CClinicalTrials.gg
Status unknownNCT04175093Updated Nov 25, 2019

Some Biomarkers in Bronchial Asthma in Children

An observational study in Bronchial Asthma, sponsored by Assiut University. Status unknown. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2019-11-25.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Nov 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
105
Ages
3 Years to 12 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Bronchial Asthma

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03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's planned enrollment of 105 is below the median of 150 across 970 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Eligibility criteria

  • All known asthmatic patients aged six years or more who will be regularly attending Assuit University Children's Hospital Outpatient clinic.

Exclusion criteria include

  • 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.
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
105 participants (estimated)
Patient registry
No

Groups and cohorts

  • Mild persistent asthma

    • Group I, patients with mild persistent asthma.

    Diagnostic Test: asymmetric dimethylarginine

  • Moderate persistent asthma

    • Group II, patients with moderate persistent asthma.

    Diagnostic Test: asymmetric dimethylarginine

  • Severe persistent asthma

    • Group III ,patients with severe persistent asthma.

    Diagnostic Test: asymmetric dimethylarginine

Interventions

  • Diagnostic testasymmetric dimethylarginine

    measurement by ELISA of asymmetric dimethylarginine

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 hours

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04175093
Lead sponsor
Assiut University
Responsible party
Sara Safwat Abd-Elaleem Hafez (Principal investigator, Assiut University) — Principal investigator
First posted
Nov 22, 2019
Start date
Nov 29, 2019 (estimated)
Primary completion
Nov 21, 2020 (estimated)
Completion
Nov 21, 2021 (estimated)
Last update
Nov 25, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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