BYM338 in COPD patients with cachexia

• Research type

  Research Study

• Full title

  A randomized, double blind, placebo controlled, multi-centre study to assess the pharmacodynamics, pharmacokinetics, safety and tolerability of BYM338 in chronic obstructive pulmonary disease patients with cachexia

• IRAS ID

  115164

• Contact name

  Michael Polkey

• Contact email

  m.polkey@rbht.nhs.uk

• Sponsor organisation

  Novartis Pharmaceuticals

• Eudract number

  2011-000461-12

• Clinicaltrials.gov Identifier

  NCT01669174

• Research summary

  This study is a randomised, placebo-controlled, double blind, two-arm, parallel design comparing the effect of BYM338 to placebo in COPD patients with muscle wasting ( pulmonary cachexia). this study will explore the relationship between changes in skeletal muscle mass and strength and tasks of physical function in COPD patients with cachexia. Approximately 60 patients with COPD GOLD stage II to IV with associated cachexia will be enrolled into the study, with the aim of a minimum of 50 patients completing.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  13/LO/0578

• Date of REC Opinion

  30 May 2013

• REC opinion

  Further Information Favourable Opinion