Clinical trial NCT06459895: Biochemical Role of Long Non-coding RNA MALAT 1 and Serum Tumor Necrosis Factor Alpha in Bronchial Asthma Patients.
Official title: Biochemical Role of Long Non-coding RNA MALAT 1 and Serum Tumor Necrosis Factor Alpha in Bronchial Asthma Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchial Asthma
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 194
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Long non-coding MALAT1 gene expression assay:
timeFrame: 2 MONTHS
Secondary outcomes:
measure: TNF-alpha
timeFrame: 2 MONTHS
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.