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    Summary
    EudraCT Number:2012-002198-72
    Sponsor's Protocol Code Number:
    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:2013-11-06
    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 number2012-002198-72
    A.3Full title of the trial
    Targeted retreatment of incompletely recovered COPD exacerbations with ciprofloxacin: a double-blind, randomised, placebo-controlled, multicentre Phase III trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Targeted retreatment with antibiotics following exacerbations of Chronic Obstructive Pulmonary Disease
    A.3.2Name or abbreviated title of the trial where available
    Targeted retreatment of COPD exacerbations
    A.4.1Sponsor's protocol code number
    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 SponsorImperial College London
    B.1.3.4CountryUnited Kingdom
    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 Institure for Health Research (NIHR)
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImperial College London
    B.5.2Functional name of contact pointNabila Youssouf
    B.5.3 Address:
    B.5.3.1Street AddressJoint Research Compliance Office, Imperial College London,510 5th floor Lab Block, Charing Cross,
    B.5.3.2Town/ cityFulham Palace Road| London
    B.5.3.3Post codeW6 8RF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0203 311 0213
    B.5.5Fax number0203 311 0203
    B.5.6E-mailNabila.Youssouf@imperial.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 Yes
    D.2.1.1.1Trade name Ciprofloxacin
    D.2.1.1.2Name of the Marketing Authorisation holderRanbaxy (UK) 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 nameCiprofloxacin
    D.3.4Pharmaceutical form Capsule
    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 INNCiprofloxacin
    D.3.9.1CAS number 85721-33-1
    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 number500
    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 placeboCapsule
    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) - exacerbations
    E.1.1.1Medical condition in easily understood language
    Chronic obstructive pulmonary disease (COPD) - a chronic lung condition usually caused by smoking, with ongoing chronic symptoms punctuated by episodes of worsening ('exacerbations')
    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 16.1
    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 16.1
    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 principal research question is whether an extra course of antibiotics, given two weeks after an exacerbation (flare up) of chronic obstructive pulmonary disease, can prevent repeat exacerbations in those patients who have not fully recovered from the first exacerbation.
    E.2.2Secondary objectives of the trial
    Secondary objectives for this study will include:

    1) Whether patients’ recovery from the first exacerbation is faster with the antibiotic treatment than with placebo
    2) The effects of the antibiotic treatment, compared to placebo, on:
    - The number of side effects and adverse (untoward) events experienced by patients
    - The frequency (rate) of exacerbations during the 3-month study follow-up period
    - The total number of further antibiotic courses received during 90 day follow-up in patients
    - Whether patients are readmitted to hospital during the study period
    - Respiratory healthcare status, assessed using symptom questionnaires (St George's Respiratory Questionnaire [SGRQ] and COPD Assessment Test [CAT])
    - Change in patients' lung function from study entry to 90 days
    - Change in inflammation (measured by blood tests for CRP, a blood marker of inflammation) from study entry to 90 days
    - Changes in bacterial resistance to ciprofloxacin
    - Change in the number of bacteria i
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Pre-existing diagnosis of COPD, which will be confirmed by post-bronchodilator FEV1/FVC ratio of <0.7 at screening
    - Severity of disease: Patients with a measured FEV1<80% of predicted normal values
    - COPD exacerbation 14 days prior to study enrolment, treated with 5-14 days of non-quinolone antibiotics
    - Age: ≥ 45 years of age at screening.
    - Measured CRP (C-reactive protein) ≥8mg/L AND/OR persistence of one or more major symptom at the screening visit. The individual ‘major symptoms’ are dyspnoea, increased sputum purulence and increased sputum volume. Symptoms will be assessed and documented using a standardised short questionnaire completed by the patient.
    - Able to complete questionnaires for health status and symptoms and to keep written diary cards
    - Informed Consent: Patients must be able to give their signed and dated written informed consent to participate
    E.4Principal exclusion criteria
    Patients meeting any of the following criteria will not be enrolled in this study:

