PK of Inhaled Tiotropium (QCL117636)

• Research type

  Research Study

• Full title

  Phase I randomised, five-period cross-over study in healthy male and female volunteers to compare the pharmacokinetics of tiotropium delivered from three test pMDI products with two reference (comparator) products

• IRAS ID

  189269

• Contact name

  Lester Harrison

• Contact email

  liharrison@mmm.com

• Sponsor organisation

  3M Drug Delivery Systems Division

• Eudract number

  2015-002787-16

• Duration of Study in the UK

  0 years, 1 months, 21 days

• Research summary

  The Sponsor is developing the study drug, a new formulation of tiotropium, for the potential treatment of chronic obstructive pulmonary disease (COPD). \n\nThe aim of this study is to develop an inhaled formulation of tiotropium that will have an equivalent effect on the body to the existing marketed formulations of tiotropium. The study will compare the new formulation to the existing products. \n\nThe study will consist of 5 study periods involving up to 40 healthy male and female subjects. Subjects will receive a single dose from each of 3 test products and 2 reference products, with a different product being adminstered in each period.

• REC name

  Wales REC 2

• REC reference

  15/WA/0296

• Date of REC Opinion

  7 Oct 2015

• REC opinion

  Further Information Favourable Opinion