How airway mucus affects inhaled IgG and respiratory germs in adults with bronchiectasis
Role of BARriers in IgG-Pathogen Interactions at the Mucosal Surface in Human Airways
We will test whether airway mucus in adults with non‑cystic fibrosis bronchiectasis changes how inhaled IgG works against respiratory germs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Tours Academic / other |
| Locations | 1 site (Tours, France) |
| Trial ID | NCT06670937 on ClinicalTrials.gov |
What this trial studies
This single-center interventional study will enroll about 30 adults with stable non‑CF bronchiectasis to collect induced sputum and blood samples. Laboratory analyses will examine how patient mucus and airway conditions create barriers that alter IgG-pathogen interactions at the mucosal surface. The work builds on preclinical data showing inhaled IgG can reduce airway pathogen load in animal models. Results aim to inform whether and how locally delivered IgG could be optimized for human airways.
Who should consider this trial
Good fit: Adults (≥18) with a clinical and CT-confirmed diagnosis of non‑cystic fibrosis bronchiectasis who are clinically stable, able to provide induced sputum, and not receiving systemic antibiotics are ideal candidates.
Not a fit: Patients with cystic fibrosis, primary ciliary dyskinesia, significant interstitial lung disease, resting oxygen dependence, IgG deficiency, pregnancy, or inability to produce sputum are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, the findings could guide development or optimization of inhaled IgG treatments to better reduce lung infections and inflammation in bronchiectasis patients.
How similar studies have performed: Preclinical animal studies showed inhaled IgG reduced airway pathogen load and related damage, but clinical evidence in bronchiectasis patients remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Clinical diagnosis of 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 Exclusion Criteria: * 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 NFCB 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
Where this trial is running
Tours, France
- CHRU de Tours — Tours, France, France (Recruiting)
Study contacts
- Principal investigator: Laurent PLANTIER, MD — CHRU de Tours
- Study coordinator: Laurent PLANTIER, MD, PhD
- Email: laurent.plantier@univ-tours.fr
- Phone: +33247476242
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.