Phase 1 study to compare PK of tiotropium products (QCL117679)
Research type
Research Study
Full title
Phase I randomised, three-period cross-over study in healthy male and female\nvolunteers to compare the pharmacokinetics of tiotropium (as tiotropium\nbromide) delivered from two test products with Spiriva® Respimat® product
IRAS ID
193986
Contact name
Lester Harrison
Contact email
Sponsor organisation
3M Drug Delivery Systems Division
Eudract number
2015-004145-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 15 days
Research summary
The Sponsor is developing test products that deliver tiotropium via inhalation methods. This is for the potential treatment of lung diseases such as chronic obstructive pulmonary disease (COPD). The treatment investigated in this study could treat the narrowing of the airways associated with the disease. \n\nThe study will try to identify how well the body takes up the study drug when given by the test products in development using a conventional pMDI and a prototype pMDI device. This will be compared to how well it is taken up from a product already in use. It will also look at the safety and ease of use of the products.\n\nThis is a 3-way cross-over study, involving up to 28 healthy adult male and female subjects randomly split into 3 groups. Each group will have the study drug from two test products and one reference product, but in different orders. There will be a break of between 5 and 14 days between each study day so that the inhaled drug is cleared from the body before the next dose is given. \n
REC name
Wales REC 1
REC reference
15/WA/0430
Date of REC Opinion
12 Jan 2016
REC opinion
Further Information Favourable Opinion