Actively Recruiting
Role of BARriers in IgG-Pathogen Interactions at the Mucosal Surface in Human Airways
Led by University Hospital, Tours · Updated on 2025-12-10
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying non-cystic fibrosis bronchiectasis (NCFB), a chronic lung condition characterized by irreversible airway widening, obstruction, persistent cough, and mucus production. This study evaluates how mucus from NCFB patients affects the behavior of inhaled polyclonal immunoglobulin G (IgG), a potential new treatment aimed at reducing airway infections and inflammation. The investigation focuses on IgG's ability to bind pathogens like Pseudomonas aeruginosa and its movement and stability in airway mucus. The study will involve 30 patients with stable NCFB who will provide sputum samples after inhaling a saline aerosol and a blood sample. The sputum will be analyzed to identify bacteria, viruses, and fungi present and used for laboratory tests assessing IgG binding to pathogens, IgG breakdown, and mobility within mucus. These analyses will compare patient mucus with artificial mucus and evaluate the impact of microbial colonization. Participants will continue their usual medical care during the study. Each participant will attend one study visit for clinical examination, medical history review, lung function assessment, and quality of life questionnaires. Blood and induced sputum samples will be collected for microbiological, immunological, and inflammatory analysis. The main outcome measured is how well IgG binds to Pseudomonas aeruginosa in patient mucus using whole-cell ELISA. Secondary outcomes include IgG breakdown and mobility, as well as the influence of airway microbes. No follow-up visits are planned, and the study will last from enrollment up to three months for outcome assessment.
CONDITIONS
Brief Title
Role of BARriers in IgG-Pathogen Interactions at the Mucosal Surface in Human Airways
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 2 18 years
- Clinical diagnosis of non-cystic fibrosis bronchiectasis (NCFB)
- Computed tomography (CT) evidence of bilateral bronchiectasis
- Consent for research use of data and material
- Ability to provide an induced sputum sample
- Stable clinical status over the last 4 weeks
You will not qualify if you...
- Pulmonary disease other than NCFB (except asthma)
- Diagnosis of cystic fibrosis
- Diagnosis of primary ciliary dyskinesia
- Requirement for oxygen therapy at rest
- Diagnosis of IgG deficiency (total serum IgG < 5.4 g/l)
- Treatment with a CFTR modulator drug in the last 6 months
- Unilateral bronchectasis
- CT evidence of interstitial lung disease with traction bronchectasis
- Refusal of the patient
- Acute exacerbation of NCFB in the last 4 weeks
- No sputum production
- Current treatment with systemic antibiotics (other than low dose azithromycin)
- Pregnancy or breastfeeding
- Subject under legal protection (e.g., guardianship, tutorship)
- Inability to produce a sputum sample
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment and consent
Duration - 1 day
Participants attend a single visit where clinical data is collected, including medical history, clinical examination, and quality of life questionnaires. Blood samples and induced sputum samples are collected for analysis of immune and microbial parameters relevant to non-cystic fibrosis bronchiectasis.
1 visit (in-person) including blood draw and sputum induction
Trial Site Locations
Total: 1 location
1
CHRU de Tours
Tours, France, France, 37044
Actively Recruiting
Research Team
L
Laurent PLANTIER, MD, PhD
T
Thomas Secher, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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