Respiratory Microbiome in COPD and Associated Inmune Response.

Pulmonary Disease (COPD), Chronic Obstructive Clinical Trial

Official title:

Respiratory Microbiome in COPD. Relationship With Systemic and Pulmonary Inmune Response.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03321708
• Other study ID #: IIBSP-MIC-2015-57
• Status: Recruiting
• Phase: N/A
• First received: October 23, 2017
• Last updated: October 23, 2017
• Start date: March 2016
• Est. completion date: December 2018

Study information

• Verified date: October 2017
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Oriol Sibila, PhD
• Phone: 932919000
• Email: osibila[@]santpau.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease (COPD), Chronic Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Spain	Oriol Sibila Vidal	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

References & Publications (10)

Clarke TB, Davis KM, Lysenko ES, Zhou AY, Yu Y, Weiser JN. Recognition of peptidoglycan from the microbiota by Nod1 enhances systemic innate immunity. Nat Med. 2010 Feb;16(2):228-31. doi: 10.1038/nm.2087. Epub 2010 Jan 17. — View Citation

Fujisawa T, Chang MM, Velichko S, Thai P, Hung LY, Huang F, Phuong N, Chen Y, Wu R. NF-?B mediates IL-1ß- and IL-17A-induced MUC5B expression in airway epithelial cells. Am J Respir Cell Mol Biol. 2011 Aug;45(2):246-52. doi: 10.1165/rcmb.2009-0313OC. Epub 2010 Oct 8. — View Citation

Harder J, Meyer-Hoffert U, Teran LM, Schwichtenberg L, Bartels J, Maune S, Schröder JM. Mucoid Pseudomonas aeruginosa, TNF-alpha, and IL-1beta, but not IL-6, induce human beta-defensin-2 in respiratory epithelia. Am J Respir Cell Mol Biol. 2000 Jun;22(6):714-21. — View Citation

Kirkham S, Kolsum U, Rousseau K, Singh D, Vestbo J, Thornton DJ. MUC5B is the major mucin in the gel phase of sputum in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2008 Nov 15;178(10):1033-9. doi: 10.1164/rccm.200803-391OC. Epub 2008 Sep 5. — View Citation

Medzhitov R. Toll-like receptors and innate immunity. Nat Rev Immunol. 2001 Nov;1(2):135-45. Review. — View Citation

Millares L, Marin A, Garcia-Aymerich J, Sauleda J, Belda J, Monsó E; PAC-COPD Study Group. Specific IgA and metalloproteinase activity in bronchial secretions from stable chronic obstructive pulmonary disease patients colonized by Haemophilus influenzae. Respir Res. 2012 Dec 11;13:113. doi: 10.1186/1465-9921-13-113. — View Citation

Mizgerd JP. Respiratory infection and the impact of pulmonary immunity on lung health and disease. Am J Respir Crit Care Med. 2012 Nov 1;186(9):824-9. doi: 10.1164/rccm.201206-1063PP. Epub 2012 Jul 12. — View Citation

Parameswaran GI, Sethi S, Murphy TF. Effects of bacterial infection on airway antimicrobial peptides and proteins in COPD. Chest. 2011 Sep;140(3):611-617. doi: 10.1378/chest.10-2760. Epub 2011 Feb 24. — View Citation

Roy MG, Livraghi-Butrico A, Fletcher AA, McElwee MM, Evans SE, Boerner RM, Alexander SN, Bellinghausen LK, Song AS, Petrova YM, Tuvim MJ, Adachi R, Romo I, Bordt AS, Bowden MG, Sisson JH, Woodruff PG, Thornton DJ, Rousseau K, De la Garza MM, Moghaddam SJ, Karmouty-Quintana H, Blackburn MR, Drouin SM, Davis CW, Terrell KA, Grubb BR, O'Neal WK, Flores SC, Cota-Gomez A, Lozupone CA, Donnelly JM, Watson AM, Hennessy CE, Keith RC, Yang IV, Barthel L, Henson PM, Janssen WJ, Schwartz DA, Boucher RC, Dickey BF, Evans CM. Muc5b is required for airway defence. Nature. 2014 Jan 16;505(7483):412-6. doi: 10.1038/nature12807. Epub 2013 Dec 8. — View Citation

Yang D, Biragyn A, Hoover DM, Lubkowski J, Oppenheim JJ. Multiple roles of antimicrobial defensins, cathelicidins, and eosinophil-derived neurotoxin in host defense. Annu Rev Immunol. 2004;22:181-215. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship of pulmonary microbiome with the immune response (local and systemic).	Microbiome will be determined by using 16s RNA techniques. The inmune response will be studied with ELISA kits.	6 months