Biochemical Role of Long Non-coding RNA MALAT 1 and Serum Tumor Necrosis Factor Alpha in Bronchial Asthma Patients.
June 10, 2024 updated by: Zainab Mahmoud Kadry, Sohag University
Bronchial asthma affects more than a quarter of a billion people worldwide. It is responsible for over 1000 deaths a day, of which the majority are preventable (Levy, 2015).
Asthma is a common heterogeneous disease characterized by chronic airway inflammation. It is defined by the history of variable respiratory symptoms, such as shortness of breath, chest tightness, wheezes, and cough, together with variable expiratory airflow limitation. Airflow limitation may later become persistent (GINA, 2023).
The diagnosis of asthma is based on the history of these characteristic symptoms and evidence of variable expiratory airflow limitation from bronchodilator reversibility testing or other tests (GINA, 2023).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
194
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Sohag, Egypt
- Sohag University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
The study was case control had included 97 asthma patients and 97 healthy controls.
The asthmatic patients will cautiously select from those attending the respiratory consultant clinics at Sohag University Hospital diagnosed with asthma (with no history of respiratory infections) PFT was performed with a spirometer (PHILIPS).
The primary purpose of it was to confirm the diagnosis of asthma.
Pre- and post-bronchodilator spirometer measurements will be performed in all study subjects and forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) values and FEV1/FVC ratio will be
Description
Inclusion Criteria:
- All patients were admitted to Sohag University Hospital, chest department DIAGNOSED AS BRONCHIAL ASTHMA
Exclusion Criteria:
- Patients with malignancies, major trauma or surgery, and acute or chronic infectious diseases were excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
diseased group
bronchial asthma diseased group
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RNA extraction (isolation from whole blood) II-Synthesis of CDNA from RNA by reverse transcription III-Gene expression assay by RT-PCR reaction
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control group
healthy person
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RNA extraction (isolation from whole blood) II-Synthesis of CDNA from RNA by reverse transcription III-Gene expression assay by RT-PCR reaction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Long non-coding MALAT1 gene expression assay:
Time Frame: 2 MONTHS
|
Gene expression assay by RT-PCR reaction
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2 MONTHS
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TNF-alpha
Time Frame: 2 MONTHS
|
measured in serum by ELISA
|
2 MONTHS
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Levy ML. The national review of asthma deaths: what did we learn and what needs to change? Breathe (Sheff). 2015 Mar;11(1):14-24. doi: 10.1183/20734735.008914.
- Choi JP, Kim YS, Kim OY, Kim YM, Jeon SG, Roh TY, Park JS, Gho YS, Kim YK. TNF-alpha is a key mediator in the development of Th2 cell response to inhaled allergens induced by a viral PAMP double-stranded RNA. Allergy. 2012 Sep;67(9):1138-48. doi: 10.1111/j.1398-9995.2012.02871.x. Epub 2012 Jul 5.
- Lee CG, Link H, Baluk P, Homer RJ, Chapoval S, Bhandari V, Kang MJ, Cohn L, Kim YK, McDonald DM, Elias JA. Vascular endothelial growth factor (VEGF) induces remodeling and enhances TH2-mediated sensitization and inflammation in the lung. Nat Med. 2004 Oct;10(10):1095-103. doi: 10.1038/nm1105. Epub 2004 Sep 19.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 16, 2024
Primary Completion (Actual)
June 10, 2024
Study Completion (Actual)
June 10, 2024
Study Registration Dates
First Submitted
June 10, 2024
First Submitted That Met QC Criteria
June 10, 2024
First Posted (Actual)
June 14, 2024
Study Record Updates
Last Update Posted (Actual)
June 14, 2024
Last Update Submitted That Met QC Criteria
June 10, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-24-05-03PD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.