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Dynamics of the Upper and Lower Airway Respiratory Microbiomes Associated With Severe Infant Asthma

Nature of potential dysbiosis, interrelation of the different microbiomes of the respiratory tract, and potential role of the immune system in the pathogenesis of severe asthma in infants, and its evolution under treatment. Exploring and understanding these data is to improve patient care and discover new therapeutic targets. The aim is to open up prospects for therapeutic studies, such as the use of azithromycin as an immunomodulator in infant asthma, the results of which are discordant.

ClinicalTrials.gov IDNCT06044051

PhaseNA

Enrollment100

SponsorUniversity Hospital, Rouen

AgeNo minimum reported

SexALL

I'm interested View official listing

Conditions studied

Asthma in Children, Asthma

About this study

Interventions

Other: Blood sample — An additionnal volume of blood will be collected at inclusion and at each follow-up visit
Other: Expectoration — Expectoration will be collected at inclusion and at each follow-up visit
Other: Nasopharyngeal swab — A nasopharyngeal swab will be collected at inclusion and at each follow-up visit after an induced sputum

Primary outcomes

description of microbiomes from bronchoalveolar fluids (Inclusion)
description of microbiomes from nasopharyngeal samples (Inclusion)
description of microbiomes from sputum samples (Inclusion)
description of microbiomes from bronchoalveolar fluids (at 3 months)
description of microbiomes from nasopharyngeal samples (at 3 months)
description of microbiomes from sputum samples (at 3 months)
description of microbiomes from bronchoalveolar fluids (at 6 months)
description of microbiomes from nasopharyngeal samples (at 6 months)

Eligibility information

Inclusion Criteria: * Infants less than 24 months old * Follow-up by a pneumo-pediatrician for severe asthma in infants * Requiring etiological investigations and assessment of severity in day hospitalization, including bronchial fibroscopy (HAS 2009) * Parent informed of the research and having signed consent Exclusion Criteria: * Prematurity \<32 WA * Congenital heart disease with significant left to right shunt * Chronic respiratory disease other than infant asthma (cystic fibrosis, bronchiolitis obliterans) * Antibiotic therapy in progress or administered the seven days preceding the date of inclusion (day hospitalization) * Refusal of bronchial fibroscopy

Study locations

Rouen University Hospital, Rouen, France

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.