Role of Innate Immunity in Non-Cystic Fibrosis Bronchiectasis

NCT ID: NCT02163642

Last Updated: 2016-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2018-04-30

Brief Summary

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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

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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.

Conditions

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Bronchiectasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-CF Bronchiectasis

Cyranose® 320

Cyranose® 320

Intervention Type DEVICE

Detection of patterns of specific Volatile Organic Compounds in exhaled air

Interventions

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Cyranose® 320

Detection of patterns of specific Volatile Organic Compounds in exhaled air

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sociedad Española de Neumología y Cirugía Torácica

OTHER

Sponsor Role collaborator

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oriol Sibila, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Locations

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Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Oriol Sibila, MD PhD

Role: CONTACT

0034647914193

Facility Contacts

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Oriol Sibila, MD PhD

Role: primary

0034647914193

Other Identifiers

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IIBSP-BRO-2013-154

Identifier Type: -

Identifier Source: org_study_id

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