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    Summary
    EudraCT Number:2010-022110-29
    Sponsor's Protocol Code Number:SG006
    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:2010-08-27
    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 number2010-022110-29
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled Phase II study, comparing the efficacy and safety of inhaled SNG001 to placebo administered to COPD patients after the onset of a respiratory viral infection for the prevention or attenuation of COPD symptoms caused by respiratory viruses
    A.3.2Name or abbreviated title of the trial where available
    Phase II: Inhaled SNG001 in COPD subjects
    A.4.1Sponsor's protocol code numberSG006
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 SponsorSynairgen Research Limited
    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 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 nameinterferon beta-1a (IFN-β1a)
    D.3.2Product code SGN001
    D.3.4Pharmaceutical form Nebuliser 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 INNinterferon beta-1a
    D.3.10 Strength
    D.3.10.1Concentration unit million IU million international units
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6MIU per 0.53 ml
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 placeboNebuliser 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
    Prevention or attenuation of COPD symptoms caused by respiratory viruses
    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
    This is a Phase II study in which we are trying to see if SNG001 is better than placebo at controlling COPD symptoms during common cold infections. SNG001 is given by a nebulizer, and the solution contains interferon-β, which is an antiviral protein (which we all have). We believe there is a deficiency of this protein in COPD patients when respiratory viruses are present. This may explain why COPD patients suffer an exacerbation (deterioration) of their symptoms when they get a cold (or flu).
    We will test the drug by looking to see if their COPD symptom (EXACT-Pro) peak score is lower in the SNG001 treated subjects compared to the placebo treated group between day 3 and day 14. The COPD score is a score calculated daily and consists of questions regarding the subjects COPD symptoms.

    We will have 83 subjects in each group. This has been calculated to be enough subjects to make a meaningful statistical comparison.
    E.2.2Secondary objectives of the trial
    This is the first time that a drug like SNG001 has been used to treat COPD subjects during common cold infections. As such the research team (led by experienced statisticians) will analyse data from a variety of other measurements made during the study. These will be:

    a) The same as the primary objective but looking at the per protocol population rather than the modified intention to treat population.
    b) To look at the EXACT-PRO scores in a number of different ways; specifically the peak score between days 3 and 28; to see if the area under the curve is lower in the SNG001 treated subjects compared to the placebo treated group between day 3 and day 7 and day 3 and day 28; and to look at the peak rolling day average between days 3 and 7 and days 3 and 28.
    c) To look at the effect of inhaled SNG001 to placebo on FEV1 between day 1 and 28.
    d) To compare the effect of inhaled SNG001 to placebo on the reduction of viral load on days 4 and 7 in sputum.
    e) To compare the effec
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1)Male or female, over 40 years of age.
    2)A confirmed diagnosis of COPD or a medical history consistent with a diagnosis of COPD.
    3)FEV1 > 20% of predicted and < 70% of predicted post-bronchodilator, on the day of screening.
    4)To have had at least one COPD exacerbation suspected to have been caused by a respiratory virus in the last 24 months requiring intervention with oral steroids or antibiotics.
    5)Has experienced respiratory virus symptoms that have developed within the previous 48 hours, but preferably 24 hours, specifically a blocked or runny nose, and a sore or scratchy throat.
    6)Provide written informed consent.
    7)Females of child-bearing potential must be using a medically acceptable and adequate form of birth control and agree to maintain this usage throughout the duration of the study.
    8)Motivation (in the Investigator’s opinion) to complete all study visits and assessments, the ability to communicate well with the Investigator and be capable of understanding the nature of the research and its treatment, including its risks and benefits.
    E.4Principal exclusion criteria
    1)Any condition, including findings in the medical history that, in the opinion of the Investigator, constitutes a risk or a contraindication for the participation of the subject in the study or that could interfere with the study objectives, conduct or evaluation.
    2)Patients who have a current moderate or severe exacerbation of COPD.
    3)Oxygen saturation of less than 92% (taken on air, unless the subject is routinely prescribed oxygen when they are stable).
    4)Current participation in an interventional trial.
    5)Patients who have received a dose of a test product (IMP) within 12 weeks prior to entry into the study for small molecules and within 6 months prior to entry into the study for biologicals.
    6)Patients who have had a COPD exacerbation and/or upper or lower respiratory tract infection that resolved less than 4 weeks ago.
    7)Patients who are currently taking, or have taken oral steroids or antibiotics within the last four weeks.
    8)Active interstitial lung disease or past history of lung cancer not considered cured, significant bronchiectasis, cystic fibrosis or a history of significant chronic asthma.
    9)Patients with serious underlying medical conditions that could impact interpretation of results should be excluded (e.g. infection, haematological disease, malignancy, renal, hepatic, coronary heart disease or other cardiovascular disease, including arrhythmias, endocrinological or gastrointestinal disease).
    10)History of hypersensitivity to natural or recombinant IFN-β or to any of the drug preparation excipients.
    11)Patients with current severe depression and/or suicidal ideation.
    12)History of epilepsy or seizures after the age of 5 years.
    13)Recent history of drug or alcohol abuse.
    14)Female who is breast-feeding, pregnant or intends to become pregnant.
    15)Patients who require more than 12 hours’ oxygen therapy per day.
    16)Patients who are currently in a pulmonary rehabilitation programme.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the peak EXACT-PRO score observed between days 3 and 14 in the mITT population. Days are defined with respect to day 1 being Visit 1 which occurs within 48 hours of the onset of cold symptoms and is the day of first dose.

    The primary objective will be assessed by testing the following null hypothesis:

    H0: There is no difference in the peak EXACT-PRO score observed between days 3 and 14 for inhaled SNG001 compared to placebo in the mITT population

    versus the two-sided alternative hypothesis:

    H1: There is a difference in the peak EXACT-PRO score observed between days 3 and 14 for inhaled SNG001 compared to placebo in the mITT population.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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
    compare frequency of use of concomitant medications
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    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 concerned10
    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 Information not present in EudraCT
    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
    last subject last visit
    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 months12
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months12
    E.8.9.2In all countries concerned by the trial days0
    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 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 state166
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 166
    F.4.2.2In the whole clinical trial 166
    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)
    None at this stage in the drugs development.
    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 Decision2010-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-08
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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