AsthmaNCT02719145
Circulating Micro RNAs Expression in Egyptian Bronchial Asthma and COPD Patients
An observational study of Asthma and COPD, run by Tanta University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2015to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Chest Department, Faculty of Medicine, Tanta University
Tanta, Gharbia Governorate, 31111
About this study
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
Read the 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.
- Keywords
- micro RNA, asthma, COPD
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control group (group 1) | 10 healthy volunteer subjects. | |
| Asthma group (group 2) | 10 asthmatic patients. | |
| COPD group (group 3) | 10 COPD patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
miR-7, miR-20a, miR-21, miR-22, miR-145 and miR-155 in serum samples from control, asthma and COPD Egyptian subjects.
Measured: 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startOct 2015
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adel Salah Bediwy, Tanta University
- Investigators
- Adel S Bediwy, MD, Study chair, Chest Department, Faculty of Medicine, Tanta UniversitySalwa A Ganna, MD, Principal investigator, Chest Department, Faculty of Medicine, Tanta UniversitySaid Hammad, MD, Principal investigator, Clinical Pathology Department, Faculty of Medicine, Tanta UniversityAbdel-Aziz A Zidan, PHD, Principal investigator, Director of Genomics and Proteomics Unit, Center of Excellence in Cancer Research, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719145
- Sponsor's protocol ID
- TFMEC1015
- Status last verified
- Apr 2018
- First submitted
- 19 Mar 2016
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 21037022Wang 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.
PubMed 26118177
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Micro RNAs Expression in Egyptian Bronchial Asthma and COPD Patients
- ClinicalTrials.gov ID
- NCT02719145
- Acronym / sponsor ID
- TFMEC1015
- Keywords
- micro RNA, asthma, COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group (group 1) | – | –10 healthy volunteer subjects. |
| Asthma group (group 2) | – | –10 asthmatic patients. |
| COPD group (group 3) | – | –10 COPD patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
miR-7, miR-20a, miR-21, miR-22, miR-145 and miR-155 in serum samples from control, asthma and COPD Egyptian subjects.
Time frame: 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2018.
- Results publication: PubMed 21037022Van 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.
- Results publication: PubMed 26118177Wang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adel S Bediwy, MD study chair
Chest Department, Faculty of Medicine, Tanta University
Salwa A Ganna, MD principal investigator
Chest Department, Faculty of Medicine, Tanta University
Said Hammad, MD principal investigator
Clinical Pathology Department, Faculty of Medicine, Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and COPD, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
miR-7, miR-20a, miR-21, miR-22, miR-145 and miR-155 in serum samples from control, asthma and COPD Egyptian subjects. (time frame: 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02719145, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2018.