Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06302959
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-03-04
Brief Title:
Clock Proteins as Prognostic Markers
Sponsor:
Medical University of Graz
Organization:
Medical University of Graz
Study Overview
Official Title:
Clock Proteins as a Prognostic Marker for Disease Progression
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
CLOCK-PM
Brief Summary:
Asthma is a chronic inflammatory disease of the airways that follows a strong circadian rhythm Signs of inflammation and symptoms worsen especially in the early morning hours The molecular circadian clock which is a complex machinery of transcriptional and translational feedback loops seems to reflect the inflammatory environment of peripheral blood leukocytes Therefore in this observational study the investigators will monitor the molecular circadian clock in patients with severe eosinophilic asthma before and during mepolizumab treatment Our major goal is to evaluate the potential of the molecular circadian clock to serve as a prognostic marker for disease progression treatment response or remission in patients with severe eosinophilic asthma The molecular circadian clock will be monitored in blood and sputum leukocytes from patients with severe eosinophilic asthma before mepolizumab treatment after 4 month of mepolizumab therapy and once they reach remission under mepolizumab treatment Effects will be compared to healthy controls and patients with mild-moderate asthma without mepolizumab treatment
Detailed Description:
Asthma is a heterogenous disease usually characterized by chronic airway inflammation that follows a strong circadian rhythm Signs of inflammation and symptoms worsen especially in the early morning hours Sudden death due to severe asthma attacks also tends to occur more frequently at night Circadian rhythms are autonomous self-sustained oscillations in biologic processes that follow a 24h-cycle and are entrained to environmental cues the most important being light At the cellular level the circadian oscillator originates from a transcriptionaltranslational feedback loop comprised of several transcription factors and nuclear receptors
Preliminary results indicate that the molecular circadian clock reflects the inflammatory environment of peripheral blood leukocytes Thus monitoring the molecular circadian clock will contribute to our understanding of asthma pathogenesis and treatment response and serve as a sensitive prognostic marker for disease progression and remission
The primary objective of this observational study is to evaluate the potential of the molecular circadian clock to serve as a prognostic marker for disease progression treatment response or remission Therefore the investigators will characterize the expression and activation of the molecular circadian clock components on the protein flow cytometry and messenger ribonucleic acid mRNA quantitative polymerase chain reaction qPCR level in peripheral blood and sputum leukocyte subsets of healthy subjects patients with mild-to-moderate asthma patients with severe eosinophilic asthma i before and ii after 4 months of mepolizumab treatment as well as iii after reaching remission under mepolizumab treatment Results will be correlated with exacerbation rates and lung function parameters As a secondary objective the investigators will elucidate how the molecular circadian clock is regulated by the inflammatory environment and if anti-asthmatic drugs or therapeutic application of synthetic clock ligands may reverse the dysbalanced clock in asthma patients Further the investigators will assess the correlation between the expression and activation of the molecular circadian clock and the inflammatory state of the patients Therefore results will be correlated with patients symptoms quality of life and cytokine levels
Preliminary results indicate that the molecular circadian clock reflects the inflammatory environment of peripheral blood leukocytes Thus monitoring the molecular circadian clock will contribute to our understanding of asthma pathogenesis and treatment response and serve as a sensitive prognostic marker for disease progression and remission
The primary objective of this observational study is to evaluate the potential of the molecular circadian clock to serve as a prognostic marker for disease progression treatment response or remission Therefore the investigators will characterize the expression and activation of the molecular circadian clock components on the protein flow cytometry and messenger ribonucleic acid mRNA quantitative polymerase chain reaction qPCR level in peripheral blood and sputum leukocyte subsets of healthy subjects patients with mild-to-moderate asthma patients with severe eosinophilic asthma i before and ii after 4 months of mepolizumab treatment as well as iii after reaching remission under mepolizumab treatment Results will be correlated with exacerbation rates and lung function parameters As a secondary objective the investigators will elucidate how the molecular circadian clock is regulated by the inflammatory environment and if anti-asthmatic drugs or therapeutic application of synthetic clock ligands may reverse the dysbalanced clock in asthma patients Further the investigators will assess the correlation between the expression and activation of the molecular circadian clock and the inflammatory state of the patients Therefore results will be correlated with patients symptoms quality of life and cytokine levels
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?:
False
Is an FDA AA801 Violation?:
None