Asthma
Conditions
Keywords
bronchial asthma, children, metabolomics, metabolites
Brief summary
The goal of this observational study is to learn about the metabolomic profile of blood and urine in children 12-17 years with asthma. The main question it aims to answer is: • Are there metabolites in the blood and urine that are specific for asthma exacerbation? Participants already receive standard therapy as part of their regular medical care for asthma.
Detailed description
The study plans to enroll 100 children with a confirmed diagnosis of bronchial asthma of varying severity. Patients will be divided into groups based on disease severity (mild and severe/moderate) and stage (exacerbation/non-exacerbation). A separate group of patients receiving targeted therapy will also be included. All patients will be hospitalized in the pulmonology department. Blood and urine samples will be collected for metabolomic analysis upon admission. Patients not experiencing an exacerbation will not be re-evaluated. For patients experiencing an asthma exacerbation, blood and urine samples will be collected again after 10 days. Throughout the study, patients will receive the usual therapy prescribed by their treating physician. Treatment for exacerbations includes inhaled budesonide and ipratropium bromide/fenoterol via a nebulizer; systemic steroids may be used if indicated. All patients will undergo spirometry upon admission to the department. Patients in the acute stage will undergo spirometry at least twice, including on the 10th day, plus or minus 2 days. All patients complete the Asthma Control Test questionnaire upon admission.
Interventions
No intervention, patients will recieve standard medical treatment
Sponsors
I.M. Sechenov First Moscow State Medical University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Age from 12 to 17 years old * Confirmed diagnosis of asthma * Informed voluntary consent to participate in the study
Exclusion criteria
* age under 12 years * no established diagnosis of asthma * concomitant severe somatic, metabolic, and endocrine diseases * patient's withdrawal of informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| inflammation biomarkers | baseline and 10 days | Identification of metabolomic changes (inflammation biomarkers) in the blood (aminoacids) and urine (organic acids) of patients with mild, moderate, and severe bronchial asthma associated with asthma exacerbation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| metabolomic changes | baseline and 10 days | Changes in the metabolomic profile of blood and urine depending on the severity of asthma and the therapy being administered: compare the urine metabolomic profile for organic acids and aminoacids in blood in children with mild and modereate/severe asthma. Assess the dynamics of blood and urine metabolomic profiles in children with severe asthma before and after therapy with biologic agents.Identify the relationship between the blood and urine metabolomic profile in children with asthma and respiratory function parameters. |
Countries
Russia
Contacts
CONTACTNatalia A. Geppe, MD, Doctor of M.Sc, Professor
CONTACTIrina V. Ozerskaia, MD, PhD
PRINCIPAL_INVESTIGATORNatalia A. Geppe, MD, Doctor of M.Sc., Professor
I.M. Sechenov First Moscow State Medical University
Outcome results
None listed