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    Summary
    EudraCT Number:2017-002779-24
    Sponsor's Protocol Code Number:3.089.17
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-07-05
    Trial 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 number2017-002779-24
    A.3Full title of the trial
    A randomised, double-blind placebo controlled trial of the effectiveness of the beta-blocker bisoprolol in preventing exacerbations of chronic obstructive pulmonary disease.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Bisoprolol in COPD Study (BICS)
    A.3.2Name or abbreviated title of the trial where available
    Bisoprolol in COPD study (BICS)
    A.4.1Sponsor's protocol code number3.089.17
    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 SponsorUniversity of Aberdeen
    B.1.3.4Country
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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
    B.Sponsor: 2
    B.1.1Name of SponsorNHS Grampian
    B.1.3.4Country
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNational Institute for Health Research
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Aberdeen
    B.5.2Functional name of contact pointDr Seonaidh Cotton
    B.5.3 Address:
    B.5.3.1Street AddressDivision of Applied Health Sciences
    B.5.3.2Town/ cityMedical School, Foresterhill,
    B.5.3.3Post codeAB252ZD
    B.5.4Telephone number01224438178
    B.5.6E-mails.c.cotton@abdn.ac.uk
    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.2.1.1.1Trade name Bisoprolol
    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 nameBisoprolol
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBisoprolol fumarate
    D.3.9.1CAS number 104344-23-2
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.25
    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 placeboFilm-coated tablet
    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)
    E.1.1.1Medical condition in easily understood language
    Chronic Obstructive Pulmonary Disease (COPD)
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.2System Organ Class 100000004855
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10010953
    E.1.2Term COPD exacerbation
    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
    The primary objective is to determine whether adding bisoprolol (maximum dose 5mg a day) to existing COPD treatment in patients who have chronic obstructive pulmonary disease will reduce the number of exacerbations (or flare ups) of the condition. If the treatment is effective, we will also assess whether it is cost effective
    E.2.2Secondary objectives of the trial
    The secondary objectives are to compare the following outcomes between participants treated with bisoprolol, and those treated with placebo:
    -Hospital admissions with a primary diagnosis of COPD exacerbation.
    -Total number of emergency hospital admissions.
    -Total number of major adverse cardiovascular events (MACE).
    -Lung function.
    -Changes in breathlessness during treatment.
    -All-cause, respiratory and cardiac mortality.
    -Drug reactions and serious adverse events.
    -Health related quality of life.
    -Disease specific health status.
    -Health care utilisation.
    -Incremental cost-per-exacerbation avoided.
    -Costs to the NHS and patients and lifetime cost-effectiveness based on extrapolation modelling.
    -Modelled lifetime incremental cost per Quality Adjusted Life Year.
    -Treatment effects in participants with and without clinically diagnosed heart disease.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Aged ≥ 40 years.
    -A smoking history of at least 10 pack years.
    -An established predominant diagnosis of COPD (NICE Guideline definition: post bronchodilator FEV1<80% predicted, FEV1/FVC<0.7) receiving treatment as per local guidelines’.
    -A history of at least two exacerbations requiring treatment with antibiotics and/or oral corticosteroid use in the previous year, based on patient report.
    -Clinically stable with no COPD exacerbation for at least 4 weeks.
    -Able to swallow study medication.
    -Able and willing to give informed consent to participate.
    -Able and willing to participate in the study procedures, complete study questionnaire.
    -Able and willing to undergo spirometric assessment, able to perform an FEV1 manoeuvre as a minimum.
    E.4Principal exclusion criteria
    -A current sole respiratory diagnosis of asthma.
    -Any diagnosis of asthma before the age of 40 years.
    -A predominant respiratory disease other than COPD.
    -Any significant disease/disorder which, in the investigator’s opinion, either puts the patient at risk because of study participation or may influence the results of the study or the patient's ability to participate in the study.
    -Previous allocation of a randomisation code in the study or current participation in another interventional study (CTIMP or non-CTIMP).
