TioSpir (205.452) Tiotropium Safety and performance in Respimat

• Research type

  Research Study

• Full title

  A randomized, active-controlled, double-blind, double-dummy, parallel group design, multi-center trial to compare the efficacy and safety of 2.5 µg and 5 µg Tiotropium Inhalation Solution delivered by the Respimat® Inhaler with Tiotropium inhalation capsules 18 µg delivered by the HandiHaler®.

• IRAS ID

  49820

• Contact name

  David Halpin

• Eudract number

  2009-015713-51

• Clinicaltrials.gov Identifier

  NCT01126437

• Research summary

  This is a randomised, active-controlled, double-blind, double-dummy, parallel group, multi center trial. The trial objectives are to compare the efficacy and safety of 2.5 μg and 5 μg tiotropium inhalation solution delivered by the Respimat© Inhaler with tiotropium inhalation capsules 18 μg delivered by the HandiHaler©. This means that the trial will compare the effects of the currently available tiotropium HandiHaler© and tiotropium Respimat© treatments on health outcomes and COPD exacerbations over a period of at least two years. Patients will be screened and complete approximately 10-17 treatment visits and one follow-up contact (preferably telephone call) 30 days after the last dose of study medication. Following screening, the patient will be randomised into the double-blind treatment portion of the study (Visit 1) in which they will receive one of the three doses of tiotropium. Two of the doses of tiotropium (2.5 μg and 5.0 μg) will be delivered as inhalation solution via the Respimat© device. The third dose group will receive tiotropium HandiHaler©18 μg. Additional visits will be scheduled after 6 weeks and 12 weeks and every 12 weeks following until the event-driven end of the trial is determined. An event-driven trial means that it is designed to continue until a certain number of fatal events been reported (for this trial, 1,266 fatal events). All patients will remain in the trial until study closeout, so the exact time patients will be on study medication is unknown and is estimated to be between 2 and 3.5 years, but this may change due to the number of fatal events. Patients who discontinue study medication prematurely will continue to be followed every 12 weeks for vital status information until the event-driven end of the study date is defined. A sub-study of pulmonary function testing will be completed in approximately 435 patients per treatment group.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  10/H0803/81

• Date of REC Opinion

  21 Jul 2010

• REC opinion

  Further Information Favourable Opinion