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Impaired Secretory IgA and Mucosal Immunity in Cystic Fibrosis

NCT02308267 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2016-02-25

No results posted yet for this study

Summary

This project entitled "Impaired secretory IgA and mucosal immunity in cystic fibrosis" is a research program which aims to determine, owing to national (KULeuven) and international (Descartes university Paris, university of Torino) collaborations for expertise and access to human material, whether a defect exists for the production of IgA antibodies in the lung from patients with this serious genetic disease. These antibodies line and protect normally the airways, and are secreted through a specific epithelial receptor called pIgR (polymeric immunoglobulin receptor); its expression and regulation will be studied in lung tissue and in cell cultures of the lung epithelium from these patients. The link between the putative IgA defect and chronic bacterial infection with Pseudomonas aeruginosa, which often complicates the evolution of the disease, will also be evaluated ex vivo and in vivo, in an animal model of lung infection.

Conditions

Interventions

OTHER

Lung explants

Lung explants from end-stage CF, which were obtained for a reason independent from the study in the Paris (Prof Burgel) and Leuven (Prof Dupont) centres will be analysed for pIgR and IgA expression as well as for Pseudomonas aeruginosa colonization. Some lung explants from control patients will also be obtained from the Leuven centre.

OTHER

Sputum, nasal fluid and serum

Sputum, nasal (fluid) and serum samples from CF patients and controls patients will be collected (Leuven, Paris, Torino, Verona and Saint-Luc Brussels) for S-IgA and microbiological assays. Spontaneous sputum will be collected, while nasal fluid will be sampled through nasal lavage. Control subjects will consist of COPD patients and healthy subjects (smokers or not).

PROCEDURE

Bronchoscopy

Endobronchial biopsies (EBB) and broncho-alveolar lavage (BAL) will be sampled at the KULeuven centre (Prof Dupont) in some CF patients (homozygous for the DF508 mutation) and colonized or not with Pseudomonas aeruginosa and who must have a general anaesthesia for a reason independent from the study. In these patients, a bronchial endoscopy will be performed during narcosis to take EBB (n=8) and BAL (2x50mL). If possible, nasal and rectal biopsies will also be performed in some patients. Samples will be assessed for pIgR and IgA expression and for primary broncho-epithelial cultures (carried out at the UCL centre, Pr Pilette). Control subjects will be patients without CF and without evidence of lung disease and who are undergoing narcosis for an independent reason at the KULeuven centre.

Sponsors & Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    lead OTHER

Principal Investigators

  • Charles Pilette, MD, PhD · Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02308267 on ClinicalTrials.gov