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    Summary
    EudraCT Number:2020-003666-40
    Sponsor's Protocol Code Number:CLI-06001AA1-04
    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:2021-11-04
    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 number2020-003666-40
    A.3Full title of the trial
    A 52-week, randomized, double-blind, placebo-controlled, parallel-group, study to evaluate the efficacy and safety of two doses of CHF6001 DPI add-on to maintenance triple therapy in subjects with Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The efficacy and the safety of two doses of CHF6001 for the treatment of Chronic Obstructive Pulmonary Disease (COPD).
    A.3.2Name or abbreviated title of the trial where available
    PILASTER
    A.4.1Sponsor's protocol code numberCLI-06001AA1-04
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04636801
    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 SponsorChiesi Farmaceutici S.p.A.
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportChiesi Farmaceutici S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChiesi Farmaceutici S.p.A.
    B.5.2Functional name of contact pointCLINICAL PROJECT MANAGER
    B.5.3 Address:
    B.5.3.1Street AddressVia Palermo 26/A
    B.5.3.2Town/ cityParma
    B.5.3.3Post code43122
    B.5.3.4CountryItaly
    B.5.6E-mailclinicaltrials_info@chiesi.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 No
    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.3.1Product nameCHF6001 NEXThaler 400 μg/20 mg
    D.3.2Product code CHF6001
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTanimilast
    D.3.9.1CAS number 1239278-59-1
    D.3.9.2Current sponsor codeCHF 6001
    D.3.9.3Other descriptive nameCHF 6001.00
    D.3.9.4EV Substance CodeSUB180242
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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.IMP: 2
    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 No
    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.3.1Product nameCHF6001 NEXThaler 800 μg/20 mg
    D.3.2Product code CHF6001
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTanimilast
    D.3.9.1CAS number 1239278-59-1
    D.3.9.2Current sponsor codeCHF 6001
    D.3.9.3Other descriptive nameCHF 6001.00
    D.3.9.4EV Substance CodeSUB180242
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    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 placeboInhalation powder
    D.8.4Route of administration of the placeboInhalation 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) and Chronic Bronchitis
    E.1.1.1Medical condition in easily understood language
    Chronic Obstructive Pulmonary Disease (COPD)
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    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
    To evaluate the efficacy of two doses of CHF6001 add-on to maintenance triple therapy (ICS, LABA, LAMA) to reduce the rate of moderate and severe exacerbations after 52 weeks of treatment in comparison with maintenance triple therapy (i.e. placebo arm).
    E.2.2Secondary objectives of the trial
    To evaluate
    -the efficacy of the two doses of CHF6001 add-on to maintenance triple therapy on health related quality of life after 52 weeks of
    treatment (change in SGRQ total score).
    -the efficacy of the two doses of CHF6001 add-on to maintenance triple therapy on lung function, health-related quality of life, severe exacerbations in the pooled analysis of CLI-06001AA1-04 Main cohort (excluding subjects enrolled in China) and CLI-06001AA1-05 studies and other clinical outcome measures in comparison with maintenance triple therapy
    -the safety and tolerability of the two doses of CHF6001
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetic variables
    A subset of about 240 randomized subjects (80 expected in each treatment group) will be selected in order to reach about 60 evaluable subjects for each CHF6001 dose treatment. PK parameters will be estimated by measurement of CHF6001 plasma levels in a subset of subjects at different timepoints (pre-dose and over 8 hours post-dose) on V2 (Day 0) and V5 (week 26) and at pre-dose only on V4 (week12) and V6 (week 40).
    Exclusion criteria for the subset of subjects undergoing PK assessments
    1. Subjects with unsuitable veins for repeated venopuncture.
    2. Blood donation (excluding plasma donations) or blood loss equal or more than 450 mL less than 2 months prior to screening
    E.3Principal inclusion criteria
    1.Males and females aged ≥ 40 years with written informed consent obtained prior to any study-related procedure.
    2.Females are eligible to enter the study if they are of
    a.non-childbearing potential
    or
    b.childbearing potential, they must have a negative pregnancy test at screening and must agree to use one or more of the acceptable contraceptive measures.
    3.Subjects with an established diagnosis of COPD with chronic bronchitis
    4.Current smokers or ex-smokers who quit smoking at least 6 months prior to screening visit, with a smoking history of at least 10 pack years.
    5.A post-bronchodilator FEV1 < 60% of the subject predicted normal value and a post-bronchodilator FEV1/FVC ratio < 0.7 after 400µg (4 puffs x 100µg) of salbutamol pMDI or equivalent dose of albuterol pMDI in the US.
