Status:
RECRUITING
Atorvastatin Effect on Reduction of COPD Exacerbations
Lead Sponsor:
Medical University of Bialystok
Collaborating Sponsors:
Medical Research Agency, Poland
Conditions:
Copd
COPD Exacerbation
Eligibility:
All Genders
40-99 years
Phase:
PHASE4
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 t...
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-stu...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
- 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.
Key Trial Info
Start Date :
February 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT04789057
Start Date
February 11 2022
End Date
May 31 2027
Last Update
May 8 2025
Active Locations (1)
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1
Medical University Hospital
Bialystok, Poland, 15-540