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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41229   clinical trials with a EudraCT protocol, of which   6756   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2011-003588-31
    Sponsor's Protocol Code Number:CCD-1106-PR-0066
    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:2011-11-25
    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 number2011-003588-31
    A.3Full title of the trial
    A multicentre, randomised, double-blind, active-controlled, 4-way cross-over study to evaluate the efficacy and safety of a free combination of 3 doses of Glycopyrrolate with fixed combination Beclomethasone Diproprionate plus Formoterol (Foster®) in a metered dose inhaler for the treatment of patients with Chronic Obstructive Pumlonary Disease (COPD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to assess the most efficacious dose of bronchodilator, Glycopyrrolate, to add to the existing treatment (Foster®, Beclomethasone + Formoterol) for the development of a new triple therapy in a single aerosol for the treatment of patients suffering from severe COPD.
    A.4.1Sponsor's protocol code numberCCD-1106-PR-0066
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01476813
    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 pointGéraldine Cohuet
    B.5.3 Address:
    B.5.3.1Street AddressVia Palermo 26/A
    B.5.3.2Town/ cityParma
    B.5.3.3Post code41322
    B.5.3.4CountryItaly
    B.5.4Telephone number+33147 68 41 46
    B.5.5Fax number+33147 68 49 04
    B.5.6E-mailg.cohuet@chiesifrance.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 nameGlycopyrrolate
    D.3.2Product code CHF 5259
    D.3.4Pharmaceutical form Pressurised inhalation, solution
    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 INNGlycopyrrolate bromide
    D.3.9.1CAS number 596-51-0
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number12.5 to 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.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 Foster 100/6µg
    D.2.1.1.2Name of the Marketing Authorisation holderChiesi Pharmaceuticals GmbH
    D.2.1.2Country which granted the Marketing AuthorisationSlovakia
    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 nameFoster 100/6µg
    D.3.4Pharmaceutical form Pressurised inhalation, solution
    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 INNBECLOMETASONE DIPROPIONATE
    D.3.9.1CAS number 5534-09-8
    D.3.9.4EV Substance CodeSUB00681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFORMOTEROL FUMARATE
    D.3.9.1CAS number 43229-80-7
    D.3.9.2Current sponsor codeCHF 1535
    D.3.9.4EV Substance CodeSUB02257MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 placeboPressurised inhalation, solution
    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
    E.1.1.1Medical condition in easily understood language
    COPD, or chronic obstructive pulmonary disease, is a progressive disease that makes it hard to breathe. "Progressive" means the disease gets worse over time.
    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 14.1
    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
    To evaluate the efficacy of a free combination of glycopyrrolate at 3 dose levels with fixed combination beclomethasone dipropionate plus formoterol (Foster®) in a metered dose inhaler by comparison with Foster in terms of FEV1 AUC0-12h normalized by time on Day 7.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of the free combination glycopyrrolate + Foster on other lung function parameters and on clinical outcome measures. To assess the safety and the tolerability of the study treatments.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female adults (40 ≤ age ≤ 80 years) with written informed consent obtained prior to any study-related procedure.
    2. Outpatients with a diagnosis of COPD (according to GOLD guidelines) 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 therapy must be completed within 3 months prior to screening visit and smoking status shall not change after screening and during the study period)
    - A Post-bronchodilator 30%≤FEV1<60% of the predicted normal value
    - A Post-bronchodilator FEV1/FVC < 0.7
    - An increase from baseline of FEV1 value 30 min after 80µg ipratropium of at least 60mL
    3. Patients treated with double therapy with inhaled corticosteroids/long-acting β-agonist combination or with triple therapy with inhaled corticosteroids/long-acting β-agonist combination and long-acting anticholinergic (tiotropium) if taken for not more than one month at stable regimen before screening.
    4. A cooperative attitude and ability to be trained to use correctly the pMDI inhalers.
    E.4Principal exclusion criteria
    1.Pregnant or lactating women.
