Clinical trial NCT02163642: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bronchiectasis
Keywords: Bronchiectasis
Immunity
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Sociedad Española de Neumología y Cirugía Torácica
First posted: 2014-06-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of non-CF bronchiectasis will be recruited from the outpatient clinic of the Pneumology Service of the Sant Pau Hospital in Barcelona

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.

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

Primary outcomes:
measure: Change from baseline in sputum mucin levels at 12 months
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Change from baseline in sputum mucin levels at 3 months
timeFrame: Baseline and 3 months
measure: Change from baseline in sputum mucin levels at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in sputum mucin levels at 9 months
timeFrame: Baseline and 9 months
Other outcomes:
measure: Change from baseline in patterns of specific volatile organic compounds in exhaled air at 3 months
timeFrame: Baseline and 3 months
measure: Change from baseline in patterns of specific volatile organic compounds in exhaled air at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in patterns of specific volatile organic compounds in exhaled air at 9 months
timeFrame: Baseline and 9 months
measure: Change from baseline in patterns of specific volatile organic compounds in exhaled air at 12 months
timeFrame: Baseline and 12 months
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Oriol Sibila, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: