Role of Innate Immunity in Non-Cystic Fibrosis Bronchiectasis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Bronchial Infections in Patients With Non-Cystic Fibrosis (CF) Bronchiectasis; Role of Innate Lung Defense Mechanisms and Utility of an Electronic Nose for Its Diagnosis

Conditions
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Bronchiectasis

Intervention / Treatment
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* Device: Cyranose® 320


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-CF Bronchiectasis<br>Cyranose® 320 | Device: Cyranose® 320<br>* Detection of patterns of specific Volatile Organic Compounds in exhaled air<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in sputum mucin levels at 12 months | Mucin levels in sputum will be determined with ELISA kits | Baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in sputum mucin levels at 3 months | Mucin levels in sputum will be determined with ELISA kits | Baseline and 3 months | 
| Change from baseline in sputum mucin levels at 6 months | Mucin levels in sputum will be determined with ELISA kits | Baseline and 6 months | 
| Change from baseline in sputum mucin levels at 9 months | Mucin levels in sputum will be determined with ELISA kits | Baseline and 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchiectasis, Immunity