Circulating Micro RNAs Expression in Egyptian Bronchial Asthma and COPD Patients

Asthma Clinical Trial

Official title:

Circulating Micro RNAs Expression in Egyptian Bronchial Asthma and COPD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02719145
• Other study ID #: TFMEC1015
• Status: Completed
• First received: March 19, 2016
• Last updated: April 23, 2018
• Start date: October 2015
• Est. completion date: September 2016

Study information

• Verified date: April 2018
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 air?ow 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.

Related Conditions & MeSH terms

• Asthma
• COPD

Locations

Country	Name	City	State
Egypt	Chest Department, Faculty of Medicine, Tanta University	Tanta	Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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): — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.