Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04789057
Status:
RECRUITING
Last Update Posted:
2022-07-26
First Post:
2021-02-15
Brief Title:
Atorvastatin Effect on Reduction of COPD Exacerbations
Sponsor:
Medical University of Bialystok
Organization:
Medical University of Bialystok
Study Overview
Official Title:
Non-commercial Clinical Trial of Statins CAncer Preventive and Pleiotropic TherApy IN Smokers With Chronic Obstructive Pulmonary Disease COPD
Status:
RECRUITING
Status Verified Date:
2022-07
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:
Captain
Brief Summary:
It is a randomized multicenter prospective double-blind placebo controlled interventional clinical trial that will be conducted in Poland in about 12 Hospital Pulmonary Departments to evaluate the effectiveness of atorvastatin on the reduction of inflammation process in patients with chronic obstructive pulmonary diseases and possible biomarkers for personalized treatment of COPD
Detailed Description:
It will be a randomized double-blind two arm clinical study to assess effect of atorvastatin 40 mg treatment in patients with stable COPD The whole study duration will include three phases pre-study screening and enrollment procedures 4 weeks clinical assessment at dosing 52 weeks and post study follow up 4 weeks During the participation in the study subjects will attend Visit 1 V1 -4 weeks visit 2 V2 day 0 visit 3 V3 week6 visit 4 V4 week 12 visit 5 V5 week 26 visit 6 V6 week 38 visit 7 V7 week 52 and follow-up end of study visit EOS 56 weeks The study will begin with a 4-weeks screening phase where patients who fulfill preliminary inclusionexclusion criteria prior to entry into study will be given informed consent and screened The baseline laboratory tests clinical and medical evaluation including concomitant medication and drug of abuse will be completed to determine patient continuing eligibility to participate in the study
Upon confirmation of eligibility the patients will be randomized into two treatment groups receiving one of two medications tested in the study Each patient enrolled into the clinical study will have to report to the clinic 7 times in order to complete procedures Blood will be drawn before and during the statin or placebo treatment from patients according to study protocol This part of the project aims to develop statin response biomarkers for personalized treatment of COPD based on RNA-sequencing RNA-seq information derived from leukocytes and blood plasma of COPD patients with characterized clinical Atorvastatin response phenotypes
Upon confirmation of eligibility the patients will be randomized into two treatment groups receiving one of two medications tested in the study Each patient enrolled into the clinical study will have to report to the clinic 7 times in order to complete procedures Blood will be drawn before and during the statin or placebo treatment from patients according to study protocol This part of the project aims to develop statin response biomarkers for personalized treatment of COPD based on RNA-sequencing RNA-seq information derived from leukocytes and blood plasma of COPD patients with characterized clinical Atorvastatin response phenotypes
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019ABM0100074 | OTHER | Medical Research Agency | None |