Allergic RhinitisPhase 3NCT04851860
Effect of Sublingual Immunotherapy on Platlet factor4 Level in Children
A Phase 3 study testing sublingual immunotherapy in people with Allergic Rhinitis, run by Zagazig University.
Trial summary
Better management and improving outcome of children with allergic rhinitis Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- sublingual immunotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 12 Apr 2021to 20 Nov 2021
- Phase
- Phase 3
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. Children with moderate to severe allergic rhinitis according to Allergic Rhinitis And Its Impact On Asthma (ARIA) guidelines[9], which interfere with daily activity or sleep.
- 2. Children aged (6-12) years with clinical history of allergic rhinitis for at least one year.
- 3. Children with allergic rhinitis who failed medical treatment, desire an alternative to pharmacotherapy.
- 4. Sex : male and female.
Who cannot join
- 1. Children with chronic lung \& heart diseases as: asthma and anatomical malformation for respiratory system.
- 2. disorders: Gastro Esophageal Reflux Disease, cystic fibrosis and epilepsy. 3.Children with chronic drug use: oral or nasal corticosteroids, antiepileptic and immunosuppressive.
Trial locations and contacts
No sites are listed yet.
Eman Elbehedy contact
About this study
Better management and improving outcome of children with allergic rhinitis
Read the detailed description
The prevelance of Allergic Respiratory Diseases has been increased worldwide and affect 1of 5 persons of general population . ARDs are triggered by exposure to allergen and includes allergic rhinitis with or without conjunctivitis and bronchial asthma. ARDs are associated with decreased quality of life and increased economic burden .
Allergen-specific immunotherapy is the only disease modifying therapy preventing the evolution of AR to asthma, and its efficacy has long been known since observations by Leonard Noon in 1911. Allergen immunotherapy for AR is currently considered when showing strongly suggestive symptoms of AR which interfere with daily activities or sleep, and having evidence of IgE sensitization to ≥1 clinically relevant allergen .
The European Academy of Allergy and Clinical Immunology (EAACI) recommends treatmentof children with moderate to severe AR with Allergen Immunotherapy. It includes sublingual immunotherapy (SLIT) and subcutaneous immunotherapy (SCIT).Subcutaneous immunotherapy (SCIT) has been the gold standard, whereas sublingual immunotherapy (SLIT) has emerged as an effective and safe alternative .
Sublingual immunotherapy (SLIT) is the only treatment that regulates the immunological process during development of allergic rhinitis (AR), rather than simply treating symptoms.
Platelet activation occurs during antigen-induced airway reactions in allergic and asthmatic subjects. Raised levels of platelet-derived mediators, such as the Platelet Factor-4 (PF4), it is observed in plasma and bronchoalveolar lavage fluid of atopic individuals, and has the ability to activate eosinophils, increase expression of Fc-IgG and Fc-IgE receptors, and stimulate basophils to release histamine.
- Conditions
- Allergic Rhinitis
- Being tested
- sublingual immunotherapy
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sublingual immunotherapyDrug
sublingual immunotherapy is the only disease modifying therapy preventing the evolution of AR to asthma
| Study group | Role | What they receive |
|---|---|---|
| allergic rhintis children | Other | sublingual immunotherapy is used for allergic rhintis children by dosing Allergen immunotherapy extract as sublingual drops which were kept under the tongue for a couple of minutes and then swallowed. The sublingual drops were administered in the morning on an empty stomach . Receives: Drug: sublingual immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of serum level of platlet factor 4 before and after sublingual immunotherapy
diffrentiate serum level of platlet factor4 in children with allergic rhintis before and after treatment with sublingual immunotherapy
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start12 Apr 2021 (estimated)
- Primary completion15 Oct 2021 (estimated)
- Study completion20 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- allergic rhintis children from 6 to12 years
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Heba Mohammad Mahmoud Mahmoud Elnaggar, Zagazig University
- Investigators
- Mohammad Romeh, Study director, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851860
- Sponsor's protocol ID
- Allergic rhintis in children
- Status last verified
- Apr 2021
- First submitted
- 14 Apr 2021
- Last updated
- 21 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen Y, Zhou L, Yang Y. Effect of sublingual immunotherapy on platelet activity in children with allergic rhinitis. Braz J Otorhinolaryngol. 2017 Mar-Apr;83(2):190-194. doi: 10.1016/j.bjorl.2016.03.006. Epub 2016 Apr 22.
