Clinical trial NCT03432234: Respiratory Microbiome and COPD Exacerbations (RESMECOPD)
Official title: Respiratory Microbiome and COPD Exacerbations
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Disease, Chronic Obstructive
Exacerbation COPD
Keywords: COPD
Microbiome
Exacerbation
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
Collaborators: name: Hospital de Sant Pau
name: Hospital Clinic of Barcelona
name: Hospital Universitari de Bellvitge
name: Hospital del Mar
name: Germans Trias i Pujol Hospital
name: Hospital Arnau de Vilanova
name: Centre for Genomic Regulation
First posted: 2018-02-14
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible subjects were COPD patients GOLD II/III in stable situation.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Respiratory Microbiome in COPD patients with FE and NE.
timeFrame: 7 days
Secondary outcomes:
measure: Bacteria related to pulmonary and systemic inflamatory factors (FE vs NE)
timeFrame: 7 days
measure: Longitudinal variability of respiratory microbiome in COPD patients (FE vs NE).
timeFrame: 12 months
measure: Inmunological response of lung epithelial cells COPD patients after an infectious and inflammatory stimuli
timeFrame: 7 days
Other outcomes:
measure: Spatial variability of respiratory microbiome in COPD patients (FE vs NE).
timeFrame: 1 day
Locations:
city: Sabadell
country: Spain
facility: Corporació Sanitaria Parc Tauli
state: Barcelona
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Clínic
city: Barcelona
country: Spain
facility: Hospital de Bellitge
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hosptial de Sant Pau
Study officials:
affiliation: Hospital de Sant Pau
name: Oriol Sibila
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínic
name: Rosa Faner
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Parc Tauli
name: Eduard Monso
role: STUDY_DIRECTOR
References: