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    Summary
    EudraCT Number:2015-005550-35
    Sponsor's Protocol Code Number:CCD-06001AA1-10
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-07-15
    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 number2015-005550-35
    A.3Full title of the trial
    A RANDOMISED, DOUBLE-BLIND, PLACEBO CONTROLLED, REPEATED DOSE, THREE-WAY CROSSOVER STUDY TO EVALUATE THE PHARMACODYNAMICS, PHARMACOKINETICS AND SAFETY OF TWO DOSES OF CHF 6001 DPI IN SUBJECTS WITH MODERATE, SEVERE COPD.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to evaluate the evolution of a new medicine, CHF 6001 DPI in patients with chronic lung obstruction
    A.4.1Sponsor's protocol code numberCCD-06001AA1-10
    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.5.4Telephone number+39 0521 1689215
    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 nameCHF 6001 400µg/10 mg NEXThaler® DPI
    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.3.9.1CAS number NA
    D.3.9.2Current sponsor codeCHF 6001
    D.3.9.3Other descriptive nameCHF 6001
    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.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
    COPD
    E.1.1.1Medical condition in easily understood language
    difficulty in breathing
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.2System Organ Class 100000004855
    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 effect of CHF 6001 on biomarkers of inflammation in induced sputum and in blood
    E.2.2Secondary objectives of the trial
    To evaluate the effect of CHF 6001 on biomarkers of inflammation on pulmonary function and on symptoms benefits in comparison with placebo
    To evaluate the safety and tolerability of CHF 6001
    To assess the pharmacokinetics profile of CHF 6001 and its metabolites at steady state in subjects with moderate, severe COPD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female aged ≥ 40 years
    2. A female is eligible to enter the study if she is of non-childbearing potential i.e. physiologically incapable of becoming pregnant
    3. Subjects with an established diagnosis of COPD (according to GOLD guidelines, update 2015) at least 12 months prior to the screening visit
    4. With a smoking history of at least 10 pack-years [pack-years=number of cigarettes per day x number of years/20]. Current and ex- smokers are eligible. (Smoking cessation must be at least 3 months prior to the screening.
    5. With a BMI in the range of 18-35 Kg/m2
    6. With a post- bronchodilator FEV1 ≥ 30% and ≤ 70% of the subject normal predicted value and a post-bronchodilator FEV1/FVC ratio <0.70 measured 10-15 minutes after 400µg (4 puffs x 100µg) of salbutamol pMDI. If this criterion is not met at screening, the test can be repeated once before randomisation visit.
    7. Subjects must be receiving daily maintenance with triple therapy (ICS plus LABA plus LAMA) at stable dose and dosing regimen, for at least 2 months prior to screening
    8. With 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’ subject
    9. At screening, subjects must be able to produce an adequate induced sputum sample defined as a load of at least 300 mg with a viability factor of not less than 70% (with less than 30% epithelial cells) and a neutrophil % differential count of at least 60%.
    10. Subjects must be symptomatic at screening defined as having a CAT score ≥10

    E.4Principal exclusion criteria
    1. Pregnant or lactating female subject
    2. Subjects with a current diagnosis of asthma
    3. Subjects with a moderate or severe COPD exacerbation [i.e. resulting in the use of systemic (oral/IV/IM corticosteroids) and/or antibiotics or in hospitalisation] or a lower respiratory tract infection within 6 weeks prior to study entry or during the screening period
    4. Subjects on maintenance bronchodilators therapy only (LABA alone, LAMA alone, dual LABA/LAMA alone) or maintenance dual therapy only (ICS/LABA or ICS plus LAMA) within 2 months prior to study entry
    5. Subjects on PDE4 inhibitors (e.g. roflumilast) within 2 months prior to study entry
    6. Subjects requiring long-term (at least 12 hours daily) oxygen therapy for chronic hypoxemia
    7. Subjects participating to a pulmonary rehabilitation programme or completing such a programme within the last 6 weeks prior to study entry
    8. Subjects with known respiratory disorders other than COPD that in investigator’s opinion would affect efficacy and safety evaluation or place the subject at risk. This can include but is not limited to known alpha-1 antitrypsin deficiency, active tuberculosis, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial lung disease
    9. Subjects with active (lung) cancer or a history of lung cancer ;or a history of cancer other than lung cancer with less than 5 years disease free survival time (whether or not there is evidence of local recurrence or metastases). Localized carcinoma (e.g. basal cell carcinoma (without metastases), in situ carcinoma of the cervix adequately treated,) is acceptable
    10. Subjects with a known history of hypersensitivity to β2-agonist, PDE4 inhibitors or any of the excipients contained in any of the formulations used in the trial
    11. Subjects who have known history of clinically significant cardiovascular conditions such as, but not limited to, unstable or acute ischemic heart disease within one year prior to study entry, NYHA Class III/IV heart failure, known history of sustained and non-sustained cardiac arrhythmias or history of atrial fibrillation diagnosed in the last 6 months prior to study entry and not controlled with therapy rate control strategy as well as subjects with a history or symptoms of significant neurological disease including transient ischemic attack (TIA), stroke, seizure disorder or behavioural disturbances
    12. Male subjects with a QTcF >450 ms and female subjects with a QTcF >470 ms at screening and/or at randomisation visits
    13. Subjects who have unstable concurrent disease: e.g. uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; significant hepatic impairment, significant renal impairment; history of cerebrovascular disease; uncontrolled gastrointestinal disease (e.g. active peptic ulcer, Crohn’s disease, ulcerative colitis, enteritis, unexplained diarrhea, bloody or loose stools); uncontrolled haematological disease; uncontrolled autoimmune disorders (e.g. rheumatoid arthritis, inflammatory bowel disease) or other disease or condition that might, in the judgement of the investigator , place the subject at undue risk or potentially compromise the results or interpretation of the study
    14. Subjects with abnormal alanine aminotransferase (ALT) ≥2x upper limit of normal (ULN) and/ or aspartate aminotransferase (AST) ≥2x ULN and/or bilirubin ≥1.5x ULN. Isolated bilirubin ≥1.5x ULN is acceptable if fractionated and direct bilirubin is <35%
    15. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones)
    16. Subjects receiving treatment with any drug known to have a well-defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole) within the previous 3 months prior to the study entry
    17. Subjects have experienced excessive weight loss recently (which cannot be explained by the natural course of COPD or known background conditions).
    18. Subjects with a history of alcohol abuse and/or substance/drug abuse within 12 months prior to screening visit
    19. Subjects having received any other investigational drug within the preceding 30 days (60 days for biologics), or a longer and more appropriate time as determined by the Investigator (e.g., approximately five half-lives of the previous investigational drug).
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokinetic: Plasma: AUC0-12h,ss, Cmin,ss, Cmax,ss, Cav,ss, tmax,ss, tmin,ss,CL/Fss (for CHF 6001 only), calculated from the individual 0-12h plasma concentration time
    profiles of CHF 6001 and its main metabolites CHF 5956 and CHF 6095 on
    Day 32 at steady state.
    sputum cell count and biomarkers
    E.5.1.1Timepoint(s) of evaluation of this end point
    on Day 32 at steady state
    E.5.2Secondary end point(s)
    1/ blood biomarkers
    2/ lung function
    3/ TDI, CAT scores
    4/ PK parameters
    5/ Safety (AEs, ADRs, vital signs)
    E.5.2.1Timepoint(s) of evaluation of this end point
    on day 32, except for AE ADR
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) 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 No
    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) 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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 years
    E.8.9.1In the Member State concerned months9
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    see protocol
    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 Decision2016-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-26
    P. End of Trial
    P.End of Trial StatusOngoing
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