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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   41232   clinical trials with a EudraCT protocol, of which   6757   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:2010-018668-18
    Sponsor's Protocol Code Number:CCD-0916-PR-0032
    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:2010-06-08
    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 number2010-018668-18
    A.3Full title of the trial
    RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, CROSS-OVER STUDY TO INVESTIGATE THE BRONCHODILATOR EFFICACY AND SAFETY AFTER SINGLE AND REPEATED ADMINISTRATIONS OF DIFFERENT DOSES OF GLYCOPYRROLATE VIA PMDI IN MODERATE TO SEVERE COPD PATIENTS.
    (GLYCO 2)
    A.3.2Name or abbreviated title of the trial where available
    GLY2
    A.4.1Sponsor's protocol code numberCCD-0916-PR-0032
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameGlyco pMDI
    D.3.2Product code CHF 5259 pMDI
    D.3.4Pharmaceutical form Pressurised inhalation, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.9.2Current sponsor codeCHF 5259.02
    D.3.9.3Other descriptive nameGlyco
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.3.9.2Current sponsor codeCHF 5259.02
    D.3.9.3Other descriptive nameGlyco
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Spiriva
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameSpiriva 18 µg inhalation powder, hard capsule
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNTIOTROPIUM BROMIDE
    D.3.9.1CAS number 139404481
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    COPD
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    PART I
    • To assess the safety and tolerability of single administration of Glyco pMDI at 5 dose levels in patients with moderate to severe COPD

    PART II
    • To assess the bronchodilator efficacy of Glyco pMDI at 3 dose levels by comparison with placebo in patients with moderate to severe COPD after repeated administration
    E.2.2Secondary objectives of the trial
    PART I
    • To assess the bronchodilator efficacy of single administration of Glyco pMDI at 5 dose levels by comparison with placebo in patients with moderate to severe COPD.

    PART II
    • To evaluate the duration of bronchodilation
    • To assess the safety and tolerability of repeated doses of Glyco pMDI.
    • To evaluate the pharmacokinetic profile after single and repeated administration of Glyco pMDI.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Males and females patients aged 40-75 years;
    2. Written informed consent obtained before the first trial related activity.
    3. Diagnosis of moderate-severe COPD, according to the GOLD guidelines (2009);
    4. Able to understand the study procedures, the risks involved and ability to be trained to use the devices correctly.
    5. Body Mass Index (BMI) between 18.0 and 35 kg/m2;
    6. Current or ex-smokers with a smoking history of ≥ 10 pack years (e.g. ≥ 20 cigarettes per day for 10 years and 40 cigarettes per day for 5 years);
    7. Vital signs (systolic and diastolic blood pressure and heart rate) within the following ranges : 90 ≤ SBP ≤ 160; 50 ≤ DBP ≤90; 50 ≤ HR ≤ 100);
    8. Electrocardiogram (ECG) (12 lead) with computerized protocol interpretation considered as normal (120 ms ≤ PR ≤ 200 ms, QRS ≤ 120 ms, QTcF ≤ 450 ms). Minor deviations are acceptable provided that they are not judged clinically significant by the cardiologist;
    9. Post bronchodilator FEV1 between 40% and 80% predicted values (40% ≤ FEV1 ≤ 80%), documented at screening visit ;
    10. Post bronchodilator FEV1/Forced Vital Capacity (FEV1/FVC) ≤ 0.70 (absolute value) documented at screening visit;
    11. Airway reversibility of at least 100 mL within 30 to 45 minutes after inhalation of ipratropium 80 μg (for Part 2: historical reversibility is acceptable for patients who performed Part 1). If the reversibility criteria are not met and if the investigator deems it appropriate, the testing can be repeated once. This requirement must be met after re-testing during run-in period at least 24h prior to randomisation.
    E.4Principal exclusion criteria
    History of chronic or seasonal allergy
    2. Blood eosinophil count above 0.6 x 10^9/L.
    3. Clinically relevant findings on physical examination, laboratory or ECG parameters at screening.
    4. Occurrence of one of the following 24-h Holter ECG abnormalities at screening:
    a. More than 200 ventricular ectopics in 24 hours.
    b. Ventricular tachycardia;
    c. Second degree heart block.
    d. Sustained cardiac arrhythmias (atrial fibrillation, SVT, complete heart block).
    e. Any symptomatic arrhythmia (except isolated extra systoles)
    f. Sinus pauses ≥ 2.5 s
    5. Significant disease not related to COPD (eg. Myocardial infarction, stroke within the preceding 6 months)
    6. Respiratory tract infection (including upper tract) 4 weeks prior to Screening Visit requiring changing treatment
    7. Patients requiring oxygen therapy on a daily basis for chronic hypoxemia
    8. Patients who have been hospitalized in the previous 6 weeks prior to screening visit
    9. Having received an investigational product within the last 8 weeks before the Screening Visit.
    10. Inability to comply with study procedures or with study treatment intake, including inability to be trained with Vitalograph AIM.
    11. History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease which is considered to be clinically significant by the investigator.
    12. Intolerance/hypersensitivity or any contra-indication (e.g history of glaucoma) to treatment with M3 Antagonist or any of the excipients contained in the formulations used in the study.
    13. History of alcohol or substance abuse that in the opinion of the Investigator may be of clinical significance.
    14. Patients who have undergone major surgery in the 12 weeks before the Screening Visit.
    15. Patients treated with oral (slow-release included) or parental steroids 8 weeks prior to Screening Visit
    16. Patients treated with oral ß2-adrenergics, antihistamines, or theophyllines 1 month prior to Screening Visit or enzyme inducing or inhibiting drugs 2 months before the first administration.
    17. Patients treated with tiotropium in the 10 days prior to the Screening Visit.
    18. Female patients: pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until the termination of the gestation, confirmed by a positive serum human chorionic gonadotrophin laboratory test (> 5 mIU/mL. Serum pregnancy test to be done at Screening for verification). Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or are using an acceptable method of contraception.
    Male patients: must be sterile or they or their partner must be willing to use an approved method of contraception from the time of dose administration and until 30 days after the last dose of study. Patients must not donate sperm for 30 days after the last dose of study drug. A reliable method of contraception for male and female subjects (or their partner), depending on the method, can be one or more of the following ones:
    a) Surgical sterilization (i.e. bilateral tubal ligation, hysterectomy for females; vasectomy for males)
    b) Hormonal contraception (implantable, patch, oral)
    c) Double-barrier methods (any double combination of: IUD, male or female condom, diaphragm, sponge, cervical cap, condom, spermicide).
    Periodic abstinence (i.e. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study.
    E.5 End points
    E.5.1Primary end point(s)
    Part I
    Adverse Events (AEs) and Adverse Drug Reactions (ADRs), including occurrence of paradoxical bronchospasm;
    vital signs: heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP)
    12-lead ECG parameters: ventricular heart rate, PR, QRS, QT, QTcB, QTcF;
    abnormal findings on 12-lead ECG;
    24 h ECG Holter recordings;
    clinical chemistry and hematology, urinalysis.

    Part II
    Core periods: trough FEV1 at 12 h post-dose on Day 7 (before evening administration) defined as the mean of two measurements at 12 h and 12.5 h post-dose.
    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 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 Yes
    E.8.1.7.1Other trial design description
    PART I single-dose, PART II repeated dose
    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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA1
    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 Information not present in EudraCT
    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
    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 months
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    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 state64
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 64
    F.4.2.2In the whole clinical trial 64
    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 Decision2010-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-08-10
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