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Role of Innate Immunity in Non-Cystic Fibrosis Bronchiectasis

F

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

Status

Unknown

Conditions

Bronchiectasis

Treatments

Device: Cyranose® 320

Study type

Observational

Funder types

Other

Identifiers

NCT02163642
IIBSP-BRO-2013-154

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Non-CF Bronchiectasis
Description:
Cyranose® 320
Treatment:
Device: Cyranose® 320

Trial contacts and locations

1

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Central trial contact

Oriol Sibila, MD PhD

Data sourced from clinicaltrials.gov

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