PubMed 27329923
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sublingual Immunotherapy on Platlet factor4 Level in Children
- ClinicalTrials.gov ID
- NCT04851860
- Acronym / sponsor ID
- Allergic rhintis in children
- Conditions
- Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 12 Apr 2021 (estimated)
- Primary completion
- 15 Oct 2021 (estimated)
- Study completion
- 20 Nov 2021 (estimated)
- First posted
- 21 Apr 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.
Better management and improving outcome of children with allergic rhinitis
Detailed description
The prevelance of Allergic Respiratory Diseases has been increased worldwide and affect 1of 5 persons of general population . ARDs are triggered by exposure to allergen and includes allergic rhinitis with or without conjunctivitis and bronchial asthma. ARDs are associated with decreased quality of life and increased economic burden .
Allergen-specific immunotherapy is the only disease modifying therapy preventing the evolution of AR to asthma, and its efficacy has long been known since observations by Leonard Noon in 1911. Allergen immunotherapy for AR is currently considered when showing strongly suggestive symptoms of AR which interfere with daily activities or sleep, and having evidence of IgE sensitization to ≥1 clinically relevant allergen .
The European Academy of Allergy and Clinical Immunology (EAACI) recommends treatmentof children with moderate to severe AR with Allergen Immunotherapy. It includes sublingual immunotherapy (SLIT) and subcutaneous immunotherapy (SCIT).Subcutaneous immunotherapy (SCIT) has been the gold standard, whereas sublingual immunotherapy (SLIT) has emerged as an effective and safe alternative .
Sublingual immunotherapy (SLIT) is the only treatment that regulates the immunological process during development of allergic rhinitis (AR), rather than simply treating symptoms.
Platelet activation occurs during antigen-induced airway reactions in allergic and asthmatic subjects. Raised levels of platelet-derived mediators, such as the Platelet Factor-4 (PF4), it is observed in plasma and bronchoalveolar lavage fluid of atopic individuals, and has the ability to activate eosinophils, increase expression of Fc-IgG and Fc-IgE receptors, and stimulate basophils to release histamine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- allergic rhintis children from 6 to12 years
| Arm | Type | Receives |
|---|---|---|
| allergic rhintis children | Other | Drug: sublingual immunotherapysublingual immunotherapy is used for allergic rhintis children by dosing Allergen immunotherapy extract as sublingual drops which were kept under the tongue for a couple of minutes and then swallowed. The sublingual drops were administered in the morning on an empty stomach . |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 1. Children with moderate to severe allergic rhinitis according to Allergic Rhinitis And Its Impact On Asthma (ARIA) guidelines[9], which interfere with daily activity or sleep.
- 2. Children aged (6-12) years with clinical history of allergic rhinitis for at least one year.
- 3. Children with allergic rhinitis who failed medical treatment, desire an alternative to pharmacotherapy.
- 4. Sex : male and female.
Key exclusion criteria (2 listed)
- 1. Children with chronic lung \& heart diseases as: asthma and anatomical malformation for respiratory system.
- 2. disorders: Gastro Esophageal Reflux Disease, cystic fibrosis and epilepsy. 3.Children with chronic drug use: oral or nasal corticosteroids, antiepileptic and immunosuppressive.
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 |
|---|---|---|
| sublingual immunotherapysublingual immunotherapy is the only disease modifying therapy preventing the evolution of AR to asthma | Drug | allergic rhintis children |
Primary outcome
measurement of serum level of platlet factor 4 before and after sublingual immunotherapy
Time frame: baseline
diffrentiate serum level of platlet factor4 in children with allergic rhintis before and after treatment with sublingual immunotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Results publication: PubMed 27329923Chen Y, Zhou L, Yang Y. Effect of sublingual immunotherapy on platelet activity in children with allergic rhinitis. Braz J Otorhinolaryngol. 2017 Mar-Apr;83(2):190-194. doi: 10.1016/j.bjorl.2016.03.006. Epub 2016 Apr 22.
- 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.
Eman Elbehedy contact
Mohammad Romeh study director
Zagazig University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sublingual immunotherapy in people with Allergic Rhinitis, run by Zagazig University.
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 2 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: status not confirmed, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heba Elnaggar (00201018038288, hebanagar77@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of serum level of platlet factor 4 before and after sublingual immunotherapy (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04851860, which also lists 1 linked publication.
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 21 Apr 2021.