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    The EU Clinical Trials Register currently displays   41200   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-000558-40
    Sponsor's Protocol Code Number:CCD-06302AA1-01
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-12-29
    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 ConcernedGermany - BfArM
    A.2EudraCT number2015-000558-40
    A.3Full title of the trial
    A multicenter, randomised, double blind, placebo-controlled, incomplete block, 3-way cross-over study to evaluate the efficacy and safety of 4 doses of glycopyrronium bromide DPI in moderate to severe patients with chronic obstructive pulmonary disease (COPD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Research study to evaluate the effect of different doses of inhaled glycopyrronium bromide via Nexthaler in COPD patients
    A.4.1Sponsor's protocol code numberCCD-06302AA1-01
    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+33147684135
    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 nameGlycopyrronium bromide 25µg NEXThaler
    D.3.2Product code CHF 5259
    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 INNGLYCOPYRRONIUM BROMIDE
    D.3.9.1CAS number 596-51-0
    D.3.9.2Current sponsor codeCHF5259.02
    D.3.9.3Other descriptive nameGlycopyrrolate
    D.3.9.4EV Substance CodeSUB07951MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 nameGlycopyrronium bromide 12.5µg NEXThaler
    D.3.2Product code CHF 5259
    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 INNGLYCOPYRRONIUM BROMIDE
    D.3.9.1CAS number 596-51-0
    D.3.9.2Current sponsor codeCHF5259.02
    D.3.9.3Other descriptive nameglycopyrrolate
    D.3.9.4EV Substance CodeSUB07951MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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: 3
    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 nameGlycopyrronium bromide 6.25µg NEXThaler
    D.3.2Product code CHF 5259
    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 INNGLYCOPYRRONIUM BROMIDE
    D.3.9.1CAS number 596-51-0
    D.3.9.2Current sponsor codeCHF5259.02
    D.3.9.3Other descriptive nameglycopyrrolate
    D.3.9.4EV Substance CodeSUB07951MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.25
    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)
    E.1.1.1Medical condition in easily understood language
    Breathing difficulties due to narrowing of the airways.
    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 18.1
    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 is to identify the optimal dose of CHF 5259 glycopyrronium bromide (GB) to be further developed for the treatment of patients with COPD.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of CHF 5259 glycopyrronium bromide (GB) on lung function parameters.
    To assess the safety of the study treatments.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients aged ≥ 40 years at screening visit, who have
    signed an Informed Consent form prior to initiation of any study-related procedure.
    2. Patients with a diagnosis of COPD (according to GOLD guidelines 2015) at least 12 months before screening visit.
    3. Current smoker or ex-smoker with a smoking history of at least 10 pack-years defined as
    [(number of cigarettes smoked per day) × (number of years of smoking)] / 20. (If the subjects undergo smoking cessation therapy, it must be completed 3 months prior to the screening visit. Smoking cessation must be at least 3 months prior the screening. In both cases the smoking status should not change between the subjects screening visit and subjects last study visit).
    4. A post-bronchodilator FEV1 ≥ 40% and ≤70% of the predicted normal value (measured 30 to 45 minutes after administration of 80 μg ipratropium pMDI) and,
    - a post-bronchodilator FEV1/FVC < 0.7 and, - a change in FEV1 from the pre-bronchodilator value (reversibility) of at least 5% at screening
    If the criterion is not met at screening, the test can be rescheduled once before randomisation.
    5. Patients under bronchodilators with long-acting muscarinic antagonist or long-acting beta-2 agonist (monotherapy or dual therapy), or patients under ICS + LABA or ICS + LAMA for at least 4 weeks prior to screening. (Patients with a FEV1<50% of the predicted value and a history of 1 exacerbation within the last 12 months must have been treated with ICS+LABA or ICS+LAMA before screening)
    6. Ability and cooperative attitude to understand and to perform required outcome measurements of the protocol (e.g. spirometry manoeuvres) and ability to understand the risks involved.
    Ability to be trained to use the DPI inhalers.