    - Patients with other clinically predominant chronic respiratory disease. Patients with other respiratory diagnoses may be enrolled if COPD is the predominant condition (in the judgment of the study doctor) and if the additional diagnosis will not affect the safety of the patient or validity of their results.
    - Intubated patients receiving invasive positive-pressure ventilation. Patients receiving non-invasive ventilation and/or oxygen therapy may be included if they otherwise fulfil the inclusion and exclusion criteria.
    - Patients with known hypersensitivity to ciprofloxacin or any of the excipients used in its manufacture or that of the matched placebo.
    - Patients on long term antibiotics for other conditions
    - Patients already retreated with antibiotics for the current exacerbation (i.e. between day -14 and the screening visit)
    - Patients who at the screening visit are too unwell for randomisation and/or fulfil one or more of the following criteria:
    1) SaO2 <88% on air (OR less than their usual known baseline saturation level on their usual oxygen dose if using long-term oxygen therapy)
    2) Systolic blood pressure <90mmHg OR >200mmHg
    3) Resting tachypnoea >28 breaths/minute
    4) Resting tachycardia >120 beats/minute
    5) Drowsy or confused
    6) Clinical examination suggesting pneumonia or complications (e.g. parapneumonic effusion/empyema)
    7) Further antibiotic treatment required in the judgment of the study doctor and therefore would be at risk if randomised to the placebo arm
    - Female patients who are pregnant or planning on becoming pregnant during the study, or are breastfeeding.
    - Clinically relevant previously measured abnormal laboratory values at the screening assessment that could interfere with the objectives of the trial or safety of the volunteer.
    - Patient taking clinically significant contraindicated medication, as per the SmPCs
    - Patients who are actively enrolled in another interventional clinical trial (i.e. taking another IMP). Patients enrolled in observational COPD research (e.g. the London COPD Cohort Study [a recruitment source for this study] or COPDMAP) may continue as long as a) this study does not adversely impact on the scientific validity of the other study, and b) simultaneous participation is not unduly onerous for the patient. See section 8.8.
    - Elderly patients (≥80 years) on long-term (>6 weeks) systemic corticosteroids at a dose of ≥5mg/day prednisolone or equivalent [these patients have an increased risk of tendon rupture with ciprofloxacin].
    - Patients with any other condition precluding enrolment in the trial, according to the assessment of the study doctor. This will be documented at screening.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome will be to assess the effect of retreatment with ciprofloxacin, compared to placebo, on the time to onset of the next exacerbation (from the start of retreatment with the IMP and up to a maximum follow-up period of 90 days). Exacerbation will here be defined using either HCU or diary card definitions.

    The onset of the next (recurrent) exacerbation will be defined as either:
    1) The first day of treatment with antibiotics and/or steroids for an exacerbation of COPD (HCU definition), or
    2) The first of two or more consecutive days of increased respiratory symptoms recorded on the daily diary cards, either:
    a. Two ‘major’ symptoms (increased dyspnoea, increased sputum volume, or increased sputum purulence), or
    b. One ‘major’ and one ‘minor’ symptom (cold, wheeze/chest tightness, sore throat, cough or fever).
    A recurrent exacerbation will only be diagnosed based on diary cards if there are a minimum of five symptom-free days after the end of the previous exacerbation.
    The end of the first exacerbation will be defined as the first day of two consecutive symptom-free days.
    E.5.1.1Timepoint(s) of evaluation of this end point
    90 days after study enrolment.
    E.5.2Secondary end point(s)
    •Duration of (first) exacerbation recovery (from point of retreatment V1) based on diary card symptoms
    •Treatment-related adverse events
    •Exacerbation frequency (rate) during follow-up.
    •Total number of antibiotic courses received during 90 day follow-up
    •(Re)admission/re-attendance to hospital during 90 day follow-up
    •Changes in respiratory healthcare status, assessed using SGRQ and CATChange in lung function from study entry to 90 days
    •Change in CRP from study entry to 90 days
    •Changes in bacterial resistance to ciprofloxacin as assessed by standard culture and sensitivity methods at trial beginning and end (in those patients in whom sputum is spontaneously expectorated)
    •Change in bacterial load from trial beginning to end (in those patients in whom sputum is spontaneously expectorated)
    E.5.2.1Timepoint(s) of evaluation of this end point
    90 days after study entry
    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) 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 No
    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 trial2
    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 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 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 months10
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days28
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 130
    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 state231
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 231
    F.4.2.2In the whole clinical trial 231
    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)
    There are no arrangements for continued provision of this intervention in this way (i.e. targeted elective re-treatment) after the trial end. The investigational medication, ciprofloxacin, is routinely available and therefore may be prescribed by patients' usual doctors as indicated in the future.

    After the trial end patients will return to the care of their general practitioner and/or usual respiratory care arrangements.....
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Primary Care Research Network, London South Bank University
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-02-22
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