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    Summary
    EudraCT Number:2011-002082-38
    Sponsor's Protocol Code Number:RG_11-123
    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:2012-01-06
    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 number2011-002082-38
    A.3Full title of the trial
    A study of the effects of Simvastatin on neutrophil function in elderly subjects
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of Simvastatin on the immune system of healthy older people
    A.3.2Name or abbreviated title of the trial where available
    Improving Neutrophil responses in the healthy elderly
    A.4.1Sponsor's protocol code numberRG_11-123
    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 Birmingham
    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 supportQueen Elizabeth Hospital Charities
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQueen Elizabeth Hospital Birmingham NHS Trust
    B.5.2Functional name of contact pointClinical Trials Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressLung Investigation Unit, QEHB
    B.5.3.2Town/ cityBirmingham
    B.5.3.3Post codeB15 2TH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01214721311
    B.5.5Fax number01213713887
    B.5.6E-mailanita.pye@uhb.nhs.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 Simastatin 80mg once daily
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp and Dohme 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 nameSimvastatin
    D.3.2Product code PL0025/0366
    D.3.4Pharmaceutical form 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 INNSimvastatin
    D.3.9.1CAS number 79902-63
    D.3.9.3Other descriptive nameSimvastatin
    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 number80
    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 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
    We are investigating the effects of Simvastatin 80mg on neutrophil function (using in vitro studies of neutrophil function), in healthy elderly subjects as there is evidence to suggest that Simvastatin may improve neutrophil responses to inflammation in this population. Clinical and experimental data have suggested that response to infection is improved in patients receiving statins. Our own preliminary in vitro data suggest that this may be due to enhance neutrophil migration.
    E.1.1.1Medical condition in easily understood language
    Healthy older subjects. The usual indication for Simvastatin is to treat raised cholesterol levels in people at risk of heart disease
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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
    Hypothesis. The age-related loss of neutrophil function contributes to delayed resolution of infection and inflammation. These changes in neutrophil function with advanced age are a result of alterations in signal transduction pathways due to altered membrane cholesterol levels and can be corrected using simvastatin. In vitro studies have confirmed that neutrophils isolated from elderly subjects respond differently to those from young donors in terms of migration, phagocytosis and superoxide production when pre-treated with physiological concentrations of Simvastatin. Question: Is this clinically relevant in vivo? Does a course of treatment with simvastatin improve migratory dynamics, phagocytosis and superoxide generation of neutrophils isolated from the peripheral blood of older subjects and is this associated with altered membrane cholesterol levels?
    E.2.2Secondary objectives of the trial
    There are no secondary questions.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria 1. Age > 60 years 2. Competent to provide informed consent and participate 3. MRC Dyspnoea scale < 2 4. Normal lung function (FEV1 > 80% predicted, FVC > 80% predicted) 5. Normal peripheral oxygenation (as assessed by pulse oximetry, with oxygen saturations above 92%) 6. Free from medications known to alter immune cell function (as outlined in protocol) 7. No clinical evidence of acute infection or chronic illness. 8. Normal liver and kidney function as assessed by peripheral blood liver function tests, urea and creatinine and urinary dipstick.
    E.4Principal exclusion criteria
    Exclusion criteria 1. Unable to provide informed written consent 2. History of significant chronic illness including Diabetes, COPD, Asthma, TB, Bronchiectasis, Malignancy, Auto immune disease, Cardiovascular disease. 3. Clinical evidence of acute viral or bacterial infection 4. Any regular medical therapies that may alter immune function 5. Declines to provide permission for GP to be informed 6. Any contraindications for statin therapy (hypersensitivity or abnormal renal or liver function tests)
    E.5 End points
    E.5.1Primary end point(s)
    1. Assessment of adhesion, chemokinesis and chemotaxis by neutrophils Neutrophil adhesion and migration will be assessed in a microscopy slide based system using established methodology (35). Chemoattractants used will be those that act via CXC receptors (CXCL8 and GROα), those that act through other receptors (e.g., fMLP). 2. Cell surface receptors. Isolated neutrophils from both media will also be used to measure surface expression of receptors known to be important in chemotaxis, including CXCR1, CXCR2, CD11, CD18, CD44, CD47 and CD55, using FACS analysis, to assess differences in migratory receptor and opsonisation receptor expression. 3. Assessment of bacterial killing The phagocytic function and superoxide production of neutrophils will be examined using standard assays. Respiratory burst in response to fMLP will be determined in isolated neutrophils by measuring the generation of superoxide in a lucigenin-based assay. Phagocytosis of E Coli by neutrophils will be measured using a commercially available kit (Phagotest, Orpegen, Germany).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cell studies will be performed after completion of the first arm of the crossover study and following completion of the study.
    E.5.2Secondary end point(s)
    Nil
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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) No
    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 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
    The end of the trial will be the last visit of the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days24
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days25
    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) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 33
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state33
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 0
    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)
    This clinical trial is studying cellular mechanisms rather than disease outcomes, so it is unlikely that any positive disease benefit will be felt by the participant for the duration of the study. If the clinical trial demonstrated that neutrophil function can be positively altered on Simvastatin, so that neutrophils were more accurate during migration and more effective at killing and clearing bacteria, we would then need to conduct a larger, longer clinical trial
    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 Decision2012-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-09-01
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