    E.4Principal exclusion criteria
    1. Diagnosis of asthma or other respiratory disorders (other than COPD)
    which may interfere with data interpretation according to the investigator's opinion.
    2. Patients had a COPD exacerbation or a lower respiratory tract infection within 8 weeks prior to screening, or during the run-in period, that resulted in the use of an antibiotic, or oral or parenteral corticosteroids, or hospitalisation.
    3. Patients with a history of ≥ 2 exacerbations within the last 12 months prior to screening
    (frequent exacerbators).
    4. Patients treated with oral/parenteral β2-agonists or nebulised bronchodilators or PDE
    inhibitors or who received LABA/LAMA/ICS treatment therapy in the 4 weeks prior to
    screening and during the run-in period.
    5. Patient is on an inhaled corticosteroid that has been initiated, or the effective dose has been changed, within 4 weeks prior to screening or during the run-in period (patients on stable dose of ICS for at least 4 weeks prior to screening are allowed).
    6. Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia.
    7. Patients with known respiratory disorders other than COPD.
    8. Patients with medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the investigator would prevent use of anticholinergic.
    9. Patients who have unstable concurrent disease, that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study;
    10. Patients who have a concomitant disease of poor prognosis
    11. Patients who have clinically significant cardiovascular condition
    12. Patients with known atrial fibrillation (AF):
    a. Paroxysmal Atrial Fibrillation
    b. Persistent: AF episode lasting more than 7 days or requiring termination by
    cardioversion, either with drugs or by direct current cardioversion (DCC) within 6 months prior to screening visit.
    c. Long standing persistent: continuous atrial fibrillation diagnosed for less than 6 months
    and/ or without a rhythm control strategy.
    d. Permanent: AF diagnosed for at least 6 months with a resting ventricular rate ≥ 100/min
    not controlled with a rate control strategy (i.e., selective β-blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy).
    13. Patients have a clinically significant abnormal 12-lead ECG that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study.
    14. Patients whose electrocardiogram 12-lead ECG shows a QTcF>450 ms for males or QTcF > 470 ms for females.
    15. Patients with clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study.
    16. Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS they are willing to use a highly effective birth control methods such as :
    a. Placement of an intrauterine device or intrauterine releasing system
    b. Oral, intravaginal, transdermal combined estrogen and progestogen
    containing hormonal contraception or oral, injectable, implantable progestogen only hormonal contraception.
    c. Bilateral tubal occlusion
    d. Partner vasectomy (provided that partner is the sole sexual partner of the WOCBP
    trial participant and that the vasectomised partner has received medical assessment of
    the surgical success)
    e. sexual abstinence defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments
    Female patients of non-childbearing potential defined as physiologically incapable of becoming pregnant: post-menopausal ( defined as no menses for 12 months without an
    alternative medical cause) or permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy) are eligible.
    17. Patients known to have intolerance/hypersensitivity or any contraindication to treatment with M3 Antagonist or any of the excipients contained in the formulations used in the study.
    18. Patients who have evidence of alcohol or drug abuse, not compliant with the study protocol or not compliant with the study treatments according to investigator's judgment.
    19. Patients with major surgery in the previous 3 months or planned during the trial which may affect patient's compliance in study procedures.
    20. Patients who have participated in another clinical trial with an investigational drug in the 2 months preceding the screening.
    E.5 End points
    E.5.1Primary end point(s)
    FEV1 AUC 0-12h normalised by time
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28
    E.5.2Secondary end point(s)
    EFFICACY VARIABLES:
    FEV1, FVC, Transition Dyspnoea Index (TDI)

    SAFETY VARIABLES:
    Adverse events and adverse drug reactions
    Vital signs, ECG and laboratory
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1, day 14 and/or day 28, and across the study for safety variables
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    incomplete block, 3-way crossover
    E.8.2.4Number of treatment arms in the trial5
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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 years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state31
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 180
    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)
    The investigator will prescribe the more appropriate treatment to the subject corresponding to his medical condition.
    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 Decision2016-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-02-06
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