Circulating Micro RNAs Expression in Egyptian Bronchial A... | NCT02719145

Studies
Circulating Micro RNAs Expression in Egyptian Bronchial Asthma and COPD Patients

NCT02719145

Sponsor

Tanta University

Status

Completed

Last Update Posted

Apr 25, 2018Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Asthma
COPD

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Jun 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Mar 19, 2016

First Submission Date that Met QC Criteria

Mar 24, 2016

First Posted Date

Mar 25, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2018

Last Update Posted Date

Apr 25, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This cross sectional study will be carried out on 30 subjects who will be recruited from the outpatient clinic of Chest Department, Tanta University Hospital.

They will be classified into 3 groups:

Group I: It will include 10 healthy volunteer subjects. Group II: It will include 10 asthmatic patients. Group III: It will include 10 COPD patients. miR-7, miR-20a, miR-21, miR-22, miR-145 and miR-155 will be measured in serum samples from all subjects

Detailed Description

The following will be done for all subjects:

Thorough history taking with stress on age, age at onset, duration of the disease, smoking history, therapeutic history with stress on their drugs, course of the disease, history of any previous attacks of acute severe asthma or exacerbation of COPD.
Complete physical examination.
Chest x-ray P.A view.
Complete blood picture.
Ventilatory function tests including FVC, FEVI and FEVI/FVC, PEFR and FEF25-75% using computerized spirometry apparatus.

Quantitative assessment of miRNA levels: will be used to assay miR-7, miR-20a, miR-21, miR-22, miR-145 and miR-155 in serum samples from all subjects. These miRNAs were selected based on prediction algorithms that suggested that these miRNAs were involved in the regulation of cytokines.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group (group 1)		10 healthy volunteer subjects.
Asthma group (group 2)		10 asthmatic patients.
COPD group (group 3)		10 COPD patients.

Interventions

Not provided

Measure	Description	Time Frame
miR-7, miR-20a, miR-21, miR-22, miR-145 and miR-155 in serum samples from control, asthma and COPD Egyptian subjects.		6 months.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Group 1: healthy volunteers with no history of chest troubles.
Group 2: 10 asthmatic patients with history of paroxysmal wheezing, dyspnea, chest distress, and/or coughing; with Reversible airflow limitation as will be measured by an increase in forced expiratory volume in one second (FEV1) of at least 12% and of more than 200 ml after inhalation of 200 μg salbutamol.
Group 3: 10 COPD patients who have chronic airﬂow limitation on spirometry (FEV1/FVC is less than 0.7), and the patients have irreversible airflow limitation as will be measured by an increase in (FEV1) by less than12% or less than 200 ml after inhalation of 200 μg salbutamol.

Exclusion Criteria:

Upper or lower respiratory tract infection during the month preceding the study.
Other chronic respiratory or systemic illness.
Usage of systemic steroids within 2 months prior to the study.
Inability to provide informed consent or who refused to draw off blood.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

This cross sectional study will be carried out on 30 subjects who will be recruited from the outpatient clinic of Chest Department, Tanta University Hospital.

They will be classified into 3 groups:

Group I: It will includ 10 healthy volunteer subjects. Group II: It will include 10 asthmatic patients. Group III: It will include 10 COPD patients.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adel S Bediwy, MD	Chest Department, Faculty of Medicine, Tanta University	Study Chair
Salwa A Ganna, MD	Chest Department, Faculty of Medicine, Tanta University	Principal Investigator
Said Hammad, MD	Clinical Pathology Department, Faculty of Medicine, Tanta University	Principal Investigator
Abdel-Aziz A Zidan, PHD	Director of Genomics and Proteomics Unit, Center of Excellence in Cancer Research, Tanta University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chest Department, Faculty of Medicine, Tanta University		Tanta	Gharbia Governorate	31111	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21037022	Result	Van Pottelberge GR, Mestdagh P, Bracke KR, Thas O, van Durme YM, Joos GF, Vandesompele J, Brusselle GG. MicroRNA expression in induced sputum of smokers and patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2011 Apr 1;183(7):898-906. doi: 10.1164/rccm.201002-0304OC. Epub 2010 Oct 29.
26118177	Result

ID	Term
D001249	Asthma
D029424	Pulmonary Disease, Chronic Obstructive

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases