Metabolomic profiling of blood and urine in teens with asthma
Metabolomics in the Diagnosis and Treatment of Asthma in Children
This project will test whether specific blood and urine metabolites can identify asthma flare-ups in teenagers aged 12–17.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Sponsor | I.M. Sechenov First Moscow State Medical University Academic / other |
| Locations | 1 site (Moscow) |
| Trial ID | NCT07280364 on ClinicalTrials.gov |
What this trial studies
This observational study will enroll about 100 children aged 12–17 with a confirmed diagnosis of bronchial asthma and group them by disease severity and by whether they are having an exacerbation. A separate subgroup receiving targeted therapy will also be included, and all participants will be hospitalized in the pulmonology department for sample collection. Blood and urine samples will be taken at admission for all patients and again around day 10 for those experiencing an exacerbation, alongside spirometry measurements and the Asthma Control Test. Participants will receive their usual physician-prescribed asthma treatments throughout the study while samples are analyzed by metabolomic methods to look for metabolite patterns linked to exacerbations.
Who should consider this trial
Good fit: Ideal candidates are adolescents 12–17 years old with a confirmed diagnosis of asthma who can give informed consent and be hospitalized at the study center, without severe concomitant somatic, metabolic, or endocrine diseases.
Not a fit: Children younger than 12, those without a confirmed asthma diagnosis, patients with serious comorbid conditions, or those unable/unwilling to be hospitalized are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could help clinicians detect or predict asthma exacerbations and guide more personalized treatment for adolescents.
How similar studies have performed: Prior metabolomics studies in asthma have shown promising metabolite signals related to severity and exacerbations but results remain exploratory and not yet widely validated for clinical use.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Moscow
- I.M. Sechenov First Moscow State Medical University (Sechenov University) — Moscow, Russia (Recruiting)
Study contacts
- Principal investigator: Natalia A. Geppe, MD, Doctor of M.Sc., Professor — I.M. Sechenov First Moscow State Medical University
- Study coordinator: Natalia A. Geppe, MD, Doctor of M.Sc, Professor
- Email: geppe@mail.ru
- Phone: +7-499-248-44-22
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.