A 2 way crossover study of Tiotropium vs Spiriva Respimat in adults
Research type
Research Study
Full title
Phase I randomised, two-period 21-day cross-over study in healthy male and female volunteers to compare the steady-state pharmacokinetics of tiotropium delivered from a test pMDI product with Spiriva® Respimat®
IRAS ID
222613
Contact name
Annelize Koch
Contact email
Sponsor organisation
3M Healthcare LTD
Eudract number
2017-000261-79
Duration of Study in the UK
0 years, 7 months, 22 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 at steady state.
The study will consist of one screening visit and two treatment periods where up to 40 healthy male and female subjects will receive two inhalations as a single dose of Tiotropium from two study inhalers (one test inhaler and one reference inhaler) for 21 days. They will receive 20mcg Tiotropium from the test inhaler during period 1 and 10 mcg from the reference inhaler during period 2. Periods will be separated by a 14-24 day washout. For each pharmacokinetic dose administration, blood will be collected at pre-dose and for 24 hours following dosing (14 total post-dose blood sampling times) to determine how quickly Tiotropium has been absorbed into the blood stream from the lungs.
REC name
Wales REC 1
REC reference
17/WA/0028
Date of REC Opinion
27 Mar 2017
REC opinion
Further Information Favourable Opinion