    -Already taking beta-blocker.
    -Known or suspected hypersensitivity to beta-blocker.
    -For women, current pregnancy or breast-feeding, or planned pregnancy during the study.
    -Unable to perform spirometry (FEV1 manoeuvre).
    -Current resting (5 minutes sitting) heart rate <60 bpm.
    -Current resting (5 minutes sitting) systolic blood pressure <100mmHg.
    -2nd, 3rd degree heart block on ECG (unless pacemaker in situ).
    -Conditions for which beta-blocker use is a guideline recommendation, i.e. heart failure, or within the last year: myocardial infarction, acute coronary syndrome.
    -Current tachyarrythmia or bradyarrhythmia (including sick sinus syndrome, sinoatrial block) requiring treatment.
    -Current treatment with interacting drugs:
    o heart rate limiting drug such as calcium channel blockers (diltiazem, verapamil), ivabradine,
    o class-I antiarrhythmic drugs (e.g. quinidine, disopyramide; lidocaine, phenytoin; flecainide, propafenone),
    o centrally-acting antihypertensive drugs (e.g. clonidine methyldopa, moxonidine, rilmenidine).
    -Severe peripheral arterial occlusive disease, severe forms of Raynauds syndrome.
    -Conditions that are known to be triggered by beta-blockers or beta-blocker withdrawal including myasthenia gravis, periodic hypokalaemic paralysis, pheochromocytoma, thyrotoxicosis and psoriasis/history of psoriasis.
    E.5 End points
    E.5.1Primary end point(s)
    The primary clinical outcome measure will be the total number of exacerbations of COPD necessitating changes in management (minimum management change use of oral corticosteroids and/or antibiotics) during the one year treatment period, as reported by the participant.

    The primary economic outcome measure will be cost per QALY gained during the one year treatment period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The number of participant reported exacerbations of COPD requiring treatment with antibiotics and/or oral corticosteroids will be ascertained at the 26 and 52 week assessment visits.
    E.5.2Secondary end point(s)
    -Total number of COPD exacerbations requiring hospital admission*.
    -Time to first exacerbation of COPD.
    -Total number of emergency hospital admissions (all causes)*.
    -Total number of major adverse cardiovascular events (MACE) (defined by cardiovascular death, hospitalisation for myocardial infarction, heart failure, or stroke), percutaneous coronary intervention or coronary artery bypass grafting.
    -Lung function (FEV1, FVC) post bronchodilator using spirometry performed to ATS/ERS standards.
    -Breathlessness using Baseline and Transition Dyspnoea Indices (BDI & TDI).
    -All-cause, respiratory and cardiac mortality.
    -Serious adverse events, adverse reactions.
    -Health related quality of life using EuroQoL 5D (EQ-5D-5L) Index.
    -Disease specific health status using the COPD Assessment Test (CAT).
    -Utilisation of primary or secondary health care for respiratory events.
    -Change in disease associated symptoms using the Hull Airways Reflux Questionnaire (HARQ) [this will only be done at some recruitment sites].
    -Modelled lifetime incremental cost per Quality Adjusted Life Year.
    E.5.2.1Timepoint(s) of evaluation of this end point
    These will be assessed at the 26 and 52 week assessment visits.
    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 No
    E.6.5Efficacy No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned160
    E.8.5The trial involves multiple Member States No
    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 Yes
    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
    The end of clinical follow up for each participant is defined as completion of the weaning off the study medication 3 weeks after follow up visit at 12 months. The end of clinical follow up is when the last participant weans off study medication 3 weeks after the follow up visit at 12 months.

    The end of the trial is defined as the end of funding.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 800
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 770
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state1574
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1574
    F.4.2.2In the whole clinical trial 1574
    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)
    We do not plan to unblind individual participants at the end of their clinical follow-up. Thus, participants will not be told whether they were taking bisoprolol. Participants will be reminded that bisoprolol is not licensed for the treatment of COPD and we would not advise its use until its therapeutic role is established.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-06-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-22
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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