5 period study comparing 4 tiotropium test products vsSpiriva Respimat

• 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 four test pMDI products with Spiriva® Respimat®

• IRAS ID

  222612

• Contact name

  Annelize Koch

• Contact email

  annelize.koch@simbecorion.com

• Sponsor organisation

  3M Healthcare LTD

• Eudract number

  2017-000260-14

• Duration of Study in the UK

  0 years, 7 months, 18 days

• Research summary

  The Sponsor is developing, a new formulation of Tiotropium to be delivered by pressurised metered dose inhaler (pMDI), for the potential treatment of chronic obstructive pulmonary disease (COPD).

  The aim of this study is to compare the new formulation of Tiotropium with existing marketed formulations using pharmacokinetic measures.

  The study will consist of one screening visit and five treatment periods where up to 50 healthy male and female subjects will receive four inhalations as a single dose of Tiotropium from five study inhalers (four test inhalers and one reference inhaler). They will receive 20mcg Tiotropium from the test inhalers and 10 mcg from the reference inhaler. Doses will be separated by 12-19 days. For each dose administration, regular blood samples will be taken for 24 hours following dosing to allow determination of AUC and Cmax.

• REC name

  Wales REC 1

• REC reference

  17/WA/0027

• Date of REC Opinion

  27 Mar 2017

• REC opinion

  Further Information Favourable Opinion