Brief Title
Role of Innate Immunity in Non-Cystic Fibrosis Bronchiectasis
Official Title
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
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 Type
Observational
Primary Outcome
Change from baseline in sputum mucin levels at 12 months
Secondary Outcome
Change from baseline in sputum mucin levels at 3 months
Condition
Bronchiectasis
Intervention
Cyranose® 320
Study Arms / Comparison Groups
Non-CF Bronchiectasis
Description: Cyranose® 320
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
50
Start Date
April 2014
Completion Date
April 2018
Primary Completion Date
April 2018
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Oriol Sibila, MD PhD, 0034647914193, [email protected]
Location Countries
Spain
Location Countries
Spain
Administrative Informations
NCT ID
NCT02163642
Organization ID
IIBSP-BRO-2013-154
Responsible Party
Sponsor
Study Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Sociedad Española de Neumología y Cirugía Torácica
Study Sponsor
Oriol Sibila, MD PhD, Principal Investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Verification Date
September 2016