Role of Innate Immunity in Non-Cystic Fibrosis Bronchiectasis

Bronchiectasis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02163642
• Other study ID #: IIBSP-BRO-2013-154
• Status: Recruiting
• Phase: N/A
• First received: May 19, 2014
• Last updated: September 7, 2016
• Start date: April 2014
• Est. completion date: April 2018

Study information

• Verified date: September 2016
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Oriol Sibila, MD PhD
• Phone: 0034647914193
• Email: osibila[@]santpau.cat
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bronchiectasis
• Fibrosis

Intervention

Device:
• Cyranose® 320
Detection of patterns of specific Volatile Organic Compounds in exhaled air

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Sociedad Española de Neumología y Cirugía Torácica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Primary	Change from baseline in sputum mucin levels at 12 months	Mucin levels in sputum will be determined with ELISA kits	Baseline and 12 months	No
Secondary	Change from baseline in sputum mucin levels at 3 months	Mucin levels in sputum will be determined with ELISA kits	Baseline and 3 months	No
Secondary	Change from baseline in sputum mucin levels at 6 months	Mucin levels in sputum will be determined with ELISA kits	Baseline and 6 months	No
Secondary	Change from baseline in sputum mucin levels at 9 months	Mucin levels in sputum will be determined with ELISA kits	Baseline and 9 months	No