Metabolomics in the Diagnosis and Treatment of Asthma in Children

January 27, 2026 updated by: I.M. Sechenov First Moscow State Medical University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Natalia A. Geppe, MD, Doctor of M.Sc, Professor
  • Phone Number: +7-499-248-44-22
  • Email: geppe@mail.ru

Study Contact Backup

Study Locations

  • Russia
      • Moscow, Russia
        • Recruiting
        • I.M. Sechenov First Moscow State Medical University (Sechenov University)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study will include children hospitalized in the pulmonology department of the Sechenov Center for Maternity and Childhood Care at Sechenov University.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and 10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I.M. Sechenov First Moscow State Medical University

Investigators

  • Principal Investigator: Natalia A. Geppe, MD, Doctor of M.Sc., Professor, I.M. Sechenov First Moscow State Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

December 1, 2025

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Actual)

December 12, 2025

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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