Clinical trial NCT03321708: Respiratory Microbiome in COPD and Associated Inmune Response.
Official title: Respiratory Microbiome in COPD. Relationship With Systemic and Pulmonary Inmune Response.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Disease (COPD), Chronic Obstructive
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2017-10-26
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Clinically stable COPD patients.

Brief summary: Hypothesis:

COPD patients with frequent exacerbations have different pulmonary and systemic immune response than COPD patients without frequent exacerbations and this is related to their microbiome.

Detailed description: The objective of this project is to determine the pulmonary microbiome and its relationship with the pulmonary and systemic inmune response in COPD patients with frequent (FE) and non frequent exacerbations (NE).

1. The pulmonary immune response.

   -The role of mucins, antimicrobial peptides (AMPs), Matrix metalloproteinases (MMPs) and Toll-like receptors (TLRs) as lung defense mechanisms and their possible relationship with the microbiome in COPD and FE patients.
2. The systemic immune response. -The pulmonary and blood inflammatory response and circulating bacterial products as markers of the systemic immune response.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of COPD according to national and international guidelines.
2. Clinical stability (8 previous weeks).
3. Signature of informed consent.

Exclusion Criteria:

1. Antibiotic treatment the previous 8 weeks.
2. Other lung diseases.
3. Active neoplasic disease.
4. Terminal concomitant disease.

Primary outcomes:
measure: Relationship of pulmonary microbiome with the immune response (local and systemic).
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Oriol Sibila Vidal
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Oriol Sibila Vidal, PhD
role: PRINCIPAL_INVESTIGATOR
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