Role of Innate Immunity in Non-Cystic Fibrosis Bronchiectasis

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 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

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