TRIGON

• Research type

  Research Study

• Full title

  A MULTINATIONAL, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PLACEBO-CONTROLLED , 2-WAY CROSSOVER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF GLYCOPYRROLATE BROMIDE ADMINISTERED VIA PMDI (CHF 5259), FOR THE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE

• IRAS ID

  152932

• Contact name

  MICHAEL POLKEY

• Contact email

  m.polkey@rbht.nhs.uk

• Sponsor organisation

  CHIESI FARMACEUTICI SPA

• Eudract number

  2013-005268-25

• ISRCTN Number

  n/a

• Research summary

  The purpose of the present study is to determine the effects on health status and lung function (FEV1) of Glycopyrrolate Bromide (CHF 5259) compared with placebo in patients with chronic obstructive pulmonary disease.

  The study is a cross-over design where each subject will receive both CHF 5259 and placebo each for a 4 week treatment period with each period separated by a one week washout period. Subjects will be in the study for 13 weeks.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  14/LO/0752

• Date of REC Opinion

  1 Aug 2014

• REC opinion

  Further Information Favourable Opinion