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Inhaled SNG001 in COPD patients

  • Research type

    Research Study

  • Full title

    A randomised, double-blind, placebo-controlled study, in COPD patients with and without a confirmed respiratory virus infection assessing anti-viral biomarker responses and clinical effects of inhaled SNG001 compared to placebo.

  • IRAS ID

    232887

  • Contact name

    Tom Wilkinson

  • Contact email

    t.wilkinson@soton.ac.uk

  • Sponsor organisation

    Synairgen Research Limited

  • Eudract number

    2017-003679-75

  • Duration of Study in the UK

    1 years, 5 months, 0 days

  • Research summary

    When people with COPD get a respiratory virus such as a cold or flu it often increases COPD symptoms. SNG001 is the study medication, and it contains interferon beta which is a natural antiviral protein. We will test SNG001 to find out if it can boost anti-viral responses and minimise the worsening of COPD symptoms/lung function. Interferon-β is taken by injection by thousands of multiple sclerosis patients. In this study, SNG001 will be inhaled via a nebuliser. Lung cells of COPD patients do not fight the virus very well when they are infected by the common cold virus. When interferon-β is administered to the cells, it is thought that the anti-viral response is restored.
    For the main part of the study, interested COPD Patients who consent to take part in the trial will be asked to contact the research team when they experience cold or flu symptoms or a deterioration of their COPD symptoms. At this point, eligible patients will undergo a virus detection test and those that test positive for a virus will be randomised 1:1 to receive 6 MIU SNG001 or placebo once daily for 14 days. Doses will be delivered in the clinic and at home, by a breath-actuated nebuliser. It is important that the first dose of study medication will be administered within 24 hours of the initial onset of upper respiratory virus symptoms or deterioration of COPD symptoms. Subjects will be assessed for changes in anti-viral biomarkers, lung function and COPD symptoms. Efficacy and safety will be monitored until at least 14 days post end of treatment.
    Prior to the main part of the trial, 8 COPD patients will take three consecutive daily doses of SNG001 to make sure it is safe in COPD, it has been safely given to about 150 asthma patients up until now.

  • REC name

    South Central - Hampshire A Research Ethics Committee

  • REC reference

    17/SC/0532

  • Date of REC Opinion

    1 Dec 2017

  • REC opinion

    Further Information Favourable Opinion