Role of Innate Immunity in Non-Cystic Fibrosis Bronchiectasis

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

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.

Study Overview

• Status: Unknown
• Conditions: Bronchiectasis
• Intervention / Treatment: Device: Cyranose® 320

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
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Oriol Sibila, MD PhD; Phone Number: 0034647914193; Email: osibila@santpau.cat

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Recruiting
    • Hospital de la Santa Creu i Sant Pau
    • Contact: Oriol Sibila, MD PhD; Phone Number: 0034647914193; Email: osibila@santpau.cat
    • Principal Investigator: Oriol Sibila, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-CF Bronchiectasis; Cyranose® 320	Device: Cyranose® 320; Detection of patterns of specific Volatile Organic Compounds in exhaled air

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in patterns of specific volatile organic compounds in exhaled air at 3 months	The patterns of specific volatile organic compounds in exhaled air will be determined with the electronic nose device (Cyranose® 320).	Baseline and 3 months
Change from baseline in patterns of specific volatile organic compounds in exhaled air at 6 months	The patterns of specific volatile organic compounds in exhaled air will be determined with the electronic nose device (Cyranose® 320).	Baseline and 6 months
Change from baseline in patterns of specific volatile organic compounds in exhaled air at 9 months	The patterns of specific volatile organic compounds in exhaled air will be determined with the electronic nose device (Cyranose® 320).	Baseline and 9 months
Change from baseline in patterns of specific volatile organic compounds in exhaled air at 12 months	The patterns of specific volatile organic compounds in exhaled air will be determined with the electronic nose device (Cyranose® 320).	Baseline and 12 months

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Collaborators: Sociedad Española de Neumología y Cirugía Torácica
• Investigators: Principal Investigator: Oriol Sibila, MD PhD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: May 19, 2014
• First Submitted That Met QC Criteria: June 11, 2014
• First Posted (Estimate): June 13, 2014

Study Record Updates

• Last Update Posted (Estimate): September 8, 2016
• Last Update Submitted That Met QC Criteria: September 7, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Immunity; Bronchiectasis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis
• Other Study ID Numbers: IIBSP-BRO-2013-154