Clinical Trial: Role of Innate Immunity in Non-Cystic Fibrosis Bronchiectasis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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 Summary: 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.
Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Current Primary Outcome: Change from baseline in sputum mucin levels at 12 months [ Time Frame: Baseline and 12 months ]

Mucin levels in sputum will be determined with ELISA kits


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in sputum mucin levels at 3 months [ Time Frame: Baseline and 3 months ]
    Mucin levels in sputum will be determined with ELISA kits
  • Change from baseline in sputum mucin levels at 6 months [ Time Frame: Baseline and 6 months ]
    Mucin levels in sputum will be determined with ELISA kits
  • Change from baseline in sputum mucin levels at 9 months [ Time Frame: Baseline and 9 months ]
    Mucin levels in sputum will be determined with ELISA kits


Original Secondary Outcome: Same as current

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

Dates:
Date Received: May 19, 2014
Date Started: April 2014
Date Completion: April 2018
Last Updated: September 7, 2016
Last Verified: September 2016