CopdPhase 4CaptainNCT04789057
Atorvastatin Effect on Reduction of COPD Exacerbations
A Phase 4 study testing Atorvastatin 40 Mg Oral Tablet in people with Copd and COPD Exacerbation, run by Medical University of Bialystok at 1 site in Poland.
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… Read more about this study
- Who is it for?
- Ages 40 to 99 years
- Conditions the study is for
- Copd, COPD Exacerbation, Smoking
- What is being tested?
- Atorvastatin 40 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 460 participants
- Where
- 1 sitePoland
- Study dates
- 11 Feb 2022to 31 May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 23Show fewer
- 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).
- Patients with primary bronchiectasis.
- Patients with a diagnosis of α-1 antitrypsin deficiency (AATD).
- Patients with pulmonary lobectomy or lung volume reduction surgery or lung transplantation.
- Active abuse of drugs or alcohol, poor compliance anticipated.
- Use concomitant medications that are known to interact with atorvastatin: warfarin and other coumarin (vitamin K antagonists) anticoagulants, cyclosporin, gemfibrozil or other non or selective nonsteroidal anti-inflammatory drugs, proton pump inhibitors (PPIs) used by last 6 months.
- Patients participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the study.
- Use of other investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening visit.
- Those unable in the opinion of the Investigator to comply fully with the study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-commercial Clinical Trial of Statins CAncer Preventive and Pleiotropic TherApy IN Smokers With Chronic Obstructive Pulmonary Disease (COPD)
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.
Read the 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 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.
- Conditions
- Copd, COPD Exacerbation, Smoking, Gene Expression, Atorvastatin
- Being tested
- Atorvastatin 40 Mg Oral Tablet, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 40 Mg Oral TabletDrug
Also called Atorvastatin
p.o., once daily
PlaceboDrug
Also called Placebo control group
p.o., once daily
| Study group | Role | What they receive |
|---|---|---|
| Statins | Experimental | Atorvastatin 40 mg treatment, p.o., QD Receives: Drug: Atorvastatin 40 Mg Oral Tablet |
| Placebo | Placebo comparator | Placebo tablet, p.o., QD Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 56 weeks
Time to the COPD exacerbation
The time to the first exacerbation will be compared between the Intervention and Placebo groups.
Measured: 56 weeks
Secondary outcomes (7)
Changes in forced expiratory volume in the first second (FEV1)
The differences in absolute value between Placebo and Atorvastatin group will be evaluated in time points [Visit 1 ,Visit 3,Visit 4, Visit 5, Visit 6 and Visit 8], and the relative change between Visit 1 and following time points [Visit 3 - Visit 8] in both arms will be compared.
Measured: 56 weeks
Changes in health-related quality of life
The St George's Respiratory Questionnaire (SGRQ) score will be used and the differences in absolute value between Placebo and Atorvastatin group will be evaluated in time points [Visit 2 , Visit 5, and Visit 7], as well as the - relative change between Visit 2 and following time points [Visit 5 and Visit 7] in both arms will be compared. Scores range from 0 to 100; higher scores indicating more limitations.
Measured: 56 weeks
Changes of inflammatory pathway gene expression
The gene expression will be evaluated in the peripheral blood leucocytes (PBL) by RNA-seq analysis, at visit Visit 1, Visit 2, Visit 5 and Visit 7, and the differences between Placebo and Atorvastatin groups will be analyzed, as well as a relative change between visits Visit 1 and Visit 2, Visit 5 and Visit 7 in both arms will be compared.
Measured: 56 weeks
Changes in peripheral blood leucocyte count
The peripheral blood leucocytes count will be measured and the differences in absolute values between Placebo and Atorvastatin group will be calculated in time points Visit 1 ,Visit 3, Visit 5 and Visit 7, as well as a relative change between visits Visit 1 and Visit 2, Visit 3, Visit 5 , Visit 7 in both arms will be compared.
Measured: 56 weeks
Changes in the blood fibrinogen concentrations
A blood fibrinogen concentration will be measured and the differences in absolute values between Placebo and Atorvastatin group will be calculated in time points Visit 1 ,Visit 3, Visit 5 and Visit 7, as well as a relative change between visits Visit 1 and Visit 2, Visit 3, Visit 5 , Visit 7 in both arms will be compared.
Measured: 56 weeks
Changes in the blood Interleukin-6 concentrations
The Interleukin-6 blood concentrations will be measured and the differences in absolute values between Placebo and Atorvastatin group will be calculated in time points Visit 1 ,Visit 3, Visit 5 and Visit 7, as well as a relative change between visits Visit 1 and Visit 2, Visit 3, Visit 5 , Visit 7 in both arms will be compared.
Measured: 56 weeks
Changes in the blood high sensitivity C - reactive protein concentrations
The blood high sensitivity C - reactive protein concentrations will be measured and the differences in absolute values between Placebo and Atorvastatin group will be calculated in time points Visit 1 ,Visit 3, Visit 5 and Visit 7, as well as a relative change between visits Visit 1 and Visit 2, Visit 3, Visit 5 , Visit 7 in both arms will be compared.
Measured: 56 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start11 Feb 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Responsible party
- Sponsor
- Investigators
- Robert Mróz, Prof. MD, Principal investigator, Medical University of Bialystok
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789057
- Sponsor's protocol ID
- 2019/ABM/01/00074
- Other IDs
- 2019/ABM/01/00074
- Acronym
- Captain
- Status last verified
- Apr 2026
- First submitted
- 15 Feb 2021
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the agreement with the funding institution (Medical Research Agency), the sponsor and research centers must obtain the consent of the funding institution to disclose the clinical trial data.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-commercial Clinical Trial of Statins CAncer Preventive and Pleiotropic TherApy IN Smokers With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT04789057
- Acronym / sponsor ID
- Captain / 2019/ABM/01/00074
- Conditions
- Copd, COPD Exacerbation, Smoking, Gene Expression, Atorvastatin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Statins | Experimental | Drug: Atorvastatin 40 Mg Oral TabletAtorvastatin 40 mg treatment, p.o., QD |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablet, p.o., QD |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin 40 Mg Oral TabletAlso: Atorvastatinp.o., once daily | Drug | Statins |
| PlaceboAlso: Placebo control groupp.o., once daily | Drug | Placebo |
Primary outcome
COPD exacerbation rate
Time frame: 56 weeks
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.
Time to the COPD exacerbation
Time frame: 56 weeks
The time to the first exacerbation will be compared between the Intervention and Placebo groups.
7 secondary outcomes
Changes in forced expiratory volume in the first second (FEV1)
Time frame: 56 weeks
Changes in health-related quality of life
Time frame: 56 weeks
Changes of inflammatory pathway gene expression
Time frame: 56 weeks
Changes in peripheral blood leucocyte count
Time frame: 56 weeks
Changes in the blood fibrinogen concentrations
Time frame: 56 weeks
Changes in the blood Interleukin-6 concentrations
Time frame: 56 weeks
Changes in the blood high sensitivity C - reactive protein concentrations
Time frame: 56 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No. According to the agreement with the funding institution (Medical Research Agency), the sponsor and research centers must obtain the consent of the funding institution to disclose the clinical trial data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Mróz, Prof. MD principal investigator
Medical University of Bialystok
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin 40 Mg Oral Tablet in people with Copd and COPD Exacerbation, run by Medical University of Bialystok at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COPD exacerbation rate (time frame: 56 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.