NCT06459895

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 14, 2024

Completed
Last Updated

June 14, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

June 10, 2024

Last Update Submit

June 10, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Long non-coding MALAT1 gene expression assay:

    Gene expression assay by RT-PCR reaction

    2 MONTHS

Secondary Outcomes (1)

  • TNF-alpha

    2 MONTHS

Study Arms (2)

diseased group

bronchial asthma diseased group

Diagnostic Test: Long non-coding MALAT1 gene expression assay:

control group

healthy person

Diagnostic Test: Long non-coding MALAT1 gene expression assay:

Interventions

RNA extraction (isolation from whole blood) II-Synthesis of CDNA from RNA by reverse transcription III-Gene expression assay by RT-PCR reaction

control groupdiseased group

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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

You may qualify if:

  • All patients were admitted to Sohag University Hospital, chest department DIAGNOSED AS BRONCHIAL ASTHMA

You may not qualify if:

  • Patients with malignancies, major trauma or surgery, and acute or chronic infectious diseases were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 22765163BACKGROUND
  • 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.

    PMID: 26306100BACKGROUND
  • 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.

    PMID: 15378055BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Ten ml of blood was collected from patients by venipuncture. Samples were divided into two parts. The first part was added to EDTA (Ethylenediamine-tetra acetic acid) tube, until the extraction of RNA

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD in Medical Biochemistry

Study Record Dates

First Submitted

June 10, 2024

First Posted

June 14, 2024

Study Start

April 16, 2024

Primary Completion

June 10, 2024

Study Completion

June 10, 2024

Last Updated

June 14, 2024

Record last verified: 2024-06

Locations