Respiratory Microbiome and COPD Exacerbations (RESMECOPD)

Pulmonary Disease, Chronic Obstructive Clinical Trial

— RESMECOPD  

Official title:

Respiratory Microbiome and COPD Exacerbations

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03432234
• Other study ID #: PI15/0157 (2015607)
• Status: Active, not recruiting
• Start date: March 7, 2016
• Est. completion date: December 2020

Study information

• Verified date: January 2020
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 2020
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exacerbation COPD
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Biomarkers
This is an observational study, there is no intervention

Locations

Country	Name	City	State
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	Corporació Sanitaria Parc Tauli	Sabadell	Barcelona

Sponsors (8)

Lead Sponsor	Collaborator
Corporacion Parc Tauli	Centre for Genomic Regulation, Germans Trias i Pujol Hospital, Hospital Arnau de Vilanova, Hospital Clinic of Barcelona, Hospital de Sant Pau, Hospital del Mar, Hospital Universitari de Bellvitge

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Spatial variability of respiratory microbiome in COPD patients (FE vs NE).	Respiratory Microbiome Composition of different types of samples.	1 day
Primary	Respiratory Microbiome in COPD patients with FE and NE.	Respiratory Microbiome composition will be determined by using metagenomic aproaches.	7 days
Secondary	Bacteria related to pulmonary and systemic inflamatory factors (FE vs NE)	Determination of pulmonary and systemic markers with ELISA kit. Microbiome will be determined by metagenomic techniques.	7 days
Secondary	Longitudinal variability of respiratory microbiome in COPD patients (FE vs NE).	Change of respiratory Microbiome (diversity and abundance)	12 months
Secondary	Inmunological response of lung epithelial cells COPD patients after an infectious and inflammatory stimuli	The in vitro response of epithelial cells will be determined with ELISA kits.	7 days