TinA 3 (b) Version 1

• Research type

  Research Study

• Full title

  A Phase III randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (5 µg/day) over 48 weeks as add-on controller therapy on top of usual care in patients with severe persistent asthma

• IRAS ID

  11942

• Contact name

  Graham Oakley

• Sponsor organisation

  Boehringer Ingelheim Ltd

• Eudract number

  2008-001414-25

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  NCT00776984

• Research summary

  The trial is a randomised, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of 5 æg tiotropium over a 48-week treatment period as compared to placebo. Tiotropium inhalation solution delivered by the Respimat© inhaler will be examined as add-on controller therapy on top of usual care in patients with severe persistent asthma. The primary objective of the trial is to evaluate the long term efficacy of tiotropium over placebo on top of usual care in patients with severe persistent asthma as determined by pulmonary function testing, effects on asthma exacerbations, quality of life, asthma control and health care resource utilisation. The secondary objective of the trial is to compare the long term safety of tiotropium with placebo in this patient population.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  08/H0206/74

• Date of REC Opinion

  20 Jan 2009

• REC opinion

  Further Information Favourable Opinion