The effects of a new drug on exercise endurance in COPD patients

• Research type

  Research Study

• Full title

  A multi-center, randomized, double-blind, placebo-controlled, two-period cross-over study to assess the effect of 50µg inhaled NVA237 on exercise endurance in patients with moderate to severe COPD

• IRAS ID

  55918

• Contact name

  Dave Singh

• Sponsor organisation

  Novartis Horsham Research Centre

• Eudract number

  2010-018597-20

• Research summary

  This is a multi-centre, double-blind, randomized, placebo-controlled, two-period cross-over study design. There will be two 3 week treatment periods. The treatment periods will be separated by a 14??day wash-out (wash-out period can be expanded up to 28 days, if required for logistical reasons). A planned number of approximately 80 patients with moderate to severe COPD will be randomized to receive one of two treatment sequences: NVA237 followed by matched placebo or placebo followed by NVA237. No subject replacement is planned.The administration of NVA237 and matched placebo under double blind conditions will be via the Concept1 inhaler device. Administration must be in the morning between 08.00 ?? 11.00 hours. Each subsequent dosing should be at the same time as the initial dosing on Day 1 ( 60 minutes). Each subject will participate in a screening period (maximum 28 days) which consists of 2 screening visits.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/H1008/69

• Date of REC Opinion

  9 Aug 2010

• REC opinion

  Further Information Favourable Opinion