Ignite Creation Date:
2024-05-06 @ 1:05 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03924843
Status:
COMPLETED
Last Update Posted:
2021-07-09
First Post:
2019-03-06
Brief Title:
mRNA and miRNA Airway Inflammatory Markers
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Responsivity and Reproducibility of Messenger and Micro RNA Airway Inflammatory Markers - a Pilot Study
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study investigates cytokine Messenger mRNA and microRNA miRNA level expression of interleukin IL -6 IL-8 IL-17 tumor necrosis factor TNF-alpha monocyte chemoattractant protein MCP-1 macrophage inflammatory protein MIP-1 beta and transforming growth factor TGF-beta regarding their reproducibility and responsivity in induced sputum and nasal mucosa of patients with chronic obstructive pulmonary disease COPD in order to assess their potential as a biomarker outcome measure
Detailed Description:
RationaleThere is an increased interest to identify sensitive airway biomarkers in order to evaluate the potential and efficacy of anti-inflammatory and -remodelling therapeutic interventions Biomarkers should be easily obtainable reliable and valid In COPD easily obtainable would suggest use of blood or more directly associated with the airways sputum or epithelial brushes Sputum is an obvious opportunity It has been shown that gene expression changes in the nasal mucosa might be used as suitable surrogate for epithelial cells of the lower airways in patients with airway inflammatory diseases However further studies are needed to validate these assumptions Measurement of messenger RNA and of micro RNA derived from sputum samples and nasal brushes would fulfil the ease of use required of a biomarker Messenger RNA would allow for easier quantification in variable dilution samples sputum The Groningen Research Institute for Asthma and COPD GRIAC research group has experience with sputum and nasal brushes mRNA and miRNA but more information is needed on especially reproducibility of the measurements as well as on responsivity Both are a prerequisite when designing new intervention trials with such biomarkers
Therefore the aim of this study is to investigate cytokine messenger and microRNA level expression of IL-6 IL-8 IL-17 TNF-alpha MCP-1 MIP-1 beta and TGF-beta regarding their reproducibility and responsivity in induced sputum and nasal mucosa of COPD patients in order to assess their potential as an objective outcome measure
The primary objectives of this prospective pilot study are the determination of the reproducibility and responsivity of mRNA level expression of IL-6 IL-8 TNF-alpha MCP-1 MIP-1 beta ECP and TGF-beta as airway inflammatory markers in induced sputum as well as mRNA and miRNA expression levels of IL-6 IL-8 IL-17 TNF-alpha MCP-1 MIP-1 beta and TGF-beta as airway inflammatory markers in nasal mucosa The secondary objective includes the analyses of the measurement characteristics of inflammation cell profiles LTB4 and protein levels of IL-6 IL-8 TNF-alpha MCP-1 MIP-1 beta ECP and TGF-beta
Twenty COPD patients with an initial COPD exacerbation will be followed for a period of seven weeks for three consecutive visits
The main parameters of induced sputum samples will be mRNA level expression of IL-6 IL-8 TNF-alpha MCP-1 MIP-1 beta and TGF-beta The main parameters of nasal mucosa samples will be mRNA and miRNA level expression of IL-6 IL-8 IL-17 TNF-alpha MCP-1 MIP-1 beta and TGF-beta
To allow for full perspective on the outcomes inflammatory cell profiles Leukotriene B4 LTB4 and protein levels of IL-6 IL-8 TNF-alpha MCP-1 MIP-1 beta eosinophilic cationic protein ECP and TGF-beta in sputum will be assessed
Therefore the aim of this study is to investigate cytokine messenger and microRNA level expression of IL-6 IL-8 IL-17 TNF-alpha MCP-1 MIP-1 beta and TGF-beta regarding their reproducibility and responsivity in induced sputum and nasal mucosa of COPD patients in order to assess their potential as an objective outcome measure
The primary objectives of this prospective pilot study are the determination of the reproducibility and responsivity of mRNA level expression of IL-6 IL-8 TNF-alpha MCP-1 MIP-1 beta ECP and TGF-beta as airway inflammatory markers in induced sputum as well as mRNA and miRNA expression levels of IL-6 IL-8 IL-17 TNF-alpha MCP-1 MIP-1 beta and TGF-beta as airway inflammatory markers in nasal mucosa The secondary objective includes the analyses of the measurement characteristics of inflammation cell profiles LTB4 and protein levels of IL-6 IL-8 TNF-alpha MCP-1 MIP-1 beta ECP and TGF-beta
Twenty COPD patients with an initial COPD exacerbation will be followed for a period of seven weeks for three consecutive visits
The main parameters of induced sputum samples will be mRNA level expression of IL-6 IL-8 TNF-alpha MCP-1 MIP-1 beta and TGF-beta The main parameters of nasal mucosa samples will be mRNA and miRNA level expression of IL-6 IL-8 IL-17 TNF-alpha MCP-1 MIP-1 beta and TGF-beta
To allow for full perspective on the outcomes inflammatory cell profiles Leukotriene B4 LTB4 and protein levels of IL-6 IL-8 TNF-alpha MCP-1 MIP-1 beta eosinophilic cationic protein ECP and TGF-beta in sputum will be assessed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None