    6.A documented history (e.g. medical record verification) of at least one moderate or severe COPD exacerbation in previous year.
    7.Symptomatic subject at screening defined as having a CAT score ≥
    8.Subjects prescribed with maintenance triple therapy (free or fixed combination of ICS, LABA, LAMA) according to GOLD 2020 recommendations for at least 12 months prior to screening and receiving regular maintenance triple therapy for at least 3 months prior to the Screening visit.
    9.Subjects are willing and able to be trained to use correctly the DPI inhalers (NEXThaler®).
    10.Subjects are willing and able to be trained to use correctly the electronic devices with COPD questionnaires, to understand and to perform required outcome measurements of the protocol (e.g. spirometry manoeuvres etc.) and ability to understand the risks involved.
    E.4Principal exclusion criteria
    1.Subjects with a diagnosis of current asthma.
    2.Subjects with a moderate or severe COPD exacerbation 4 weeks prior to study entry and during run-in period.
    3..Pregnant and lactating women.
    4.Subjects requiring long term (at least 15 hours daily) oxygen therapy for chronic hypoxemia.
    5.Subjects with known α-1 antitrypsin deficiency as the underlying cause of COPD
    6.Subjects with primary diagnosis of emphysema not related to COPD.
    7.Subjects with clinically significant respiratory disorders other than COPD.
    8.Subjects with lung volume reduction surgery.
    9.Subjects having lung cancer or a history of lung cancer with full recovery less than 1 year after completing cancer therapy
    10.Subjects with active cancer or a history of cancer (other than the lung) with full recovery less than 1 year after completing cancer therapy or any untreated localized carcinoma
    11.Subjects with a history of allergy or hypersensitivity to anticholinergics, β2-agonists, corticosteroids, PDE-4 inhibitors or any of the excipients contained in any of the formulations used in the trial or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the investigator’s opinion would contra-indicate study participation.
    12.Subjects under Roflumilast treatment within 6 months before study entry
    13.Subjects with a diagnosis of depression, generalised anxiety disorder, suicidal ideation or behaviour that might, according to the investigator judgement, place the subject at undue risk.
    14.Subjects who have clinically significant cardiovascular condition.
    15.An abnormal and clinically significant 12-lead ECG finding in relation to the subject’s medical history that results in active medical problem which may impact the safety of the subject according to investigator’s judgement.
    16.Subjects with a significant neurological disease including transient ischemic attack (TIA), stroke, seizure disorder or behavioural disturbances that in investigator’s opinion, would place the subject at risk by participating to the study.
    For complete list of exclusion criteria, please refer to the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Annual rate of moderate and severe exacerbations over 52 weeks
    E.5.1.1Timepoint(s) of evaluation of this end point
    Over 52 weeks
    E.5.2Secondary end point(s)
    •Change from baseline in SGRQ Total score at week 52
    •Time to first moderate/severe exacerbation
    •Annual rate of severe exacerbations
    •Time to first severe exacerbation
    •The number of on-treatment severe exacerbations
    •Change from baseline in morning pre-dose of FEV1 at week 52
    •Change from baseline in SGRQ Domain scores at week 52
    •SGRQ response (i.e., change from baseline in SGRQ score ≥ -4) at week 52
    •Change from baseline to last inter-visit period (week 40-52) in the average E-RS total and sub-scale scores
    •E-RS response (i.e., change from baseline in E-RS total score ≤ -2) at week 52
    •Change from baseline to last inter-visit period (week 40-52) in the percentage of days without intake of rescue medication and in the average daily use of rescue medication (number of puffs)
    •Time to study medication discontinuation due to any reason
    •Time to first moderate or severe exacerbation or study medication discontinuation (due to any adverse events, lack of efficacy or death (composite endpoint) and time to its individual components (i.e. time to study medication discontinuation).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Over 52 weeks
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 trial3
    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 concerned24
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA174
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Chile
    New Zealand
    Ukraine
    China
    Israel
    Mexico
    Russian Federation
    South Africa
    United Kingdom
    Austria
    Bulgaria
    Czechia
    France
    Germany
    Greece
    Hungary
    Italy
    Netherlands
    Poland
    Romania
    Slovakia
    Spain
    Türkiye
    E.8.7Trial has a data monitoring committee Yes
    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 years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days3
    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: 1985
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1000
    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 state410
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1618
    F.4.2.2In the whole clinical trial 2985
    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)
    NONE
    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 Decision2021-05-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-13
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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