Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201602001487159 Date of Approval: 23/02/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Study of serum interleukin 17 level in children with bronchial asthma
Official scientific title Study of serum interleukin 17 level in children with bronchial asthma
Brief summary describing the background and objectives of the trial Asthma is an inflammatory disease and is considered the most common chronic disease affecting children. In asthmatic airways, IL-17 serum level correlates with the incidence of airway hyper-responsiveness and the severity of the disease. Aim of this study was to find if there is significant increase in IL-17 serum level in asthmatic children and to study the correlation between expression of IL-17 and both of expression of total IgE and the severity of the disease.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Paediatrics,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/01/2015
Actual trial start date 01/01/2015
Anticipated date of last follow up 30/06/2015
Actual Last follow-up date 30/06/2015
Anticipated target sample size (number of participants) 85
Actual target sample size (number of participants) 85
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group asthmatic group 0 1 day 5 ml bl collected 50
Control Group control 0 1 day 5 ml bl collected 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Every Asthmatic child had at least three attacks of (paroxysmal dyspnea, cough, and wheeze). Attack was relived spontaneously or with treatment (mainly with beta 2 agonist). Patients had to be completely symptoms free for at least 2 weeks in between attacks. Asthmatic children had to fulfill the criteria of asthmatic diagnosis of GINA guidelines (2014) [6]. Any patient had been used systemic corticosteroid in order not to affect Interleukin 17 serum level. Patients were diagnosed with any of Asthma differential diagnoses diseases Patients were known as a carrier of a blood transmitted infectious disease or had suffered from conditions in which phlebotomy was contraindicated. 4 Year(s) 14 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/11/2013 Banha university
Ethics Committee Address
Street address City Postal code Country
Fareed Nada banha 13315 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome There was a highly significant difference in serum levels of IL-17 and total IgE in asthmatic than in control groups in children. 1-7-2015
Secondary Outcome There was also insignificant positive correlation between IL-17and IgE 1-7-2015
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
pediatric clinic of banha university hospital Fareed Nada banha 13315 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Pesronal el-mohandeseen banha 13315 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor mohammed sami bazzari el-mohandeseen st banha Egypt Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Eman Ali Nasr cairo Egypt
Dalia Hasib Fareed Nada banha Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohammed bazzari msbazzari@gmail.com 01005033347
City Postal code Country Position/Affiliation
banha Egypt
Role Name Email Phone Street address
Public Enquiries mohammed bazzari msbazzari@gmail.com 01005033347
City Postal code Country Position/Affiliation
banha Egypt
Role Name Email Phone Street address
Scientific Enquiries mohammed bazzari msbazzari@gmail.com 01005033347
City Postal code Country Position/Affiliation
banha Egypt
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information