Cystio(TM) Phase 3

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 mcg administered once daily via the Respimat(R) device in patients with cystic fibrosis

• IRAS ID

  54133

• Contact name

  Stuart Elborn

• Sponsor organisation

  Boehringer Ingelheim Ltd

• Eudract number

  2010-019802-17

• Clinicaltrials.gov Identifier

  NCT01179347

• Research summary

  To date, there have been no formal clinical studies completed using tiotropium in CF patients While there is a large body of evidence demonstrating the efficacy and safety of tiotropium in patients with Chronic Obstructive Pulmonary Disease (COPD), relatively little is known about its efficacy and safety in patients with a diagnosis of cystic fibrosis. Therefore, Boehringer Ingelheim proposed to profile the long acting anticholinergic tiotropium and to generate adequate clinical data for use as a bronchodilator in paediatric and adult CF. The phase III trial (205.438) is a part of the approved Paediatric Investigation Plan (PIP) agreed formspiriva© rispimat© in Cystic fibrosis.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  10/H0408/85

• Date of REC Opinion

  22 Oct 2010

• REC opinion

  Further Information Favourable Opinion