Respiratory Microbiome and COPD Exacerbations (RESMECOPD)
RESMECOPD
1 other identifier
observational
120
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2016
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 7, 2016
CompletedFirst Submitted
Initial submission to the registry
January 8, 2018
CompletedFirst Posted
Study publicly available on registry
February 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJanuary 23, 2020
January 1, 2020
2.8 years
January 8, 2018
January 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Respiratory Microbiome in COPD patients with FE and NE.
Respiratory Microbiome composition will be determined by using metagenomic aproaches.
7 days
Secondary Outcomes (3)
Bacteria related to pulmonary and systemic inflamatory factors (FE vs NE)
7 days
Longitudinal variability of respiratory microbiome in COPD patients (FE vs NE).
12 months
Inmunological response of lung epithelial cells COPD patients after an infectious and inflammatory stimuli
7 days
Other Outcomes (1)
Spatial variability of respiratory microbiome in COPD patients (FE vs NE).
1 day
Study Arms (3)
COPD and frequent exacerbation
Patient with COPD diagnosis and at least two exacerbations by year (FE)
COPD no frequent exacerbation
Patient with COPD diagnosis with no frequent exacerbation, less than 2 by year (NE).
Healthy (control)
Healthy volunteers patients (H)
Interventions
This is an observational study, there is no intervention
Eligibility Criteria
Eligible subjects were COPD patients GOLD II/III in stable situation.
You may qualify if:
- Spirometry: FEV1/FVC \< 70%; FEV1 between 50 and 80% predicted (GOLD II/III)
- Clinical Stability (no therapeutic change and/or use of antibiotics) during 8 weeks. - The treatment received will be registered for post-hoc studies stratified by this condition.
You may not qualify if:
- Drug addiction, alcohol abuse,
- Use of long-term oral or nebulised antibiotic therapy.
- History of allergies, asthma or other chronic respiratory disease, sanitary worker, working exposure to dust or fumes.
- Other diseases: Severe cardiovascular, neurological, psychiatric, renal, hepatic or gastrointestinal , that might interfere with the daily life activities.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Corporacion Parc Taulilead
- Hospital de Sant Paucollaborator
- Hospital Clinic of Barcelonacollaborator
- Hospital Universitari de Bellvitgecollaborator
- Hospital del Marcollaborator
- Germans Trias i Pujol Hospitalcollaborator
- Hospital Arnau de Vilanovacollaborator
- Centre for Genomic Regulationcollaborator
Study Sites (6)
Corporació Sanitaria Parc Tauli
Sabadell, Barcelona, 08208, Spain
Hospital Germans Trias i Pujol
Badalona, Spain
Hospital Clínic
Barcelona, Spain
Hospital de Bellitge
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hosptial de Sant Pau
Barcelona, Spain
Biospecimen
Oral Wash, oropharingeal swab, sputum, brochoalveolar lavage, feces, plasma, serum, white blood cells.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oriol Sibila
Hospital de Sant Pau
- PRINCIPAL INVESTIGATOR
Rosa Faner
Hospital Clínic
- STUDY DIRECTOR
Eduard Monso
Hospital Parc Tauli
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Respiratory Medicine Department
Study Record Dates
First Submitted
January 8, 2018
First Posted
February 14, 2018
Study Start
March 7, 2016
Primary Completion
December 31, 2018
Study Completion
December 1, 2020
Last Updated
January 23, 2020
Record last verified: 2020-01