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    Summary
    EudraCT Number:2012-001005-25
    Sponsor's Protocol Code Number:CCD-1201-PR-0079
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-06-11
    Trial results View 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 ConcernedUK - MHRA
    A.2EudraCT number2012-001005-25
    A.3Full title of the trial
    A randomised, double-blind, double-dummy, placebo and active-controlled, three-way crossover study to evaluate the safety, tolerability and efficacy of 28-day inhaled CHF 6001 DPI (1200microgrammes daily) in subjects with COPD
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to look at the safety, effectiveness and how COPD patients tolerate a new compound CHF6001 which will be inhaled daily for 28 days compared with existing treatment and placebo
    A.4.1Sponsor's protocol code numberCCD-1201-PR-0079
    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 pointOriana Esposito
    B.5.3 Address:
    B.5.3.1Street AddressVia Palermo 26/A
    B.5.3.2Town/ city Parma
    B.5.3.3Post code43122
    B.5.3.4CountryItaly
    B.5.4Telephone number3905211689204
    B.5.5Fax number390521279333
    B.5.6E-mailo.esposito@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 nameCHF 6001 DPI
    D.3.2Product code CHF 6001 DPI
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    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 INNNA
    D.3.9.2Current sponsor codeCHF 6001
    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 RoleComparator
    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 DAXAS
    D.2.1.1.2Name of the Marketing Authorisation holderNycomed GmBH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameDAXAS
    D.3.4Pharmaceutical form 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 INNroflumilast
    D.3.9.1CAS number 162401-32-3
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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, hard capsule
    D.8.4Route of administration of the placeboInhalation use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    The participants of this study have chronic obstructive pulmonary disease (COPD).
    E.1.1.1Medical condition in easily understood language
    Participants with COPD have difficulty breathing
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    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 objectives of the study are:
    - to evaluate the effect of CHF 6001 DPI on biological markers of inflammation in induced sputum and in the blood, and on pulmonary function.
    - to evaluate the safety and tolerability of CHF 6001 DPI after 28 days of inhaled dosing
    - to assess the blood PK profile of CHF6001 and its metabolite at steady-state in GOLD stage 2-3 COPD patients

    E.2.2Secondary objectives of the trial
    This is an exploratory study therefore the objectives have not been identified as either primary or secondary
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent obtained prior to any study-related procedures.
    2. Male or female aged between 40 and 70 years inclusive.
    3. Current or past smoker of at least 10 pack/years. (If the subjects undergo smoking cessation therapy, it must be completed 3 months prior to the screening visit and smoking status should not change between the subjects screening visit and subjects last study visit).
    4. BMI in the range of 18-35 Kg/m2.
    5. A cooperative attitude and ability to be trained on the proper use of the Aerolizer inhaler, and to perform spirometry testing.
    6. Subject must be able, in the Investigator’s opinion, to discontinue xanthines, antileukotrienes, cromoglycates, long acting (or nebulised) β2-agonists, inhaled corticosteroids (ICS), oral and/or systemic corticosteroids and roflumilast, if already receiving these. They must remain stable, according to the Investigator’s judgement, on inhaled tiotropium 18µg daily with PRN salbutamol.
    • Xanthine derivatives, antileukotrienes, cromoglycates and roflumilast must be discontinued at least 4 weeks prior to Day 1 of the first study Period (i.e. 2 weeks prior to the screening visit).
    • ICS, LABA, oral and/or nebulised β agonists must be discontinued at least 2 weeks prior to Day 1 of the first study Period (i.e. 12h prior to the screening visit).
    • Oral and/or systemic corticosteroids must not be taken within 6 weeks prior to the screening visit
    7. In the Investigator’s opinion subjects should be able to withhold tiotropium 24h prior to the screening visit.
    8. GOLD Stage 2 and 3 COPD subjects as defined by the GOLD guidelines with a post- bronchodilator FEV1 between 40-80% of the predicted value and a ratio FEV1/FVC <0.70.
    9. A history of chronic bronchitis defined as chronic cough and sputum production for more than three months per year for two or more years and known as ‘spontaneous sputum producer’.
