Tiotropium + Olodaterol (TOnado[TM] 2) in COPD

• Research type

  Research Study

• Full title

  A randomised, double-blind, parallel group study to assess the efficacy and safety of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination (2.5 µg / 5 µg; 5 µg / 5 µg) (delivered by the RESPIMAT) compared with the individual components (2.5 µg and 5 µg tiotropium, 5 µg olodaterol) (delivered by the RESPIMAT) in patients with Chronic Obstructive Pulmonary Disease (COPD) [TOnado TM 2]

• IRAS ID

  82546

• Contact name

  D Singh

• Sponsor organisation

  Boehringer Ingelheim

• Eudract number

  2009-010669-22

• Clinicaltrials.gov Identifier

  NCT01431287

• Research summary

  The purpose of this study is to determine how safe and effective an investigational drug called ‘tiotropium + olodaterol’ is when taken for a long period of time by patients with COPD. The tiotropium + olodaterol will be given using an inhaler called the Respimat©. The Respimat© is different from inhalers that are currently available. It delivers a slow-moving mist of medicine that's easy to inhale and travels deep into the lungs, where it may work better. The Respimat© is environmentally friendly as it is not operated by propellants such as CFC-gases.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/NW/0746

• Date of REC Opinion

  14 Dec 2011

• REC opinion

  Further Information Favourable Opinion