Bronchiectasis
Conditions
Keywords
Bronchiectasis, Immunity
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.
Interventions
DEVICECyranose® 320
Detection of patterns of specific Volatile Organic Compounds in exhaled air
Sponsors
Sociedad Española de Neumología y Cirugía Torácica
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 6 months | Baseline and 6 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in patterns of specific volatile organic compounds in exhaled air at 3 months | Baseline and 3 months | The patterns of specific volatile organic compounds in exhaled air will be determined with the electronic nose device (Cyranose® 320). |
| Change from baseline in patterns of specific volatile organic compounds in exhaled air at 6 months | Baseline and 6 months | The patterns of specific volatile organic compounds in exhaled air will be determined with the electronic nose device (Cyranose® 320). |
| Change from baseline in patterns of specific volatile organic compounds in exhaled air at 9 months | Baseline and 9 months | The patterns of specific volatile organic compounds in exhaled air will be determined with the electronic nose device (Cyranose® 320). |
| Change from baseline in patterns of specific volatile organic compounds in exhaled air at 12 months | Baseline and 12 months | The patterns of specific volatile organic compounds in exhaled air will be determined with the electronic nose device (Cyranose® 320). |
Countries
Spain
Contacts
Primary ContactOriol Sibila, MD PhD
Outcome results
None listed