Atorvastatin Effect on Reduction of COPD Exacerbations

NCT04789057 | Active Not Recruiting Phase 4

• 1 other identifier: 2019/ABM/01/00074
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

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.

Conditions

Copd; COPD Exacerbation; Smoking; Gene Expression; Atorvastatin

Outcome Measures

Primary Outcomes (2)

• COPD exacerbation rate

  The exacerbation of the disease (defined as an acute worsening of respiratory symptoms that results in additional therapy) will be measured during the study treatment and follow-up phases, and compared between studied groups.

  56 weeks

• Time to the COPD exacerbation

  The time to the first exacerbation will be compared between the Intervention and Placebo groups.

  56 weeks

Secondary Outcomes (7)

• Changes in forced expiratory volume in the first second (FEV1)

  56 weeks

• Changes in health-related quality of life

  56 weeks

• Changes of inflammatory pathway gene expression

  56 weeks

• Changes in peripheral blood leucocyte count

  56 weeks

• Changes in the blood fibrinogen concentrations

  56 weeks

Other Outcomes (14)

• Change from baseline in pre-dose values of plethysmography

  56 weeks

• Change in Inspiratory capacity (IC)

  56 weeks

• Change in 6 minute walking distance (6MWD) test result

  56 weeks

Study Arms (2)

Statins

EXPERIMENTAL

Atorvastatin 40 mg treatment, p.o., QD

Drug: Atorvastatin 40 Mg Oral Tablet

Placebo

PLACEBO COMPARATOR

Placebo tablet, p.o., QD

Drug: Placebo

Interventions

Atorvastatin 40 Mg Oral Tablet DRUG

p.o., once daily

Also known as: Atorvastatin

Statins

Placebo DRUG

p.o., once daily

Also known as: Placebo control group

Placebo

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has signed Informed Consent Form and is able to understand the purpose and procedures required for the study and is willing to participate in the study.
• Subject \[male or female\] is aged 40 years and older.
• Subject is able to understand and comply with the protocol requirements and instructions and is likely to complete the study as planned.
• Patients with stable COPD with persistent airflow limitation (stable COPD (post-bronchodilator FEV1\<80% of the predicted normal and post-bronchodilator FEV1/FVC\<0,70 at visit 1.) Stage II- IV) and with moderate to very severe airflow limitation according to GOLD guidelines.
• At least two moderate/severe COPD exacerbations, or at least one leading to hospitalization or ICU admission within 12 months, preceding screening visit.
• Current or ex-smokers who have a smoking history of at least 10 pack years.

You may not qualify if:

• Contraindication to statin therapy included but not limited to: known poliomyelitis, motor neuron disease, cranial or temporal arteritis, stroke or myopathy.
• Statin use within the last 3 months prior to study start.
• Prior diagnosis of statin induced myopathy or hypersensitivity reaction to another HMG-CoA-reductase inhibitor.
• Using e-cigarettes or I IQOS tobacco heating system.
• Pregnant or nursing (lactating) women.
• Women of child bearing potential, unless they are using effective method of contraception during dosing of study treatment.
• Patient with a clinically significant abnormality at visit 1 in investigator opinion.
• Patients with a clinically relevant laboratory abnormality at visit 1 in investigator opinion.
• Patients with a history of malignancy of any organ system (including lung cancer).
• Patients unable to perform acceptable spirometry and lung volumes procedures.
• Patients who had a COPD exacerbations that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the 6 weeks prior to visit 1.
• Patients who have had a respiratory tract infection within 4 weeks prior to visit1.
• Patients requiring oxygen therapy (\>15hr/day) on a daily basis for chronic hypoxemia.
• Patients with a history of asthma or onset of symptoms prior to age 40 years
• Patients with concomitant pulmonary disease (e.g. lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, tuberculosis).

Sponsors & Collaborators

• Medical University of Bialystok: lead
• Medical Research Agency, Poland: collaborator

Study Sites (1)

Medical University Hospital

Bialystok, 15-540, Poland

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Smoking

Interventions

Atorvastatin; Tablets

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Robert Mróz, Prof. MD

  Medical University of Bialystok

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: March 9, 2021
• Study Start: February 11, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)