Circulating Micro RNAs Expression in Egyptian Bronchial Asthma and COPD Patients

Completed

• Conditions: Asthma; COPD

• Registration Number: NCT02719145
• Lead Sponsor: Tanta University

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:

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-03-19
• Study First Submitted QC: 2016-03-24
• Study First Posted: 2016-03-25
• Primary Completion: 2016-06
• Study Completion: 2016-09
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-23
• Last Update Posted: 2018-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Chest Department, Faculty of Medicine, Tanta University; 🇪🇬 Tanta, Gharbia, Egypt