in HDM-Allergic Patients
Der p 2 Serum IgE
Time frame: 1 year
Prevalence of Der p 2 Serum IgE in HDM-Allergic Patients
Dp, Der p 1 and Der p 2
Time frame: 1 year
Relationship between Serum IgE Levels of Dp, Der p 1 and Der p 2
Factors associated with specific IgE against Der p 1
Time frame: 1 year
Study the patient's basic information and identify factors that are clearly associated with specific IgE against Der p 1
Factors associated with specific IgE against Der p 2
Time frame: 1 year
Study the patient's basic information and identify factors that are clearly associated with specific IgE against Der p 2
the Number of Affected Organs
Time frame: 1 year
Association of Specific IgE Titers with the Number of Affected Organs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wang Huiying study chair
2nd affiliated Hospital,School of Medicine,Zhejiang University,China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Allergic Rhinitis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic Characteristics (time frame: 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021.