Atorvastatin Effect on Reduction of COPD Exacerbations

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 inclusion/exclusion 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. ;

Study Design

Related Conditions & MeSH terms

Atorvastatin
Copd
COPD Exacerbation
Gene Expression
Pulmonary Disease, Chronic Obstructive
Smoking

Clinical Trial Details

NCT number	NCT04789057
Study type	Interventional
Source	Medical University of Bialystok
Contact	Robert Mróz, Prof. MD
Phone	+48 85 74095 22
Email	robert.mroz@umb.edu.pl
Status	Recruiting
Phase	Phase 4
Start date	February 11, 2022
Completion date	December 31, 2025

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT06000696` - Healthy at Home Pilot
Active, not recruiting	`NCT03927820` - A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)	N/A
Completed	`NCT04043728` - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study	N/A
Completed	`NCT04105075` - COPD in Obese Patients
Recruiting	`NCT05825261` - Exploring Novel Biomarkers for Emphysema Detection
Active, not recruiting	`NCT04075331` - Mepolizumab for COPD Hospital Eosinophilic Admissions Pragmatic Trial	Phase 2/Phase 3
Terminated	`NCT03640260` - Respiratory Regulation With Biofeedback in COPD	N/A
Recruiting	`NCT04872309` - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Recruiting	`NCT05145894` - Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
Withdrawn	`NCT04210050` - Sleep Ventilation for Patients With Advanced Hypercapnic COPD	N/A
Terminated	`NCT03284203` - Feasibility of At-Home Handheld Spirometry	N/A
Recruiting	`NCT06110403` - Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness	Phase 1/Phase 2
Active, not recruiting	`NCT06040424` - Comparison of Ipratropium / Levosalbutamol Fixed Dose Combination and Ipratropium and Levosalbutamol Free Dose Combination in pMDI Form in Stable Chronic Obstructive Pulmonary Disease (COPD) Patients	Phase 3
Recruiting	`NCT05865184` - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Recruiting	`NCT04868357` - Hypnosis for the Management of Anxiety and Breathlessness During a Pulmonary Rehabilitation Program	N/A
Completed	`NCT01892566` - Using Mobile Health to Respond Early to Acute Exacerbations of COPD in HIV	N/A
Completed	`NCT04119856` - Outgoing Lung Team - a Cross-sectorial Intervention in Patients With COPD	N/A
Completed	`NCT04485741` - Strados System at Center of Excellence
Completed	`NCT03626519` - Effects of Menthol on Dyspnoea in COPD Patients	N/A
Recruiting	`NCT04860375` - Multidisciplinary Management of Severe COPD	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Atorvastatin Effect on Reduction of COPD Exacerbations — Captain

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms