NCT07280364

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started Mar 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Mar 2024Aug 2026

Study Start

First participant enrolled

March 13, 2024

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 12, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

January 28, 2026

Status Verified

November 1, 2025

Enrollment Period

2.2 years

First QC Date

December 1, 2025

Last Update Submit

January 27, 2026

Conditions

Keywords

bronchial asthmachildrenmetabolomicsmetabolites

Outcome Measures

Primary Outcomes (1)

  • inflammation biomarkers

    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 Outcomes (1)

  • metabolomic changes

    baseline and 10 days

Interventions

No intervention, patients will recieve standard medical treatment

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • Age from 12 to 17 years old
  • Confirmed diagnosis of asthma
  • Informed voluntary consent to participate in the study

You may not qualify if:

  • age under 12 years
  • no established diagnosis of asthma
  • concomitant severe somatic, metabolic, and endocrine diseases
  • patient's withdrawal of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

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

    I.M. Sechenov First Moscow State Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

Irina V. Ozerskaia, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2025

First Posted

December 12, 2025

Study Start

March 13, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

January 28, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations