Circulating Micro RNAs Expression in Egyptian Bronchial Asthma and COPD Patients

NCT ID: NCT02719145

Last Updated: 2018-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-09-30

Brief Summary

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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

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The following will be done for all subjects:

1. 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.
2. Complete physical examination.
3. Chest x-ray P.A view.
4. Complete blood picture.
5. 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.

Conditions

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Asthma COPD

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Control group (group 1)

10 healthy volunteer subjects.

No interventions assigned to this group

Asthma group (group 2)

10 asthmatic patients.

No interventions assigned to this group

COPD group (group 3)

10 COPD patients.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Adel Salah Bediwy

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adel S Bediwy, MD

Role: STUDY_CHAIR

Chest Department, Faculty of Medicine, Tanta University

Salwa A Ganna, MD

Role: PRINCIPAL_INVESTIGATOR

Chest Department, Faculty of Medicine, Tanta University

Said Hammad, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Pathology Department, Faculty of Medicine, Tanta University

Abdel-Aziz A Zidan, PHD

Role: PRINCIPAL_INVESTIGATOR

Director of Genomics and Proteomics Unit, Center of Excellence in Cancer Research, Tanta University

Locations

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Chest Department, Faculty of Medicine, Tanta University

Tanta, Gharbia Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type RESULT
PMID: 21037022 (View on PubMed)

Wang Y, Yang L, Li P, Huang H, Liu T, He H, Lin Z, Jiang Y, Ren N, Wu B, Kamp DW, Tan J, Liu G. Circulating microRNA Signatures Associated with Childhood Asthma. Clin Lab. 2015;61(5-6):467-74. doi: 10.7754/clin.lab.2014.141020.

Reference Type RESULT
PMID: 26118177 (View on PubMed)

Other Identifiers

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TFMEC1015

Identifier Type: -

Identifier Source: org_study_id

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