Effect of Sublingual Immunotherapy on Platlet factor4 Level in Children

NCT04851860 | Unknown Phase 3

• 1 other identifier: Allergic rhintis in children
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Better management and improving outcome of children with allergic rhinitis

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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

  baseline

Study Arms (1)

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 .

Drug: sublingual immunotherapy

Interventions

sublingual immunotherapy DRUG

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

allergic rhintis children

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. 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.
• \. Children aged (6-12) years with clinical history of allergic rhinitis for at least one year.
• \. Children with allergic rhinitis who failed medical treatment, desire an alternative to pharmacotherapy.
• \. Sex : male and female.

You may not qualify if:

• \- 1. Children with chronic lung \& heart diseases as: asthma and anatomical malformation for respiratory system.
• \. disorders: Gastro Esophageal Reflux Disease, cystic fibrosis and epilepsy. 3.Children with chronic drug use: oral or nasal corticosteroids, antiepileptic and immunosuppressive.

Sponsors & Collaborators

• Zagazig University: lead

Related Publications (1)

• 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.

  PMID: 27329923 RESULT

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Sublingual Immunotherapy

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Desensitization, Immunologic; Immunosuppression Therapy; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Mohammad Romeh

  Zagazig University

  STUDY DIRECTOR

Central Study Contacts

Heba Elnaggar

CONTACT

00201018038288; hebanagar77@gmail.com

Eman Elbehedy

CONTACT

00201098177980

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor Heba

Model Details: allergic rhintis children from 6 to12 years

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 21, 2021
• Study Start: April 12, 2021
• Primary Completion: October 15, 2021
• Study Completion: November 20, 2021
• Last Updated: April 21, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share