Bronchial AsthmaNCT04175093
Some Biomarkers in Bronchial Asthma in Children
An observational study of Bronchial Asthma, run by Assiut University.
Trial summary
Asthma, a disease characterized by chronic airway inflammation and hyper -responsiveness, is a common disease that affects all age groups. Asthma may be manifested as irreversible airflow obstruction in some patients. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- asymmetric dimethylarginine
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 29 Nov 2019to 21 Nov 2021
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: All the children included in the study will be exposed to full clinical examination and history for assessment of severity of asthma in patient groups according to the guidelines for diagnosis and managemt of asthma 2007.
Who may be able to join
None listed.
Who cannot join
- Obese children,
- The presence of chronic heart, liver and kidney diseases, concomitant chronic inflammatory disease and autoimmune disorders, and Diabetes mellitus.
- Patients taking antioxidant drugs, vitamins, diuretics, hormone replacement therapy will be also excluded.
- Children aged less than six years. 5-children who have symptoms of lower or upper respiratory tract infection or asthma exacerbation within the previous four weeks.
About this study
Official title: A Study on Some Biomarkers in Bronchial Asthma in Children
Asthma, a disease characterized by chronic airway inflammation and hyper -responsiveness, is a common disease that affects all age groups. Asthma may be manifested as irreversible airflow obstruction in some patients. Although the pathogenesis of asthma is not well understood, increased oxidative stress due to an imbalance of oxidants and antioxidants has been found to be associated with asthma. In asthma, inflammation-related oxidative stress is driven by exposure to a variety of triggers, including allergens and viruses, which activate components of both the innate and acquired immune responses. Protection by escaping from triggering factors or standardization of asthma medication is difficult and usually is not enough for effective treatment. On the other hand, correction of antioxidative systems may be more efficacious in the control of asthmatic inflammation and asthma symptoms.
Little is known about the role of asymmetric dimethylarginine in the pathogenesis of asthmatic airway inflammation. The lung is a major source of asymmetric dimethylarginine that can promote oxidative stress by a reduction in nitric oxide synthesis which would result in higher levels of peroxynitrite, that causes oxidative cell damage, and exacerbate airway inflammation. asymmetric dimethylarginine can modify lung function, increase airway hyper-reactivity even in non-inflamed airways, and promote lung collagen production and deposition. Increased asymmetric dimethylarginine in serum has been found to be associated with the severity of symptoms of asthma in obese adults.
Malondialdehyde is an oxidant marker of pulmonary oxidative stress, and lipid peroxidation. Paraoxonase, an antioxidant enzyme may play a protective role in asthma. It hydrolyzes lipid peroxides and prevents low-density lipoprotein oxidation.
- Conditions
- Bronchial Asthma
- Being tested
- asymmetric dimethylarginine
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
asymmetric dimethylarginineDiagnostic test
measurement by ELISA of asymmetric dimethylarginine
| Study group | Role | What they receive |
|---|---|---|
| Mild persistent asthma | • Group I, patients with mild persistent asthma. Receives: Diagnostic Test: asymmetric dimethylarginine | |
| Moderate persistent asthma | • Group II, patients with moderate persistent asthma. Receives: Diagnostic Test: asymmetric dimethylarginine | |
| Severe persistent asthma | • Group III ,patients with severe persistent asthma. Receives: Diagnostic Test: asymmetric dimethylarginine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of asymmetric dimethylarginine in the study groups
measurement from serum samples by competitive ELISA with a standard range from 0.1 to 5.0 μmol/L.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start29 Nov 2019 (estimated)
- Primary completion21 Nov 2020 (estimated)
- Study completion21 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- More trials run by Assiut 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Safwat Abd-Elaleem Hafez, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175093
- Sponsor's protocol ID
- BRASTHMA
- Status last verified
- Nov 2019
- First submitted
- 20 Nov 2019
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Some Biomarkers in Bronchial Asthma in Children
- ClinicalTrials.gov ID
- NCT04175093
- Acronym / sponsor ID
- BRASTHMA
- Conditions
- Bronchial Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 29 Nov 2019 (estimated)
- Primary completion
- 21 Nov 2020 (estimated)
- Study completion
- 21 Nov 2021 (estimated)
- First posted
- 22 Nov 2019 (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.
Asthma, a disease characterized by chronic airway inflammation and hyper -responsiveness, is a common disease that affects all age groups. Asthma may be manifested as irreversible airflow obstruction in some patients. Although the pathogenesis of asthma is not well understood, increased oxidative stress due to an imbalance of oxidants and antioxidants has been found to be associated with asthma. In asthma, inflammation-related oxidative stress is driven by exposure to a variety of triggers, including allergens and viruses, which activate components of both the innate and acquired immune responses. Protection by escaping from triggering factors or standardization of asthma medication is difficult and usually is not enough for effective treatment. On the other hand, correction of antioxidative systems may be more efficacious in the control of asthmatic inflammation and asthma symptoms.
Little is known about the role of asymmetric dimethylarginine in the pathogenesis of asthmatic airway inflammation. The lung is a major source of asymmetric dimethylarginine that can promote oxidative stress by a reduction in nitric oxide synthesis which would result in higher levels of peroxynitrite, that causes oxidative cell damage, and exacerbate airway inflammation. asymmetric dimethylarginine can modify lung function, increase airway hyper-reactivity even in non-inflamed airways, and promote lung collagen production and deposition. Increased asymmetric dimethylarginine in serum has been found to be associated with the severity of symptoms of asthma in obese adults.
Malondialdehyde is an oxidant marker of pulmonary oxidative stress, and lipid peroxidation. Paraoxonase, an antioxidant enzyme may play a protective role in asthma. It hydrolyzes lipid peroxides and prevents low-density lipoprotein oxidation.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild persistent asthma | – | Diagnostic Test: asymmetric dimethylarginine• Group I, patients with mild persistent asthma. |
| Moderate persistent asthma | – | Diagnostic Test: asymmetric dimethylarginine• Group II, patients with moderate persistent asthma. |
| Severe persistent asthma | – | Diagnostic Test: asymmetric dimethylarginine• Group III ,patients with severe persistent asthma. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All the children included in the study will be exposed to full clinical examination and history for assessment of severity of asthma in patient groups according to the guidelines for diagnosis and managemt of asthma 2007.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Obese children,
- The presence of chronic heart, liver and kidney diseases, concomitant chronic inflammatory disease and autoimmune disorders, and Diabetes mellitus.
- Patients taking antioxidant drugs, vitamins, diuretics, hormone replacement therapy will be also excluded.
- Children aged less than six years. 5-children who have symptoms of lower or upper respiratory tract infection or asthma exacerbation within the previous four weeks.
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 |
|---|---|---|
| asymmetric dimethylargininemeasurement by ELISA of asymmetric dimethylarginine | Diagnostic test | Mild persistent asthma, Moderate persistent asthma, Severe persistent asthma |
Primary outcome
The percentage of asymmetric dimethylarginine in the study groups
Time frame: 24 hours
measurement from serum samples by competitive ELISA with a standard range from 0.1 to 5.0 μmol/L.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchial Asthma, run by Assiut University.
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 0 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: status not confirmed, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
The percentage of asymmetric dimethylarginine in the study groups (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2019.