This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Role of Innate Immunity in Non-Cystic Fibrosis Bronchiectasis

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2016 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor:
Collaborator:
Sociedad Española de Neumología y Cirugía Torácica
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT02163642
First received: May 19, 2014
Last updated: September 7, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention
Bronchiectasis Device: Cyranose® 320

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • Change from baseline in patterns of specific volatile organic compounds in exhaled air at 3 months [ Time Frame: Baseline and 3 months ]
    The patterns of specific volatile organic compounds in exhaled air will be determined with the electronic nose device (Cyranose® 320).

  • Change from baseline in patterns of specific volatile organic compounds in exhaled air at 6 months [ Time Frame: Baseline and 6 months ]
    The patterns of specific volatile organic compounds in exhaled air will be determined with the electronic nose device (Cyranose® 320).

  • Change from baseline in patterns of specific volatile organic compounds in exhaled air at 9 months [ Time Frame: Baseline and 9 months ]
    The patterns of specific volatile organic compounds in exhaled air will be determined with the electronic nose device (Cyranose® 320).

  • Change from baseline in patterns of specific volatile organic compounds in exhaled air at 12 months [ Time Frame: Baseline and 12 months ]
    The patterns of specific volatile organic compounds in exhaled air will be determined with the electronic nose device (Cyranose® 320).


Biospecimen Retention:   Samples With DNA
  • Serum samples
  • Sputum samples and cultures

Estimated Enrollment: 50
Study Start Date: April 2014
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Non-CF Bronchiectasis
Cyranose® 320
Device: Cyranose® 320
Detection of patterns of specific Volatile Organic Compounds in exhaled air

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02163642

Contacts
Contact: Oriol Sibila, MD PhD 0034647914193 osibila@santpau.cat

Locations
Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Oriol Sibila, MD PhD    0034647914193    osibila@santpau.cat   
Principal Investigator: Oriol Sibila, MD PhD         
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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
  More Information

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT02163642     History of Changes
Other Study ID Numbers: IIBSP-BRO-2013-154
Study First Received: May 19, 2014
Last Updated: September 7, 2016

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Bronchiectasis
Immunity

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 18, 2017