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    Summary
    EudraCT Number:2004-002769-18
    Sponsor's Protocol Code Number:MKC101614
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-02-21
    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 ConcernedFinland - Fimea
    A.2EudraCT number2004-002769-18
    A.3Full title of the trial
    A 28-day, randomised, double-blind, placebo-controlled study to assess the safety, tolerability, anti-inflammatory effect and steadystate pharmacokinetics of SB-681323 7.5 mg per day in patients with chronic obstructive pulmonary disease.
    A.4.1Sponsor's protocol code numberMKC101614
    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 SponsorGlaxoSmithKline R&D
    B.1.3.4CountryUnited Kingdom
    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 Information not present in EudraCT
    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 nameSB681323 Tablets
    D.3.2Product code SB681323
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeSB681323
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 nameSB681323 Tablets
    D.3.2Product code SB681323
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeSB681323
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.0
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 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
    Chronic Obstructive Pulmonary Disease (COPD)
    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
    • To assess the safety and tolerability of SB-681323 administered orally for 28 days in subjects with COPD.
    • To assess the systemic anti-inflammatory activity of SB-681323 administered orally for 28 days in subjects with COPD as determined by serum concentrations of CRP.
    E.2.2Secondary objectives of the trial
    • To assess the pulmonary anti-inflammatory activity of SB-681323 administered orally for 28 days in subjects with COPD.
    • To assess the systemic anti-inflammatory activity of SB-681323 administered orally
    for 28 days in subjects with COPD as determined by other markers.
    • To assess the effect on pulmonary function of SB-681323 administered orally for 28 days in subjects with COPD.
    • To assess the effect on dyspnoea of SB-681323 administered orally for 28 days in subjects with COPD.
    • To assess the pharmacokinetics of SB-681323 in subjects with COPD.
    • To explore the potential correlation between plasma concentrations of SB-681323
    and serum concentrations of CRP.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Male adults or female adults of non-childbearing potential who are between 40 and
    75 years of age (inclusive).
    Note: A female is eligible to enter and participate in the study if she is of nonchildbearing
    potential (i.e. physiologically incapable of becoming pregnant),
    including any female who is post-menopausal. For the purposes of this study, post
    menopausal is defined as one year without menses.
    2. Subjects with a clinical diagnosis of COPD in accordance with the European
    Respiratory Society Consensus Statement and subjects categorised with moderate
    COPD as defined by the GOLD guidelines of 2003 [GOLD, 2003].
    3. Subjects with a cigarette smoking history of ≥ 10 pack years (1 pack year = 20
    cigarettes smoked per day for 1 year or the equivalent). Both current and former
    smokers are eligible to be enrolled. A former smoker is defined as a subject who has
    not smoked for ≥6 months at Visit 1.
    4. Subjects with a post-bronchodilator FEV1 to FVC ratio (FEV1:FVC) < 0.7 at Visit 1.
    Subjects will be assessed 30 (± 5) minutes after receiving salbutamol 400 µg.
    5. Subjects with a post-bronchodilator FEV1 ≥ 50% and < 80% of predicted normal for
    height, age and sex at Visit 1. Subjects will be assessed 30 (± 5) minutes after
    receiving salbutamol 400 µg.
    6. Subjects who have been receiving inhaled corticosteroids for a minimum of 6 weeks
    prior to Screening.
    7. Subjects capable of providing signed written informed consent to participate.
    A subject will be eligible for randomisation at the end of the run-in period only if the
    following additional criteria apply:
    1. Subjects with a serum CRP concentration of >3mg/L at Visit 1a.
    2. Subjects with no evidence of an ongoing acute infection or sinus symptoms.
    E.4Principal exclusion criteria
    1. Women who are pre-menopausal and of child-bearing potential.
    2. Subjects with a current diagnosis of asthma.
    3. Subjects who have required hospitalisation or treatment with oral corticosteroids and/or antibiotic therapy for acute worsening of COPD or lower respiratory tract infection in the 6 weeks prior to Screening.
    4. Subjects with active tuberculosis, sarcoidosis or clinically overt bronchiectasis.
    5. Subjects with rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with chronic inflammation (e.g. Inflammatory Bowel Disease).
    6. Subjects with chronic infections such as gingivitis, periodontitis, prostatitis, gastritis, and urinary tract infections.
    7. Subjects with clinically significant renal disease, diabetes mellitus/metabolic syndrome, hypertension or any other clinically significant cardiovascular,
    neurological, endocrine, or haematological abnormalities that are uncontrolled on
    permitted therapy.
    8. Subjects with clinically significant gastrointestinal or hepatic abnormalities.
    9. Subjects with hypoxaemia. (All subjects must have an O2 saturation of ≥88% on
    room air.)
    10. History of Gilbert's syndrome or elevated bilirubin concentrations. Subjects with a
    total bilirubin concentration above the upper limit of normal at Screening will be
    excluded
    11. History of increased liver function tests (ALT, AST) above upper limit of normal in
    the past 6 months and/or liver function tests (bilirubin, ALT, AST) above upper limit
    of normal at Screening (Visit 1).
    12. Subjects who have undergone recent surgery including lung volume reduction
    surgery or have conditions that prevent them from performing spirometry.
    13. Subjects who require treatment with any of the following from the Screening (Visit 1) until study completion:
    Inhaled corticosteroids
    Inhaled cromolyn sodium or nedocromil
    Xanthines (theophylline preparations).
    Leukotriene modifiers
    Tiotropium
    Long-acting inhaled beta2-agonists (salmeterol, formoterol)
    Oral beta2-agonists
    14. Subjects who have received treatment with oral, intravenous or intra-articular
    corticosteroids within 6 weeks of Screening or thereafter
    15. Subjects with any known hypersensitivity to salbutamol or ipratropium bromide.
    A subject will not be eligible for randomisation at the end of the run-in period if the
    following additional criterion applies:
    1. Subjects who have experienced an exacerbation during the run-in period requiring
    treatment with oral corticosteroids and/or antibiotics and/or hospitalisation.
    E.5 End points
    E.5.1Primary end point(s)
    There are two primary endpoints for this study. These are:
    • The safety and tolerability of SB-681323 administered orally for 28 days as assessed by the incidence of alanine aminotransferase (ALT) concentrations >3 x ULN
    • The mean ratio to baseline after 28 days treatment of the serum concentration of
    CRP.
    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 Information not present in EudraCT
    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 Yes
    E.8.1.6Cross over No
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Information not present in EudraCT
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    LSLV
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    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) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 82
    F.4.2.2In the whole clinical trial 82
    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 Decision2005-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-04-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-03-02
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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