Effectsof glycopyrronium bromide in patients with moderate/severeCOPD

• Research type

  Research Study

• Full title

  An Investigation of the Efficacy, Tolerability and Safety of a Range of Doses of Orally Inhaled Glycopyrronium Bromide (PSX1002-GB pMDI) in Male and Female Patients with Moderate or Severe Chronic Obstructive Pulmonary Disease

• IRAS ID

  114237

• Contact name

  Dave Singh

• Sponsor organisation

  Prosonix Ltd

• Eudract number

  2012-003791-40

• Research summary

  An investigation of the efficacy, tolerability and safety of a range of doses of orally inhaled glycopyrronium bromide (PSX1002-GB pMDI) in male and female patients with moderate or severe chronic obstructive pulmonary disease. This is a single-centre, randomised, placebo-controlled, double-blind, single-dose, five-way crossover dose ranging study in subjects with COPD of 40-75 years of age. Up to 40 subjects will be randomised into the study, which aims to establish the dose-response characteristics of PSX1002-GB pMDI over 24 hours as demonstrated by changes in forced expiratory volume in one second (FEV1) and forced vital capacity (FVC). Blood samples will be collected to establish the pharmacokinetic (PK) profile of PSX1002-GB pMDI over 24 hours

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  12/NW/0754

• Date of REC Opinion

  26 Nov 2012

• REC opinion

  Further Information Favourable Opinion