    10. At screening, subjects must be able to produce an adequate induced sputum sample defined as a load of at least 75mg with a viability factor of not less than 40%, (with ideally less than 30 % epithelial cells). The subjects may be re-challenged by induction at least 48 hours later, if the first sputum sample did not meet these criteria. The re-challenge can be repeated until an adequate sputum sample is produced (at least 48 hours between attempts must be allowed). The subject will enter the Run-in Period only after an adequate sputum sample is produced.
    11. At screening. subjects must be able to be trained to use the devices correctly and to generate sufficient PIF (at least 60 L/min) using the In-Check Dial® device.
    12. Male subjects: they and/or their partner must be willing to use a reliable method of contraception from the time of dose administration and until 90 days after the last dose of study drug. Subjects must not donate sperm for 90 days after the last dose of study drug.
    13. Female subjects: post-menopausal women having at least 12 months of natural (spontaneous) amenorrhea, or women of childbearing potential (defined as all women physiologically capable of becoming pregnant, using an acceptable method of contraception).
    E.4Principal exclusion criteria
    1. Pregnant or lactating women,
    2. Past or current history of asthma.
    3. History of clinically significant hypotensive episodes or symptoms of fainting, dizziness, or light-headedness.
    4. History or symptoms of significant cardiovascular disease, particularly coronary artery disease, arrhythmias, or congestive heart failure.
    5. History or symptoms of significant neurological disease including transient ischemic attack (TIA), stroke, seizure disorder or behavioural disturbances.
    6. Unstable concurrent disease which could interfere with the conduct of the study, or for which the treatment might interfere with the conduct of the study, or which would in the opinion of the Investigator pose an unacceptable risk to the subject in this study.
    7. An abnormal and clinically significant 12-lead ECG that results in an active medical problem, as defined by the Investigator, or an electrocardiogram (12-lead ECG) with QTcF > 450 ms for males or QTcF > 470 ms for females.
    8. Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation.
    9. A worsening of COPD or a lower respiratory tract infection requiring use of oral or systemic corticosteroids, oral and/or nebulised β2 agonists and/or antibiotics within 6 weeks preceding the screening visit.
    10. The need for chronic use of any other medication for treatment of lung disease like xanthines, antileukotrienes, systemic and inhaled corticosteroids, long acting β2-agonists, roflumilast (other than the study drug) and cromoglycates during the study Period.
    11. Current participation in a pulmonary rehabilitation programme or completion of such a programme within the last 6 weeks.
    12. Subjects requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxaemia.
    13. Subjects having received any other investigational drug within the preceding 30 days, or a longer and more appropriate time as determined by the Investigator (e.g., approximately five half-lives of the previous investigational drug).
    14. Blood draws of 250 mL or more within 45 days prior to enrolment into the study.
    15. Known respiratory disorders other than COPD including but not limited to asthma, α-1 antitrypsin deficiency, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial lung disease.
    16. Recent (less than 1 year) history of alcohol dependency, or substance abuse that in the opinion of the Investigator may be of clinical significance.
    17. Unwillingness or inability to comply with the study Protocol for any other reason.
    E.5 End points
    E.5.1Primary end point(s)
    This is an exploratory study therefore the objectives and the endpoints have not been identified as either primary or secondary
    The primary objectives of the study are:
    - to evaluate the effect of CHF 6001 DPI on biological markers of inflammation in induced sputum and in the blood, and on pulmonary function.
    - to evaluate the safety and tolerability of CHF 6001 DPI after 28 days of inhaled dosing
    - to assess the blood PK profile of CHF6001 and its metabolite at steady-state in GOLD stage 2-3 COPD patients
    E.5.1.1Timepoint(s) of evaluation of this end point
    Biomarkers - Sputum Days 21, 24, 28
    Blood day 28
    Pulmonary Function days 9, 21, 24, 28
    PK Paramaters -Day 28
    Safety & Tolerability - Day 28
    PK profile - Day 28
    E.5.2Secondary end point(s)
    There is no secondary endpoint
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    tolerability
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 concerned5
    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 - Last visit last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months12
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 52
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    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 state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 65
    F.4.2.2In the whole clinical trial 65
    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)
    Participants will resume their routine medication after the follow-up on Day 29 of treatment period 3.

    The study drug will not be made available after the end of the study.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-08-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-10-21
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