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    Summary
    EudraCT Number:2020-005641-17
    Sponsor's Protocol Code Number:2019/ABM/01/00074
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-08-16
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-005641-17
    A.3Full title of the trial
    Non-commercial clinical trial of statins CAncer preventive and Pleiotropic TherApy IN smokers with chronic obstructive pulmonary disease (COPD)
    Clinical part: Atorvastatin effect on reduction of COPD exacerbations.
    Genomic part: Assessment of immunobiology of COPD related lung carcinoma and inflammatory pathways activation based on gene expression profiles of the peripheral blood leukocytes (PBLs) and peripheral blood mononuclear cells (PBMCs) from smokers with chronic obstructive pulmonary disease (COPD).
    Niekomercyjne badanie kliniczne terapii plejotropowej i profilaktyki raka u palących tytoń pacjentów z przewlekłą obturacyjną chorobą płuc (POChP) przyjmujących statyny.
    Część kliniczna: Wpływ terapii atorwastatyną na częstość zaostrzeń w przebiegu POChP.

    Część genomiczna: Ocena immunobiologii raka płuca związanego z POChP i aktywacji szlaków zapalnych na podstawie profili ekspresji genów leukocytów krwi obwodowej (PBL) oraz jednojądrzastych komórek krwi obwodowej (PBMCs) u pacjentów z POChP leczonych i nieleczonych statynami.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial of statins CAncer preventive and Pleiotropic TherApy IN smokers with chronic obstructive pulmonary disease (COPD)
    Badanie kliniczne terapii plejotropowej i profilaktyki raka u pacjentów z przewleką obturacyjną chorobą płuc (POChP) przyjmujących statyny.
    A.3.2Name or abbreviated title of the trial where available
    CAPTAIN STUDY
    A.4.1Sponsor's protocol code number2019/ABM/01/00074
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMedical University of Bialystok
    B.1.3.4CountryPoland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMedical Research Agency
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Bialystok
    B.5.2Functional name of contact pointStudy coordinator
    B.5.3 Address:
    B.5.3.1Street AddressŻurawia 14
    B.5.3.2Town/ cityBiałystok
    B.5.3.3Post code15-540
    B.5.3.4CountryPoland
    B.5.4Telephone number+4885740 95 22
    B.5.6E-mailrobmmroz@gmail.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Atoris, 40mg
    D.2.1.1.2Name of the Marketing Authorisation holderKRKA-POLSKA Sp. z o.o.
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNATORVASTATIN
    D.3.9.1CAS number 134523-00-5
    D.3.9.4EV Substance CodeSUB05600MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic obstructive pulmonary disease (COPD)
    E.1.1.1Medical condition in easily understood language
    Is a type of obstructive lung disease characterized by long-term breathing problems and poor airflow.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 27.1
    E.1.2Level PT
    E.1.2Classification code 10009033
    E.1.2Term Chronic obstructive pulmonary disease
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of clinical part of this study is to compare the effectiveness of atorvastatin with a matched placebo control on the reduction of COPD exacerbations in patients with chronic obstructive pulmonary diseases.
    E.2.2Secondary objectives of the trial
    The secondary objective of clinical part of this study is to compare the effectiveness of atorvastatin with a matched placebo control on lung function and health related quality of life changes in patients with chronic obstructive pulmonary diseases.
    The secondary objective of genomic part is to provide with evidence that atorvastatin exerts direct anti-inflammatory activity regulated on gene level and thus to develop atorvastatin response biomarkers for personalized treatment of COPD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    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.
    and
    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 or severe COPD exacerbations, or at least one leading to hospitalization or ICU admission within 12 months, proceeding screening visit.
    Current or ex-smokers who have a smoking history of at least 10 pack years [only use of e-cigarettes or IQOS tobacco heating system cannot be use as a equivalent of classic cigarettes smoking].
    E.4Principal exclusion criteria
    1. Contraindication to statin therapy included but not limited to: known poliomyelitis, motor neuron disease, cranial or temporal arteritis, stroke or myopathy.
    2. Statin use within the last 3 months prior to study start.
    3. Prior diagnosis of statin induced myopathy or hypersensitivity reaction to another HMG-CoA-reductase inhibitor.
    4. CPK levels significantly elevated (> 5 times ULN).
    5. Using e-cigarettes or IQOS tobacco heating system.
    6. Pregnant or nursing (lactating) women.
    7. Women of child bearing potential, unless they are using effective method of contraception during dosing of study treatment.
    8. Patient with a clinically significant abnormality at visit 1 in investigator opinion.
    9. Patients with a clinically relevant laboratory abnormality at visit 1 in investigator opinion.
    10. Subject has known active malignancy of any organ system, i.e., clinical evidence of current malignancy or not in stable remission for at least 5 years since completion of last treatment with exception of non-invasive basal cell carcinoma, squamous cell carcinoma of the skin or cervical intraepithelial neoplasia.
    11. Patients unable to perform acceptable spirometry and lung volumes procedures.
    12. 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.
    13. Patients who have had a respiratory tract infection within 4 weeks prior to visit 1.
    14. Patients requiring oxygen therapy (>15hr/day) on a daily basis for chronic hypoxemia.
    15. Patients with a history of asthma or onset of symptoms prior to age 40 years.
    16. Patients with concomitant pulmonary disease (e.g. lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, tuberculosis).
    17. Patients with primary bronchiectasis.
    18. Patients with a diagnosis of α-1 antitrypsin deficiency (AATD).
    19. Patients with pulmonary lobectomy or lung volume reduction surgery or lung transplantation.
    20. Active abuse of drugs or alcohol, poor compliance anticipated.
    21. 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.
    22. Patients participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the study.
    23. Use of other investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening visit.
    24. Those unable in the opinion of the Investigator to comply fully with the study requirements.
    E.5 End points
    E.5.1Primary end point(s)
    1. Exacerbation rate.
    2. Time to exacerbation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The time points of evaluation will be Follow up 6, 12, 26, 38, 52 weeks after randomisation.
    E.5.2Secondary end point(s)
    1. Duration of exacerbation
    2. Changes in forced expiratory volume in the first second (FEV1)
    3. Changes in health-related quality of life (SGRQ score)
    4. Changes in inflammatory pathway gene expression in the peripheral blood leukocytes (PBLs) by RNA-seq analysis
    5. Changes in blood inflammatory markers (Peripheral blood leucocyte count, fibrinogen, Interleukin-6, high sensitivity C – reactive protein)

    Other secondary endpoints of clinical part include:
    1. Changes from baseline in pre-dose values of plethysmography (functional residual volume (FRC), inspiratory capacity (IC), transfer factor of the lung for carbon monoxide (DLCO)
    2. 6 minute walking distance (6MWD) and the rate of hospitalizations
    3. Changes in vital signs ( blood pressure, HR), and/or laboratory findings.
    4. The rate of hospitalization (pulmonary or MACE)
    E.5.2.1Timepoint(s) of evaluation of this end point
    The time points of evaluation will be Follow up 6, 12, 26, 38, 52 weeks after randomisation.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned12
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 165
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 165
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state480
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 480
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After end of study patients will be treated according to standard of care.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-28
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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