Effect of Sublingual Immunotherapy on Platlet factor4 Level in Children

Study Purpose

Better management and improving outcome of children with allergic rhinitis

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	6 Years - 12 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04851860
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Zagazig University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Mohammad Romeh
Principal Investigator Affiliation	Zagazig University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Allergic Rhinitis

Additional Details

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.

Arms & Interventions

Arms

Other: allergic rhintis children

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 .

Interventions

Drug: - sublingual immunotherapy

sublingual immunotherapy is the only disease modifying therapy preventing the evolution of AR to asthma

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Heba Elnaggar

hebanagar77@gmail.com

00201018038288

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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