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ICE-T

  • Research type

    Research Study

  • Full title

    Iron and Chronic Obstructive Pulmonary Disease (COPD) Exercise Trial

  • IRAS ID

    204579

  • Contact name

    Michael Polkey

  • Contact email

    M.Polkey@rbht.nhs.uk

  • Sponsor organisation

    Royal Brompton and Harefiled NHS Foundation Trust, Royal Brompton Hospital

  • Eudract number

    2016-000829-39

  • Duration of Study in the UK

    1 years, 10 months, 31 days

  • Research summary

    Background: Despite optimal medical treatment individuals with Chronic obstructive pulmonary disease remain significantly disabled. A further contributing factor to disability may be iron deficiency, a common nutritional deficiency. Iron plays a critical role within cells and with the transport and storage of oxygen. Exercise capacity relates to the oxygen-carrying capacity of haemoglobin and exercise endurance correlates more closely to iron storage.

    The purpose of this study is to investigate whether correction of iron deficiency with intravenous iron in the form of Ferric Carboxymaltose (Ferrinject®)can improve exercise capacity.

    Study Design:A single centre, double blind randomised placebo controlled trial in subjects with COPD. It will compare the effect of intravenous Ferrinject® to a maximum dose of 15 mg iron/kg body weight vs a placebo of sodium chloride 0.9% solution on exercise capacity via constant rate cycle eronometry. 40 subjects will be enrolled, 20 in the treatment arm and 20 int he placebo arm.

    Expected outcome: Evidence from the field of heart failure has found that correcting iron deficiency markedly improved patients symptoms of breathlessness and also improved exercise capacity. There is need for novel strategies to improve exercise capacity in people with COPD. If this study is positive it would lead to larger studies in this population.

  • REC name

    East of England - Cambridge South Research Ethics Committee

  • REC reference

    16/EE/0355

  • Date of REC Opinion

    10 Nov 2016

  • REC opinion

    Further Information Favourable Opinion