Respiratory Microbiome and COPD Exacerbations (RESMECOPD)

NCT03432234 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2020-01-23

No results posted yet for this study

Summary

The global objective of this coordinated project is to test the following hypotheses: 1) the lung microbiome in chronic obstructive pulmonary disease (COPD) is different in patients suffering from frequent exacerbations (FE) compared those who do not (NE ); 2) The microbial profile of patients with FE is associated with a different local and systemic inflammatory pattern; and 3) the inflammatory and immune characteristics of COPD are modulated by the intestinal microbiome.

The project is based on bronchoalveolar lavage (BAL) for sampling lung microbiome, and includes analysis of regional variability (intrapulmonary) and temporal variability. The project will also assess the correlation between BAL samples obtained from the proximal airway (oral cavity, oropharynx and sputum), and the representation of lung microbiome in them. A cohort of COPD patients (n = 50 FE; n = 50 NE) and healthy subjects (n= 30), matched by age, sex and tobacco consumption. Respiratory secretion samples will be collected in clinical stability samples, with resampling in a quarter of the participants at 6-9 months. Coordinator Project: Bacterial and fungal microbiota will be determined by 16S rRNA and ITS amplification and sequencing. Virome and functional metagenomics will be analyzed in a quarter of the participants. Subprojects: Regional variability in the lung, local and systemic inflammatory response, and the relationship between the intestinal microbiome and inflammatory and clinical characteristics of the disease will be determined. The integration of the results will be performed using network medicine methodologies. The results of this project will help to understand the pathogenesis of COPD and its exacerbations with the final aim to identify new therapeutic targets.

Conditions

  • Pulmonary Disease, Chronic Obstructive
  • Exacerbation COPD

Interventions

OTHER

Biomarkers

This is an observational study, there is no intervention

Sponsors & Collaborators

  • Hospital de Sant Pau

    collaborator OTHER
  • Hospital Clinic of Barcelona

    collaborator OTHER
  • Hospital Universitari de Bellvitge

    collaborator OTHER
  • Hospital del Mar

    collaborator OTHER
  • Germans Trias i Pujol Hospital

    collaborator OTHER
  • Hospital Arnau de Vilanova

    collaborator OTHER
  • Centre for Genomic Regulation

    collaborator UNKNOWN
  • Corporacion Parc Tauli

    lead OTHER

Principal Investigators

  • Oriol Sibila · Hospital de Sant Pau

  • Rosa Faner · Hospital Clínic

  • Eduard Monso · Hospital Parc Tauli

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-07
Primary Completion
2018-12-31
Completion
2020-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03432234 on ClinicalTrials.gov