Role of Innate Immunity in Non-Cystic Fibrosis Bronchiectasis

NCT02163642 | Unknown

• 1 other identifier: IIBSP-BRO-2013-154
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis

Keywords

Bronchiectasis; Immunity

Outcome Measures

Primary Outcomes (1)

• Change from baseline in sputum mucin levels at 12 months

  Mucin levels in sputum will be determined with ELISA kits

  Baseline and 12 months

Secondary Outcomes (3)

• Change from baseline in sputum mucin levels at 3 months

  Baseline and 3 months

• Change from baseline in sputum mucin levels at 6 months

  Baseline and 6 months

• Change from baseline in sputum mucin levels at 9 months

  Baseline and 9 months

Other Outcomes (4)

• Change from baseline in patterns of specific volatile organic compounds in exhaled air at 3 months

  Baseline and 3 months

• Change from baseline in patterns of specific volatile organic compounds in exhaled air at 6 months

  Baseline and 6 months

• Change from baseline in patterns of specific volatile organic compounds in exhaled air at 9 months

  Baseline and 9 months

Study Arms (1)

Non-CF Bronchiectasis

Cyranose® 320

Device: Cyranose® 320

Interventions

Cyranose® 320 DEVICE

Detection of patterns of specific Volatile Organic Compounds in exhaled air

Non-CF Bronchiectasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Sociedad Española de Neumología y Cirugía Torácica: collaborator

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* Serum samples * Sputum samples and cultures

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Officials

• Oriol Sibila, MD PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oriol Sibila, MD PhD

CONTACT

0034647914193; osibila@santpau.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: June 13, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: September 8, 2016

Record last verified: 2016-09

Locations

ES (1)