Bronchial AsthmaNCT06459895
Biochemical Role of Long Non-coding RNA MALAT 1 and Serum Tumor Necrosis Factor Alpha in Bronchial Asthma Patients.
An observational study of Bronchial Asthma, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- Long non-coding MALAT1 gene expression assay:
- How many people
- 194 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Apr 2024to 10 Jun 2024
- How long will I take part?
- 2 Months
- 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 15 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- All patients were admitted to Sohag University Hospital, chest department DIAGNOSED AS BRONCHIAL ASTHMA
Who cannot join
- Patients with malignancies, major trauma or surgery, and acute or chronic infectious diseases were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Bronchial Asthma
- Being tested
- Long non-coding MALAT1 gene expression assay:
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long non-coding MALAT1 gene expression assay:Diagnostic test
RNA extraction (isolation from whole blood) II-Synthesis of CDNA from RNA by reverse transcription III-Gene expression assay by RT-PCR reaction
| Study group | Role | What they receive |
|---|---|---|
| diseased group | bronchial asthma diseased group Receives: Diagnostic Test: Long non-coding MALAT1 gene expression assay: | |
| control group | healthy person Receives: Diagnostic Test: Long non-coding MALAT1 gene expression assay: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long non-coding MALAT1 gene expression assay:
Gene expression assay by RT-PCR reaction
Measured: 2 MONTHS
Secondary outcomes (1)
TNF-alpha
measured in serum by ELISA
Measured: 2 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start16 Apr 2024
- Primary completion10 Jun 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 194 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zainab Mahmoud Kadry, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459895
- Sponsor's protocol ID
- Soh-Med-24-05-03PD
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22765163Levy 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.
PubMed 26306100Lee 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.
PubMed 15378055
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biochemical Role of Long Non-coding RNA MALAT 1 and Serum Tumor Necrosis Factor Alpha in Bronchial Asthma Patients.
- ClinicalTrials.gov ID
- NCT06459895
- Acronym / sponsor ID
- Soh-Med-24-05-03PD
- Conditions
- Bronchial Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 14 Jun 2024 (actual)
- 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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diseased group | – | Diagnostic Test: Long non-coding MALAT1 gene expression assay:bronchial asthma diseased group |
| control group | – | Diagnostic Test: Long non-coding MALAT1 gene expression assay:healthy person |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (1 listed)
- All patients were admitted to Sohag University Hospital, chest department DIAGNOSED AS BRONCHIAL ASTHMA
Key exclusion criteria (1 listed)
- Patients with malignancies, major trauma or surgery, and acute or chronic infectious diseases were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long non-coding MALAT1 gene expression assay:RNA extraction (isolation from whole blood) II-Synthesis of CDNA from RNA by reverse transcription III-Gene expression assay by RT-PCR reaction | Diagnostic test | control group, diseased group |
Primary outcome
Long non-coding MALAT1 gene expression assay:
Time frame: 2 MONTHS
Gene expression assay by RT-PCR reaction
1 secondary outcome
TNF-alpha
Time frame: 2 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 14 Jun 2024.
- Background: PubMed 22765163Choi 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.
- Background: PubMed 26306100Levy 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.
- Background: PubMed 15378055Lee 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bronchial Asthma, run by Sohag 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 1 inclusion and 1 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 14 Jun 2024. 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?
Long non-coding MALAT1 gene expression assay: (time frame: 2 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 NCT06459895, which also lists 3 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 14 Jun 2024.