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

NCT06044051 | Recruiting

• 1 other identifier: 2023/0091/HP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma in Children; Asthma

Keywords

microbiosme; Asthma in infant

Outcome Measures

Primary Outcomes (15)

• description of microbiomes from bronchoalveolar fluids

  analysis of bronchoalveolar fluids - NGS sequencing

  Inclusion

• description of microbiomes from nasopharyngeal samples

  analysis of nasopharyngeal samples- NGS sequencing

  Inclusion

• description of microbiomes from sputum samples

  analysis of sputum samples- NGS sequencing

  Inclusion

• description of microbiomes from bronchoalveolar fluids

  analysis of bronchoalveolar fluids- NGS sequencing

  at 3 months

• description of microbiomes from nasopharyngeal samples

  analysis of nasopharyngeal samples- NGS sequencing

  at 3 months

• description of microbiomes from sputum samples

  analysis of sputum samples- NGS sequencing

  at 3 months

• description of microbiomes from bronchoalveolar fluids

  analysis of bronchoalveolar fluids- NGS sequencing

  at 6 months

• description of microbiomes from nasopharyngeal samples

  analysis of nasopharyngeal samples- NGS sequencing

  at 6 months

• description of microbiomes from sputum samples

  analysis of sputum samples- NGS sequencing

  at 6 months

• description of microbiomes from bronchoalveolar fluids

  analysis of bronchoalveolar fluids - NGS sequencing

  at 9 months

• description of microbiomes from nasopharyngeal samples

  analysis of nasopharyngeal samples- NGS sequencing

  at 9 months

• description of microbiomes from sputum samples

  analysis of sputum samples- NGS sequencing

  at 9 months

• description of microbiomes from bronchoalveolar fluids

  analysis of bronchoalveolar fluids- NGS sequencing

  at 12 months

• description of microbiomes from nasopharyngeal samples

  analysis of nasopharyngeal samples- NGS sequencing

  at 12 months

• Description of microbiomes from sputum samples

  analysis of sputum samples- NGS sequencing

  at 12 months

Study Arms (1)

All patients

OTHER

All patients included will be followed for 1 year, every 3 months

Other: Blood sample; Other: Expectoration; Other: Nasopharyngeal swab

Interventions

Blood sample OTHER

An additionnal volume of blood will be collected at inclusion and at each follow-up visit

All patients

Expectoration OTHER

Expectoration will be collected at inclusion and at each follow-up visit

All patients

Nasopharyngeal swab OTHER

A nasopharyngeal swab will be collected at inclusion and at each follow-up visit after an induced sputum

All patients

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Prematurity \<32 WA
• Congenital heart disease with significant left to right shunt
• Chronic respiratory disease other than infant asthma (cystic fibrosis, bronchiolitis obliterans)
• Refusal of bronchial fibroscopy

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, France

RECRUITING

Related Publications (1)

• Petat H, Hassel C, Michel A, Charbonnier C, Plantier JC, Marguet C. Microbiosthma: a prospective study following respiratory microbiota in young children with severe preschool wheezing to better understand their respiratory future. BMC Pulm Med. 2025 Jul 16;25(1):342. doi: 10.1186/s12890-025-03812-9.

  PMID: 40670979 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• PETAT Hortense

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Mallet

CONTACT

02 32 88 82 65; secretariat.DRC@chu-rouen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: September 21, 2023
• Study Start: September 26, 2023
• Primary Completion (Estimated): September 26, 2026
• Study Completion (Estimated): September 26, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

FR (1)