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NCT Number: NCT07280364

Metabolomics in the Diagnosis and Treatment of Asthma in Children

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.

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

I.M. Sechenov First Moscow State Medical University (Sechenov University)

Moscow, Russia

Location status: Recruiting

Location contact

Irina V. Ozerskaia, MD, PhD

CONTACT

[email protected]

+7-926-387-25-12

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standart medical treatment

Drug

No intervention, patients will recieve standard medical treatment

Primary outcomes

  1. inflammation biomarkers

    Time frame: 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 outcomes

  1. metabolomic changes

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Irina V. Ozerskaia, MD, PhD

CONTACT

[email protected]

+7-926-387-25-12

Natalia A. Geppe, MD, Doctor of M.Sc, Professor

CONTACT

[email protected]

+7-499-248-44-22

Sponsors and collaborators

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 12, 2025
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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