Respiratory Microbiome in COPD and Associated Inmune Response.
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 23, 2017
CompletedFirst Posted
Study publicly available on registry
October 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedOctober 26, 2017
October 1, 2017
2 years
October 23, 2017
October 23, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
Clinically stable COPD patients.
You may qualify if:
- Diagnosis of COPD according to national and international guidelines.
- Clinical stability (8 previous weeks).
- Signature of informed consent.
You may not qualify if:
- Antibiotic treatment the previous 8 weeks.
- Other lung diseases.
- Active neoplasic disease.
- Terminal concomitant disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oriol Sibila Vidal
Barcelona, 08041, Spain
Related Publications (10)
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.
PMID: 22798317BACKGROUNDRoy 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.
PMID: 24317696BACKGROUNDKirkham 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.
PMID: 18776153BACKGROUNDFujisawa T, Chang MM, Velichko S, Thai P, Hung LY, Huang F, Phuong N, Chen Y, Wu R. NF-kappaB mediates IL-1beta- 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.
PMID: 20935193BACKGROUNDYang 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. doi: 10.1146/annurev.immunol.22.012703.104603.
PMID: 15032578BACKGROUNDHarder J, Meyer-Hoffert U, Teran LM, Schwichtenberg L, Bartels J, Maune S, Schroder 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. doi: 10.1165/ajrcmb.22.6.4023.
PMID: 10837369BACKGROUNDParameswaran 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.
PMID: 21349930BACKGROUNDMillares L, Marin A, Garcia-Aymerich J, Sauleda J, Belda J, Monso 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(1):113. doi: 10.1186/1465-9921-13-113.
PMID: 23228114BACKGROUNDMedzhitov R. Toll-like receptors and innate immunity. Nat Rev Immunol. 2001 Nov;1(2):135-45. doi: 10.1038/35100529.
PMID: 11905821BACKGROUNDClarke 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.
PMID: 20081863BACKGROUND
Biospecimen
Sputum, oral swabs, oral lavage, saliva, brochoalveolar lavage (BAL), bronchial brush, peripheral blood, feces.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oriol Sibila Vidal, PhD
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2017
First Posted
October 26, 2017
Study Start
March 1, 2016
Primary Completion
March 1, 2018
Study Completion
December 1, 2018
Last Updated
October 26, 2017
Record last verified: 2017-10