Pulmonary Disease, Chronic ObstructiveRESMECOPDNCT03432234
Respiratory Microbiome and COPD Exacerbations (RESMECOPD)
An observational study of Pulmonary Disease, Chronic Obstructive and Exacerbation COPD, run by Corporacion Parc Tauli at 6 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Exacerbation COPD
- What is being tested?
- Biomarkers
- How many people
- 120 participants
- Where
- 6 sitesSpain
- Study dates
- 7 Mar 2016to Dec 2020
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Eligible subjects were COPD patients GOLD II/III in stable situation.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Hospital Germans Trias i Pujol
Badalona
Hospital Clínic
Barcelona
Hospital de Bellitge
Barcelona
Hospital del Mar
Barcelona
Hosptial de Sant Pau
Barcelona
Corporació Sanitaria Parc Tauli
Sabadell, Barcelona, 08208
About this study
Official title: Respiratory Microbiome and COPD Exacerbations
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.
- Being tested
- Biomarkers
- Keywords
- COPD, Microbiome, Exacerbation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiomarkersOther
This is an observational study, there is no intervention
| Study group | Role | What they receive |
|---|---|---|
| COPD and frequent exacerbation | Patient with COPD diagnosis and at least two exacerbations by year (FE) Receives: Other: Biomarkers | |
| COPD no frequent exacerbation | Patient with COPD diagnosis with no frequent exacerbation, less than 2 by year (NE). Receives: Other: Biomarkers | |
| Healthy (control) | Healthy volunteers patients (H) Receives: Other: Biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Microbiome in COPD patients with FE and NE.
Respiratory Microbiome composition will be determined by using metagenomic aproaches.
Measured: 7 days
Secondary outcomes (3)
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.
Measured: 7 days
Longitudinal variability of respiratory microbiome in COPD patients (FE vs NE).
Change of respiratory Microbiome (diversity and abundance)
Measured: 12 months
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start7 Mar 2016
- Primary completion31 Dec 2018
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Sant Pau, Hospital Clinic of Barcelona, Hospital Universitari de Bellvitge, Hospital del Mar, Germans Trias i Pujol Hospital, Hospital Arnau de Vilanova, Centre for Genomic Regulation
- Responsible party
- Principal investigator, Eduard Monsó-Molas, Corporacion Parc Tauli
- Investigators
- Oriol Sibila, Principal investigator, Hospital de Sant PauRosa Faner, Principal investigator, Hospital ClínicEduard Monso, Study director, Hospital Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432234
- Sponsor's protocol ID
- PI15/0157 (2015607)
- Acronym
- RESMECOPD
- Status last verified
- Jan 2020
- First submitted
- 8 Jan 2018
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sequencing data will be available in public databases.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Microbiome and COPD Exacerbations
- ClinicalTrials.gov ID
- NCT03432234
- Acronym / sponsor ID
- RESMECOPD / PI15/0157 (2015607)
- Keywords
- COPD, Microbiome, Exacerbation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Hospital de Sant Pau, Hospital Clinic of Barcelona, Hospital Universitari de Bellvitge, Hospital del Mar, Germans Trias i Pujol Hospital, Hospital Arnau de Vilanova, Centre for Genomic Regulation
- Study start
- 7 Mar 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 14 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COPD and frequent exacerbation | – | Other: BiomarkersPatient with COPD diagnosis and at least two exacerbations by year (FE) |
| COPD no frequent exacerbation | – | Other: BiomarkersPatient with COPD diagnosis with no frequent exacerbation, less than 2 by year (NE). |
| Healthy (control) | – | Other: BiomarkersHealthy volunteers patients (H) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible subjects were COPD patients GOLD II/III in stable situation.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiomarkersThis is an observational study, there is no intervention | Other | COPD and frequent exacerbation, COPD no frequent exacerbation, Healthy (control) |
Primary outcome
Respiratory Microbiome in COPD patients with FE and NE.
Time frame: 7 days
Respiratory Microbiome composition will be determined by using metagenomic aproaches.
3 secondary outcomes
Bacteria related to pulmonary and systemic inflamatory factors (FE vs NE)
Time frame: 7 days
Longitudinal variability of respiratory microbiome in COPD patients (FE vs NE).
Time frame: 12 months
Inmunological response of lung epithelial cells COPD patients after an infectious and inflammatory stimuli
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: Undecided. Sequencing data will be available in public databases.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oriol Sibila principal investigator
Hospital de Sant Pau
Rosa Faner principal investigator
Hospital Clínic
Eduard Monso study director
Hospital Parc Tauli
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive and Exacerbation COPD, run by Corporacion Parc Tauli at 6 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Microbiome in COPD patients with FE and NE. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020; AzTrials last refreshed its copy on 29 Oct 2026.