    In case of childbearing potential, patients and/or their partner must be willing to use an approved method of contraception unless they meet the post-menopausal definition (amenorrhea>12 Mo or >6 Mo with FSH >40 mIU/ml). Methods of contraception may include one or more of the following ones: Surgical sterilization, hormonal contraception, double-barrier methods and periodic abstinence
    Reliable contraception should be maintained throughout the study.
    2.Diagnosis of asthma or history of allergic rhinitis or atopy.
    3.Participation in another clinical trial where investigation drug was received less than 8 weeks prior to first intake of the study medication.
    4.Hospitalisation for COPD or pneumonia within 3 month prior to screening
    5.Patients experiencing a COPD exacerbation requiring use of systemic steroids and/or antibiotics in the 4 weeks prior to screening and during the run-in period.
    6.Patients treated with oral/parenteral β2-agonists or nebulised bronchodilators or PDE inhibitors in the 4 weeks prior to screening and during the run-in period.
    7.Use of antibiotics for a lower respiratory tract infection in the 4 weeks prior to screening and during the run-in period.
    8.Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia.
    9.Known respiratory disorders other than COPD including but not limited to alpha-1 antitrypsin deficiency, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial lung disease.
    10.Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the investigator would prevent use of anticholinergic.
    11.History of hypersensitivity to M3 Antagonists, β2-agonist, corticosteroids or any of the excipients contained in any of the formulations used in the trial.
    12.History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening visit
    13.An abnormal and clinically significant 12-lead ECG that results in active medical problem.
    14.Electrocardiogram (ECG) (12 lead) with QTcF >450 ms for males or QTcF > 470 ms for females.
    15.Clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease which may impact the feasibility of the results of the study according to investigator’s judgement.
    16.Patients with serum potassium levels < 3.5 mEq/L (or 3.5 mmol/L).
    17.Unstable concurrent disease: e.g. uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; cardiovascular disease (e.g. uncontrolled coronary artery disease, uncontrolled hypertension); uncontrolled gastrointestinal disease (e.g. active peptic ulcer); neurological disease; uncontrolled haematological disease; uncontrolled autoimmune disorders, or other which may impact the feasibility of the results of the study according to investigator’s judgment.
    18.Evidence of heart failure (NYHA class IV).
    19.Changes in dose, schedule, formulation or product of oral xanthine derivatives (eg theophylline) in the three months prior to screening visit.
    20.Change in dose, schedule, formulation or product of β-blockers in the month prior to screening.
    E.5 End points
    E.5.1Primary end point(s)
    FEV1 AUC0-12h normalized by time on Day 7
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 7
    E.5.2Secondary end point(s)
    Efficacy variables:
    •Trough FEV1, FVC and IC at 12 h on Day 1 and Day 7 (mean of the two measurements at 12h and 12.5h post-dose)
    •Trough FEV1, FVC and IC at 24h (mean of the two measurements at 23.5h and 24h post-dose) on Day 7 (i.e. on the morning of Day 8)
    •FEV1 AUC0-12h normalised by time on Day 1
    •FEV1 AUC0-24h and AUC12-24h normalised by time on Day 7
    •Peak FEV1, FVC and IC on Day 1 and Day 7
    •FEV1, FVC and IC at each time point on Day 1 and Day 7
    •Transition Dyspnoea Index (TDI) score on Day 8
    •Average use of rescue medication (number of puffs/day) during the treatment period
    •Percentage of rescue use-free days during the treatment period

    Safety variables:
    •Adverse events and adverse drug reactions
    •Vital signs (systolic and diastolic blood pressure, heart rate)
    •Standard haematology and blood chemistry
    •12-lead ECG
    E.5.2.1Timepoint(s) of evaluation of this end point
    Days 1, 7 and 8
    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) 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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    Russian Federation
    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 years0
    E.8.9.1In the Member State concerned months9
    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 months9
    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.1.1.1In 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: 72
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 108
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    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)
    Expected normal treatment of the 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 Decision2012-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-09-28
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