Role of Innate Immunity in Non-Cystic Fibrosis Bronchiectasis

• Conditions: Bronchiectasis
• Interventions: Device: Cyranose® 320

• Registration Number: NCT02163642
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

The purpose of this study is to demonstrate that 1) the secretion of mucins, antimicrobial peptides and Toll-like receptors is altered in certain patients with non-CF bronchiectasis, which makes them more susceptible to be infected by potentially pathogenic bacteria (PPB); and 2) the electronic nose is able to detect patterns of specific Volatile Organic Compounds (VOC) for patients with non-CF bronchiectasis colonized by PPB.

Detailed Description

Prospective, observational study, which will include 50 patients with non-CF bronchiectasis who will be followed for a period of 12 months. A follow up control will be performed every three months to all patients, consisting in medical record, lung function tests, blood and serum collection, sputum analysis and culture, and collection of exhaled air for analysis using an electronic nose. These tests will also be repeated whenever the patient has an exacerbation. At the beginning and end of the study, a high resolution chest CT will be performed.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-05-19
• Study First Submitted QC: 2014-06-11
• Study First Posted: 2014-06-13
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-07
• Last Update Posted: 2016-09-08
• Primary Completion: 2018-04
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Diagnosis of non- CF bronchiectasis based on at least 1 lobe with bronchial dilatation and compatible clinical symptoms such as cough, sputum production and respiratory infections.
• Signed informed consent.

Exclusion Criteria

• Presence of exacerbation in the last 4 weeks.
• Antibiotic treatment in the last 4 weeks
• Use of oral corticosteroids in the last 4 weeks
• Concomitant terminal illness.
• Current cigarette smoking
• Active allergic bronchopulmonary aspergillosis
• Diagnosis of tuberculosis or active non-tuberculous Mycobacterial infection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-CF Bronchiectasis	Cyranose® 320	Cyranose® 320

Primary Outcome Measures

Name	Time	Method
Change from baseline in sputum mucin levels at 12 months	Baseline and 12 months	Mucin levels in sputum will be determined with ELISA kits

Secondary Outcome Measures

Name	Time	Method
Change from baseline in sputum mucin levels at 6 months	Baseline and 6 months	Mucin levels in sputum will be determined with ELISA kits
Change from baseline in sputum mucin levels at 3 months	Baseline and 3 months	Mucin levels in sputum will be determined with ELISA kits
Change from baseline in sputum mucin levels at 9 months	Baseline and 9 months	Mucin levels in sputum will be determined with ELISA kits

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain