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Promixin in patients with non-cystic fibrosis bronchiectasis

  • Research type

    Research Study

  • Full title

    A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)

  • IRAS ID

    213606

  • Contact name

    Charles Haworth

  • Contact email

    charles.haworth@papworth.nhs.uk

  • Sponsor organisation

    Zambon SpA

  • Eudract number

    2015-002743-33

  • Duration of Study in the UK

    1 years, 8 months, 29 days

  • Research summary

    This study will investigate if the use of inhaled Promixin® (colistmethate sodium), taken twice daily for 12 months, delays the time to the first pulmonary exacerbation compared to placebo in subjects with non–cystic fibrosis (CF) bronchiectasis chronically infected with the bacterium Pseudomonas aeruginosa. It will also establish if this has the potential to decrease the number of pulmonary exacerbations experienced in a given time period. Bronchiectasis is a lung condition characterised by chronic inflammation, wall thickening and widening of the airways. The ability to clear mucus is impaired, leaving lungs susceptible to infection which leads to airway inflammation, obstruction of the small airways and destruction of the bronchial wall. Non-CF bronchiectasis is currently treated with antibiotics, however, long-term inhaled anti-pseudomonal antibiotics (such as colistmethate sodium) have already been used to some extent to reduce the number of pulmonary exacerbations. None of these antibiotics are approved for inhalation for the treatment of pseudomonal infection in non-CF bronchiectasis. 2 clinical studies with Promixin® have been completed and reported, the second investigated if inhaled Promixin® increased the time to the next pulmonary exacerbation and improved the symptoms experienced by reducing the bacterial load in the lungs in subjects with non-CF bronchiectasis infected with susceptible P. aeruginosa. This study plans to further investigate the possibility of inhaled Promixin® increasing time between exacerbations and reduce their number. The study will last approximately 25 months, the treatment duration will be 12 months and will include about 264 subjects. The safety profile of inhaled Promixin® will also be evaluated over this period. There are 7 visits and a follow up phone call during which subjects will provide sputum samples, undergo a physical examination and spirometry tests. At two visits they will have an ECG and a blood test. A questionnaire will be completed at some visits.

  • REC name

    East of England - Cambridge East Research Ethics Committee

  • REC reference

    17/EE/0017

  • Date of REC Opinion

    21 Feb 2017

  • REC opinion

    Further Information Favourable Opinion