A Phase 3 interventional study of sublingual immunotherapy in Allergic Rhinitis, sponsored by Zagazig University. Status unknown. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2021-04-21.
Sponsored by Zagazig University · Phase 3, Interventional, and Treatment
Better management and improving outcome of children with allergic rhinitis
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.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's planned enrollment of 30 is below the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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.
Exclusion Criteria:
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 .
Drug: sublingual immunotherapy
sublingual immunotherapy is the only disease modifying therapy preventing the evolution of AR to asthma
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
Time frame: baseline
No study locations are listed for this record.
Plan to share: No
This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Zagazig University