I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow, Russia
Location status: Recruiting
NCT Number: NCT07280364
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.
Interested in participating?
Request Info12 year–17 year
All sexes
Observational
Moscow, Russia
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No intervention, patients will recieve standard medical treatment
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.
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.
Contact information is provided by the study sponsor or research team.
Irina V. Ozerskaia, MD, PhD
CONTACT
Natalia A. Geppe, MD, Doctor of M.Sc, Professor
CONTACT
I.M. Sechenov First Moscow State Medical University
Other
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.
Published trials that share one or more normalized conditions with this study.
NCT00341237
Asthma, Bronchial Diseases
Chapel Hill, North Carolina, United States
View Trial DetailsNCT07219173
Asthma, Bronchial Diseases
Tempe, Arizona, United States
View Trial DetailsNCT07228052
Asthma, Bronchial Diseases
The Bronx, New York, United States
View Trial DetailsNCT07556159
Asthma, Bronchial Diseases
Chandler, Arizona, United States
View Trial Details