Diagnoses DiseaseNCT06137495
Immunoblot, Chemiluminescence and ImmunoCap Allergen Specific IgE Evaluation of in Allergic Rhinitis Patients
A study testing Sensitization to House dust mites in people with Diagnoses Disease, run by Zagazig University at 1 site in Egypt.
Trial summary
In the present study the investigators assay house dust mites (HDMs) IgE in sera of allergic rhinitis patients (AR) using immunoblotting, chemiluminescence, and ImmunoCAP assays to compare between the accuracy of both immunoblotting and chemiluminescence assays, and ImmunoCAP as gold standard. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Diagnoses Disease
- What is being tested?
- Sensitization to House dust mites
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 30 Jun 2023
- Phase
- Interventional
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient consent.
- Patient with (18-40) years age known to be allergic rhinitis.
- Patient with IgE mediated allergic rhinitis (positive total IgE).
- Patient with positive skin prick testing and monosensitized to HDM
Who cannot join
- Patient refusal
- Patients taking oral corticosteroid.
- Patients taking anti-IgE injections.
- Patients taking intranasal corticosteroid.
- Patient with non- IgE mediated allergic rhinitis.
- Patients with chronic diseases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Zagazig University Faculty of Medicine
Zagazig, Sharqia Province, 44519
About this study
Official title: Immunoblot and Chemiluminescence Assays Versus ImmunoCap: Evaluation of Allergen Specific IgE in Egyptian House Dust Mites Allergic Rhinitis Patients
In the present study the investigators assay house dust mites (HDMs) IgE in sera of allergic rhinitis patients (AR) using immunoblotting, chemiluminescence, and ImmunoCAP assays to compare between the accuracy of both immunoblotting and chemiluminescence assays, and ImmunoCAP as gold standard.
Read the detailed description
All allergic rhinitits patients who were monosensitized to mixed HDMs, identified by SPT, will be subjected to complete history taking and assessment of the inclusion and exclusion criteria, performance of skin prick test and measurement of total serum IgE, measurement of specific IgE by Chemiluminescence Immunoassa, immunoblot assay and ImmunoCAP™ Phadiatop™. The patients will be followed-up for 6 months.
- Conditions
- Diagnoses Disease
- Being tested
- Sensitization to House dust mites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensitization to House dust mitesDiagnostic test
Also called Allergen skin prick testing (SPT), Measurement of serum specific IgE
The SPT is performed at the time of diagnosis and after six-months follow-up period. Serum specific IgE is measured by immunoblotting, chemiluminescence, and ImmunoCAP assays
| Study group | Role | What they receive |
|---|---|---|
| Allergic Rhinitis Patients | Experimental | House dust mites (HDMs) IgE in sera of allergic rhinitis patients (AR) who were monosensitized to mixed HDMs, identified by SPT, is assayed using immunoblotting, chemiluminescence, and ImmunoCAP assays to compare between the accuracy of both immunoblotting and chemiluminescence assays, and ImmunoCAP as gold standard Receives: Diagnostic Test: Sensitization to House dust mites |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of serum specific IgE
Improvement of symptoms and signs of allergy
Measured: 6 months from diagnosis to end of Follow-up period
Conversion of SPT to negative
Improvement of symptoms and signs of allergy
Measured: 6 months from diagnosis to end of Follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Dec 2020
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnoses DiseaseStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Noha M Hammad, MD, Zagazig University
- Investigators
- Noha M Hammad, MD, Principal investigator, Faculty of Medicine, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137495
- Sponsor's protocol ID
- 6489-8-11-2020
- Status last verified
- Nov 2023
- First submitted
- 13 Nov 2023
- Last updated
- 22 Nov 2023
- 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 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunoblot and Chemiluminescence Assays Versus ImmunoCap: Evaluation of Allergen Specific IgE in Egyptian House Dust Mites Allergic Rhinitis Patients
- ClinicalTrials.gov ID
- NCT06137495
- Acronym / sponsor ID
- 6489-8-11-2020
- Conditions
- Diagnoses Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 18 Nov 2023 (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.
In the present study the investigators assay house dust mites (HDMs) IgE in sera of allergic rhinitis patients (AR) using immunoblotting, chemiluminescence, and ImmunoCAP assays to compare between the accuracy of both immunoblotting and chemiluminescence assays, and ImmunoCAP as gold standard.
Detailed description
All allergic rhinitits patients who were monosensitized to mixed HDMs, identified by SPT, will be subjected to complete history taking and assessment of the inclusion and exclusion criteria, performance of skin prick test and measurement of total serum IgE, measurement of specific IgE by Chemiluminescence Immunoassa, immunoblot assay and ImmunoCAP™ Phadiatop™. The patients will be followed-up for 6 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allergic Rhinitis Patients | Experimental | Diagnostic Test: Sensitization to House dust mitesHouse dust mites (HDMs) IgE in sera of allergic rhinitis patients (AR) who were monosensitized to mixed HDMs, identified by SPT, is assayed using immunoblotting, chemiluminescence, and ImmunoCAP assays to compare between the accuracy of both immunoblotting and chemiluminescence assays, and ImmunoCAP as gold standard |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient consent.
- Patient with (18-40) years age known to be allergic rhinitis.
- Patient with IgE mediated allergic rhinitis (positive total IgE).
- Patient with positive skin prick testing and monosensitized to HDM
Key exclusion criteria (6 listed)
- Patient refusal
- Patients taking oral corticosteroid.
- Patients taking anti-IgE injections.
- Patients taking intranasal corticosteroid.
- Patient with non- IgE mediated allergic rhinitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensitization to House dust mitesAlso: Allergen skin prick testing (SPT), Measurement of serum specific IgEThe SPT is performed at the time of diagnosis and after six-months follow-up period. Serum specific IgE is measured by immunoblotting, chemiluminescence, and ImmunoCAP assays | Diagnostic test | Allergic Rhinitis Patients |
Primary outcome
Reduction of serum specific IgE
Time frame: 6 months from diagnosis to end of Follow-up period
Improvement of symptoms and signs of allergy
Conversion of SPT to negative
Time frame: 6 months from diagnosis to end of Follow-up period
Improvement of symptoms and signs of allergy
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 22 Nov 2023.
- 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.
Noha M Hammad, MD principal investigator
Faculty of Medicine, Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensitization to House dust mites in people with Diagnoses Disease, run by Zagazig University at 1 site in Egypt.
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 4 inclusion and 6 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 22 Nov 2023. 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 Egypt. 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?
Reduction of serum specific IgE (time frame: 6 months from diagnosis to end of Follow-up period). The study lists 2 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 22 Nov 2023.