1237.19 Tiotropium + olodaterol vs tiotropium in severe COPD

• Research type

  Research Study

• Full title

  A randomised, double-blind, active-controlled parallel group study to evaluate the effect of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination compared with tiotropium on Chronic Obstructive Pulmonary Disease (COPD) exacerbation in patients with severe to very severe COPD.

• IRAS ID

  165798

• Contact name

  Dinesh Saralaya

• Contact email

  dinesh.saralaya@bthft.nhs.uk

• Eudract number

  2014-002275-28

• Duration of Study in the UK

  2 years, 6 months, 3 days

• Research summary

  The purpose of this study is to demonstrate that once daily treatment with tiotropium 5µg + olodaterol 5µg fixed dose combination will reduce the number of COPD exacerbations compared to tiotropium 5µg monotherapy.
  Patients will be randomised by IRT after a successful screening period to one of two treatment arms (tiotropium 5µg + olodaterol 5µg fixed dose combination or tiotropium 5µg). During the 52 week treatment period, the patient will return to clinic 5 times and have four telephone calls from the research team. After the treatment period, there will be three week follow up period after which the patients involvment in the trial will be over.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  14/NW/1454

• Date of REC Opinion

  19 Dec 2014

• REC opinion

  Further Information Favourable Opinion